Disease that can be accessed by a bronchoscopic, surgical or percutaneous biopsy, eligible for biopsy from safety perspective, and agrees to biopsy prior to study; the pre-study biopsy can be waived if there is an archival biopsy specimen that was obtained after the most recent therapy or if the risks of biopsy are judged to be excessive by the study principal investigator (PI)
Disease that can be safely accessed via bronchoscopic, thoracoscopic or percutaneous biopsy, and willingness to undergo biopsy before and after treatment
Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or (if preoperative biopsy was uninformative) - “unknown” histology; RCC must have been confirmed by biopsy within 4 months prior to randomization; if the biopsy clearly demonstrated a benign condition or a different type of cancer, the patient is not eligible to be randomized
Patients must have tumors determined to be easily accessible for biopsy and must be willing to have serial biopsies (with a third biopsy upon evidence of disease progression)
Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at baseline or at molecular pre-screening if applicable, and during therapy on this study. For patients in the phase II part of the study, exceptions may be granted after documented discussion with Novartis. After a sufficient number of paired biopsies are collected, the decision may be taken to stop the collection of biopsies.
Subjects must have measurable disease as demonstrated by residual abnormal tissue at a primary or metastatic site (measurable on CT or MRI) at the time of biopsy; tumor must be accessible for biopsy. In addition, subjects with bone or bone marrow only disease expected to be >75% tumor are eligible to enroll.
7. Willingness to provide consent for biopsy samples;
Participants enrolled must have disease that is accessible for tumor biopsies and must agree to a pre-treatment tumor biopsy
Willingness to provide archival tumor samples; if sample is not available, a biopsy should be considered in patients with safely accessible disease; participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo repeat biopsy in order to continue on protocol
Have a safely biopsiable tumor lesion and be willing to undergo a pre-treatment and on-treatment core biopsy\r\n* Pretreatment tissue should be collected via core biopsy, ideally of a non-target lesion\r\n* Patients may not have intervening systemic anti-cancer therapy between the time of pre-treatment biopsy/resection and initiating study treatment
Patients must agree to have a biopsy of metastatic tissue at baseline, and there must be a lesion that can be biopsied with acceptable clinical risk (as judged by the investigator)\r\n* Patients with unsuccessful baseline biopsies may undergo an additional biopsy attempt (at the same or a different site, determined by the investigator)\r\n* For patients with an intact primary and no metastatic site that can be safely biopsied, biopsy of the primary is acceptable, but must be approved by the principal investigator\r\n* Baseline tumor biopsy may be omitted if the tumor is inaccessible and/or a biopsy is not thought to post exceptionally high procedural risk due to location or other factors
Patients with pancreatic adenocarcinoma; patients must have histologic diagnosis and either locally advanced unresectable or metastatic disease that has failed at least one standard regimen; eight patients will participate in the paired biopsy studies; patient selected for biopsy must have a primary or metastatic non-bone site that is amenable to safe biopsy; bone only lesions are not suitable for biopsy; these patients will provide informed consent for the paired biopsy study (dose expansion phase, arm A)
Patients with colorectal adenocarcinoma; patients must have histologic diagnosis and either locally advanced unresectable or metastatic disease and have previously received oxaliplatin, irinotecan, and a fluoropyrimidine; eight patients will participate in the paired biopsy studies; patient selected for biopsy must have a primary or metastatic non-bone site that is amenable to safe biopsy; bone only lesions are not suitable for biopsy; these patients will provide informed consent for the paired biopsy study (dose expansion phase, arm B)
Availability of a cancerous lesion amenable to biopsy and willing to undergo a pre-treatment biopsy
Patients must have an accessible metastatic lesion for pretreatment core biopsy.
Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy
Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at baseline, and again during therapy on this study.
Patient has received at least one prior line of systemic therapy in the recurrent/metastatic setting; the study chair may grant exceptions to the mandatory biopsy should the treating physician deem that a biopsy is not feasible or unsafe for the patient, and archival tissue is available and provided for study purposes; a conversation with the study chair is required to obtain an exception
For patients enrolled on Phase 2 of study at UCSF, tumor biopsy is required in the subset of patients who have a metastatic lesion amenable to biopsy in the judgment of study investigator and Interventional Radiology
Prior to initiation of study agents, study participants will be highly encouraged to undergo a baseline research core biopsy of their breast tumor; if this is not possible or the patient refuses, the pre-treatment tumor sample must be obtained from their archival diagnostic core biopsy; if definitive surgery is not performed at day 21-27 after study treatment, a second post-treatment research core biopsy will need to be obtained from their breast tumor; for patients undergoing surgery, the second biopsy will be removed from the breast tumor tissue excised during their operation; Note: In the event that the baseline breast tumor biopsy performed for research purposes does not yield adequate tumor tissue for analysis of the primary and secondary endpoints, tissue will be requested from the patient's archival clinical diagnostic core biopsy if it is available; the patient will still remain on study and complete protocol therapy as planned in this unlikely event
Biopsy of a primary or metastatic lesion must have been performed within the past two years; sufficient pathologic material must be available to enable whole exome sequencing at the time of study entry; patients with biopsy samples older than 2 years must undergo a fresh tumor biopsy or should receive approval for enrollment from the principal investigator
For Arm A, patients must have disease that is amenable to biopsy and must be willing to provide consent for a tumor biopsy at baseline (within 30 days of beginning ONC201) and at least 1 on-treatment tumor biopsy.
Mandatory biopsy is required during screening
Limited disturbance of tumor during biopsy.
Suitable for a new tumour biopsy.
Part B: subjects must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry and provide a biopsy suitable for the NGS required for this study.
Unwilling or unable to undergo research biopsy during the baseline (pre-surgical) clinic visit, or inadequate research biopsy obtained during the baseline (pre-surgical) clinic visit (determined by the gynecologic oncologist at the time of the subject’s pelvic exam)
All subjects must agree to pre- and on-treatment tumor biopsies; subjects in whom biopsy is technically not feasible or in whom would result in unacceptable risk, in the opinion of the investigator, may be exempted from the biopsy requirement with discussion with the principal investigator; use of outside archived tumor tissue for a\r\nbaseline biopsy is not permitted
Subject must appropriately be able to complete Screening assessments before beginning treatment for DLBCL, in the judgement of the Investigator. For subjects with bulky disease, B-symptoms, compressive disease, elevated bilirubin due to lymphoma, rapidly progressing adenopathies, or worsening performance status, pre-phase treatment with up to 100 mg/day prednisone, or equivalent, for a maximum of 10 days is permitted prior to beginning the treatment period, at the discretion of the Investigator. A washout period is not required, however, the Screening positron emission tomography (PET), CT, tumor biopsy (if needed), and bone marrow biopsy (if needed) should be completed before initiating corticosteroids.
Women with surgical breast biopsy(s) performed within 3 years or core biopsy(s) performed within 1 year prior to the screening mammogram.
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline; participants can be exempt if archival tumor tissue has been collected within 12 months of study enrollment that the principal investigator deems it appropriate/sufficient for analysis on this protocol; biopsy of a lesion outside of the potential radiation treatment field is preferred to maintain consistency across cohorts
All patients with biopsy-accessible disease must be willing to undergo paired research biopsies; these biopsies will occur 5-48 hours after the cycle (C)1 day (D)1 cisplatin dose (i.e. C1D2 or C1D3) and 5-8 hours (hrs) (+/- 24 hrs) after the last dose of AZD1775 on C2D3; the exact timing of the biopsy relative to receipt of study treatment should be accurately recorded\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* Research biopsies requiring general anesthesia are not allowed on this protocol unless a biopsy is being obtained simultaneously for clinical reasons, in the judgment of the patients’ treating physician\r\n* Patients who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to continue protocol therapy; they will not be required to undergo a repeat biopsy attempt\r\n* If dosing is delayed placing the biopsy outside of the allowable window, the biopsy should be rescheduled to be within the window; if not feasible, the biopsy should be obtained as close to within the window as possible\r\n* Fine needle aspirates (FNA) is not allowed
Has ?1 distant, discrete non-injected lesion which is amenable to biopsy.
Available biopsy of primary tumor with adequate samples
Invasive features on colposcopy and the biopsy specimen
Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/ baseline or at molecular pre-screening if applicable, and during therapy on this study.
The participant’s primary tumor is accessible to biopsy in the outpatient clinic setting and the participant is willing to have baseline and end of study (day 15-26) 4 mm punch biopsies of tumor and adjacent visually normal appearing tissue for biomarker analysis\r\n* If the participant has a biopsy-confirmed cancer, the baseline biopsy to collect tissue for biomarker analysis will be in addition to the pre-study diagnostic biopsy\r\n* If the participant is having surgical treatment, the end of study biopsies may be collected at the time of surgery unless surgery is delayed beyond day 26\r\n* If the participant is not having surgical treatment, the end of study biopsies will be collected prior to initiation of non-surgical treatment
For Parts 1 and 3, eligibility may be based on local read of fresh or archived tumor biopsy. Archived or fresh FFPE biopsy must be provided for retrospective centralized review.
Participant’s core biopsy slides suggest that later re-sectioning will not contain sufficient tumor to allow for an adequate evaluation of Ki67 and TUNEL assays, at a minimum
Participants enrolling to the HR or replicative stress cohorts during stage 1 must have disease that is amenable to biopsy and be willing to undergo a pre-treatment tumor biopsy.
Participants enrolling to the HR or replicative stress cohort during stage 1 may not be on anticoagulant therapy unless the treating investigator has deemed it safe to temporarily hold to facilitate the pre-treatment tumor biopsy.
Phase I: Patients with a site of disease amenable to biopsy, and willing to undergo a new tumor biopsy at screening, and during treatment.
Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
Patient is able to provide tissue from diagnostic core biopsy of tumor lesion(s)\r\n* Notes:\r\n** 4 cores may be taken for lesions > 1.5 cm, otherwise 2 cores may be taken from recent biopsy\r\n** Patient can be registered, randomized, and start study treatment prior to specimen shipment
Patients in the Phase 1a dose escalation combination cohorts must have at least 1 tumour lesion amenable to biopsy and must be medically fit and willing to undergo a biopsy during screening and, unless clinically contraindicated, after 2 weeks on monotherapy.
A minimum of 10 patients with mCRPC, CRC and 'other' tumors will be required to have a site of disease that is safely accessible for biopsy (paired) upon enrollment. Accessible lesions are defined as those which are biopsiable (at screening) and amenable to repeat biopsy (after 2 weeks of monotherapy), unless clinically contraindicated. In the case that the second sample is not taken, the patient will remain in the study and there will be no penalty or loss of benefit to the patient and they will not be excluded from other aspects of the study. The tumor-specific cohorts will be closely monitored to ensure the desired number of biopsiable patients are enrolled. The requirement for biopsies must be made clear to each patient at the time of initial approach by the Investigator.
Presence of >= 1 tumor lesion not included as a RECIST 1.1 target lesion which is assessed by investigator and/or radiologist as likely to be amenable to percutaneous biopsy by punch, computed tomography (CT)-, or ultrasound-guided core needle biopsy for serial sampling on treatment
Neg pregnancy test Part A extension only: • Has a primary tumor or a metastatic site that is accessible for pre- and post-dose biopsy without subjecting patient to high level of risk Part B only:
Subjects are willing to undergo a biopsy to confirm lower GI aGVHD. Biopsy results are not needed to initiate treatment. However, if aGVHD is not confirmed histologically, treatment with F-652 will be discontinued.
Consent for a tumor biopsy at screening
All patients except cohort 6 must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy; for cohort 5, the second biopsy at progression is mandatory for the responders (PR/CR/stable disease [SD]) >= 4 months
Patient must agree, as part of the informed consent, to provide blood and archived tumor samples for molecular correlates, pharmacokinetics and pharmacodynamics; patients in the expansion cohort A must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy; patients in cohort B group 3 and 4 must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy; this requirement may be waived after discussion with the principal investigator as long as a minimum of 5 patients in cohort B group 3 and 10 patients in cohort B group 4 are able to undergo the required biopsies
COHORT A: Patients must have accessible tumor sites for biopsy and must agree to pre-treatment and post-treatment biopsies
Patients enrolled at Dose Level 6 or higher in the phase I portion of the trial must have at least one tumor mass suitable and easily accessible for excisional biopsy, or alternatively, accessible for CT or ultrasound guided core needle biopsy. The procedure must be able to be performed with minimum morbidity.
Patients must have an accessible primary tumor or metastasis, and be willing to have a pre-treatment and post-treatment tumor biopsy (at 6 to 8 weeks after beginning)
Participants must be willing to undergo one mandatory on-study tumor biopsy following a 4 week, single cycle induction treatment of olaparib. A second on-study biopsy at time of disease progression is optional, but not mandatory.
Must have at least one tumor site accessible for a biopsy
Patients must agree to have a biopsy of metastatic tissue at baseline and on-treatment, and there must be a lesion that can be biopsied with acceptable clinical risk (as judged by the investigator)\r\n* Patients with unsuccessful baseline biopsies may undergo an additional biopsy attempt (at the same or a different site, determined by the investigator)\r\n* For patients with an intact primary and no metastatic site that can be safely biopsied, biopsy of the primary is acceptable, but must be approved by the principal investigator
Have at least 2 tumor lesions accessible for biopsy
For biopsy identified participants: be willing to undergo repeat biopsy of a tumor lesion before and after treatment; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may be exempted from this requirement after consultation with the principal investigator; note: enforcement of biopsy requirement may come into effect for all participants depending on the state of accrual compared with number of obtained biopsies at any point in the study
Subjects must be willing to undergo 2 sets of core needle biopsies (pre-treatment and at 6-8 weeks on therapy) if there are lesions amenable to biopsy; subjects without a lesion amendable to biopsy will still be permitted to enroll provided they have an archival tumor sample for PD-L1 IHC testing; an optional core biopsy will be requested at progression (Stage 2 only)
All subjects must agree to pre-treatment tumor biopsy; subjects in whom biopsy is technically not feasible or in whom would result in unacceptable risk, in the opinion of the investigator, may be exempted from the biopsy requirement with discussion with the principal investigator
Hepatic metastases present which are amenable to biopsy
At least 1 lesion accessible for biopsy
STUDY ENTRY: Confirmation of diagnosis (by surgical excisional/incisional biopsy or imaging-guided core biopsy), and patients for whom the plan of management will include NACT followed by ICS. The decision to proceed with NACT will be at the treating physician’s discretion and include patients with advanced stage disease considered at low likelihood for optimal cytoreduction with primary debulking surgery.
Must have a tumor lesion safely accessible for biopsy per the investigator’s discretion; while a soft tissue metastasis is preferred for a biopsy, a bone metastasis is allowed for biopsy as long as enough cores can be obtained; a biopsied lesion cannot be used for target lesion for response assessment
Pathologic confirmation of respective malignancies; biopsy of metastatic disease is preferred but not mandatory
Biopsy with less than 20% of tumor removed
Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR TKI; or willing to undergo a new tumor biopsy prior to registration (for the dose escalation portion only this requirement can be waived if T790M status has already been determined using a local assay)
At least 30 days from any major surgeries including brain biopsy and have complete resolution of its effects
Consent to participate in the correlative studies and should have available tumor tissue for tumor biopsies; acceptable biopsies include surgical biopsy, core biopsy or punch/surgical tumor biopsies (of accessible lesions)
Tumor accessible for biopsy
Able to submit an archival tumor specimen (primary or metastatic site) and a discussion is documented with trial investigator at screening that patient will consider providing tissue from a newly obtained core or excisional biopsy of a tumor lesion at baseline and a second biopsy 9 weeks after starting trial treatment, unless tumor is considered inaccessible or biopsy is otherwise considered not in the patients best interest. Participation in this trial is not contingent on patient consenting to optional tumor biopsies.
At least 30 days from any major surgeries including brain biopsy and have complete resolution of its effects
Patients who have had a multiparametric MRI of the prostate performed and have undergone transrectal systematic biopsy plus biopsy of any volumes considered suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before signing consent.
No features supporting an alternative diagnosis by transbronchial biopsy, bronchoalveolar lavage (BAL), surgical lung biopsy, culture and non-culture based data, if performed
Subjects must have disease that can be safely biopsied (for RP2D biopsy expansion cohort only), and agree to undergo a pretreatment and on-treatment biopsy.
Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic\r\n* Uncomplicated previous transrectal ultrasound (TRUS) biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy)
Is willing to provide archival tumor tissue from a biopsy performed within 6 months of progression during treatment with erlotinib, gefitinib, or afatinib OR has at least one lesion, not previously irradiated, amenable to core biopsy and is willing to undergo screening tumor biopsy.
Core biopsy, including bone marrow biopsy within 2 days prior to study drug administration.
The subject has biopsy accessible tumor and is willing to undergo biopsy prior to planned protocol treatment
For biopsy identified patients: be willing to undergo repeat biopsy of a target lesion before treatment and after radiation; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may be exempted from this requirement after consultation with the principal investigator
Patients must agree to undergo two research biopsies of (a) malignant lesion(s); the investigator must also judge that the patient has tumor(s) safely accessible for biopsy; patients may be exempt from the second biopsy if after the performance of the first biopsy it is felt that a second biopsy would be unsafe for the patient; if the patient has only one Response Evaluation Criteria in Solid Tumors (RECIST) measurable target lesion for response assessment, research biopsies must not be performed on that target lesion
Patient willingness and disease accessible to pre-treatment, on-treatment tumor, and progression biopsies (core biopsies); a cell block from a pleural effusion may be substituted for a core biopsy; in select cases, patients may be allowed to enroll without a pre-treatment biopsy and/or continue treatment without an on-treatment biopsy (even if a pre-treatment biopsy is obtained) after speaking with the sponsor if performing the biopsy is technically challenging, poses significant risk to the patient, or may result in significant discomfort
Tumor deemed amenable to biopsy by core for metastatic site or endoscopic biopsy for primary tumor (for both before and on-treatment biopsies)
Pre-treatment biopsy must establish the diagnosis AND have enough remaining tissues to satisfy the mandatory research studies
Lymphoma that is amenable to safe pre-treatment and post-treatment biopsy; the safety of the procedures will be determined by the treating physician and the surgeon or other proceduralist, in consultation with the principal investigator (PI), and in accordance with standard clinical practice; acceptable sites of disease include, for example: (1) palpable tumor mass that is accessible under direct visualization or sonogram, (2) non-palpable tumor tissue that is accessible for biopsy under computed tomography (CT) or sonogram guidance, (3) bone marrow
Additional criteria for expansion cohorts: A) patients must have histologically-confirmed advanced or recurrent ovarian cancer with RPA or that had progression during prior PARP inhibitor treatment, endometrial cancer with RPA, or other solid tumor types with RPA; B) measurable and biopsy-accessible disease; C) patient must be willing to undergo biopsy procedure; D) prior treatment with PARP inhibitors is allowed
At least two sites of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; one of which must be amenable to treatment with SAR and accessible for a mandatory pre-treatment biopsy and a post-treatment biopsy at physician discretion; if a pulmonary nodule is being considered for SAR it must range in size from 1-5 cm
Available tissue from prior biopsy (minimum of 10 unstained slides), or willing to undergo core biopsy to obtain tumor material. Biopsy will be mandatory for patients with recurrent disease
Patients with tumor that is felt to be accessible to biopsy must be willing to provide tissue from a newly obtained core biopsy of a tumor lesion at baseline; biopsies will be obtained up to 1 week (7 days) prior to initiation of treatment on cycle 1, day 1; patients who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
However, if the treating physician and diagnostic radiologist strongly suspect PET positivity, the patient should not be enrolled even if the biopsy is negative (to exclude patients with false-negative biopsy)
Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors; residual measurable tumor is required for enrollment on study as outlined above
Patients with > 10% blasts on a day +14 bone marrow biopsy following 7+3 may either be enrolled or may be treated with a course of standard re-induction (e.g. 5+2 or similar) and then re-evaluated for response; eligible patients will meet any of the above criteria on a subsequent biopsy
Positive serum anti-poliovirus titer >= 1:8 prior to biopsy
Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
Tumor blocks available from previous surgery/biopsy, or if not available, patients willing to have biopsy
Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable.
Biopsy is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with pure seminoma
Patient must have disease amenable to biopsy and must agree to have one baseline biopsy
Patient must provide a tumor biopsy as the time of progression on Arm B; if a patient does not have a tumor lesion amenable of biopsy or it has been unsafe for a biopsy to be performed, cross-over will be allowed
Agree to undergo a biopsy of at least one metastatic site (fresh biopsy of primary prostate only allowed if there is clear local disease and no other measurable disease site or biopsiable bone lesion) to determine DNA repair defects; however:\r\n* Adequate archival metastatic or primary disease tumor tissue can be used if available in lieu of a new biopsy; these patients will only be eligible for protocol therapy if the biopsy has tumor that is positive for DNA repair defects\r\n* Patients with known DNA damage repair defects based on prior appropriately validated metastatic or prostate tissue analysis may be used in lieu of new biopsy/analysis based on central site evaluation of quality of the biopsy and analysis\r\n* Patients with known germline DNA repair defects are eligible without a biopsy; however it will be highly desirable that they undergo a metastatic (or fresh prostate biopsy if there is clear local disease and no other measurable disease site or biopsiable bone lesion) disease biopsy to better define the scope of the DNA repair defects in the current disease context
Stereotactic biopsy will not be allowed unless there is plans for second surgery to remove >= 80% of the tumor
Subject that underwent excisional biopsy of the primary tumor.
Subjects must be able to provide tissue from 2-3 separate biopsy procedures that will be completed throughout the course of the study; day 1 biopsy: required only if a pre-study biopsy is not available or if a subject has received prior radiation at a tumor site and will be re-radiated at that tumor site as part of the proposed study; the pre-study biopsy may be obtained up to 6 weeks prior to initiation of treatment on day 1; there should be no intervening treatment in between the pre-study biopsy and day 1; day 22 biopsy: required; day 43 biopsy: required
Hemoglobin >= 9 prior to biopsy
Positive serum anti-poliovirus titer prior to biopsy
Patient must consent to two mandatory biopsies and have tumor amenable to biopsy
Willing to undergo tumor biopsy at baseline and during treatment (during week 6 or 7); please note that tumor biopsy is not needed in subjects where the tumor is not accessible or if tumor biopsy is considered not in patient’s best interest
Phase II only: participant agrees to provide tumor biopsy tissue before treatment, blood samples at the start of treatment and at multiple times during the study and, a tumor biopsy at the end of the trial or after disease progression
Tumor available for fresh biopsy (two biopsies – pretreatment as regards enzalutamide, and during treatment at 4 weeks); the patient will be asked if they would be willing to provide a third biopsy at time of progression
Availability of a diagnostic or pre-chemotherapy tissue biopsy is required (cytologic specimens or bone biopsies not accepted); this biopsy must be within 6 weeks of starting initial therapy; a minimum of 20 5um slides or block is required
Adequate archival tissue must be available from the prior 3 months to signing consent; if not, an adequate tumor specimen obtained by either excisional biopsy, incisional biopsy or core needle biopsy must be sent to the central pathology lab for evaluation; the material must measure at least 0.8 x 0.1 cm in size or contain at least 100 tumor cells
At least one lesion (metastasis or primary tumor) being considered accessible by non-high-risk collection procedures for biopsy.
Willing to provide tumor tissue amenable to ultrasound or computed tomography (CT)-guided biopsy for biomarker analyses\r\n* Patients with malignant ascites are permitted to participate and provide ascites samples for biomarker analyses\r\n* Patents receiving radiation to a single metastatic site in which only the primary tumor is accessible for biopsy by endoscopy will also be eligible
An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy
Subjects must consent to provide archived tumor specimens for correlative biomarker studies; tumor tissue must be identified and availability confirmed prior to initiation of study therapy; in the setting where archival material is unavailable or unsuitable for use, or there have been multiple intervening therapies subjects must consent and undergo fresh tumor biopsy; a tumor lesion planned for biopsy must not be an irRECIST target lesion unless there are no other lesions suitable for biopsy and lesion used for biopsy is >= 2 cm in longest diameter
Tumor amenable to biopsy will be mandatory for this study
Must have neuroblastoma lesion(s) amenable to non-significant risk biopsy for next generation sequencing (NGS) profiling at Foundation Medicine; biopsies of the brain; lung/mediastinum; pancreas; endoscopic procedures extending beyond the lung, stomach, or bowel; or other significant risk biopsies will not be performed as part of this study; if a subject has tumor tissue archived from a previous biopsy, that tissue may be sent to Foundation Medicine for NGS and an additional biopsy will not be required
At least 1 lesion amenable for outpatient biopsies; this should be a cutaneous or palpable metastatic site or a deeper site accessible by image-guided biopsy that is deemed safe to access by the treating physicians and interventional radiologists; patients without accessible lesions for biopsy but with prior tissue available from metastatic disease would be eligible at the investigator’s discretion
Patients must be willing to undergo a biopsy of the cancerous tissue if one was not taken within the previous year, prior to drug initiation if tumor block is not available; biopsy must be done within 14 days of first planned drug dose
Paired tumor biopsy is mandatory for all subjects enrolled in the Expanded cohort; subjects should agree to and be eligible for paired tumor biopsy
Patients must have disease that is amenable to biopsy and be willing to provide the same; NOTE: Patients in whom a baseline biopsy is attempted, but is not successful, will still be considered eligible for the study; in addition, if the primary oncologist has a concern regarding the feasibility of a biopsy, it may be omitted after consulting with the protocol chair
Dose Escalation: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment) or to provide an available archival tumour sample if taken <3 years prior to enrolment if a new tumour biopsy is not feasible with an acceptable clinical risk.
Dose Expansion Cohort Group 1 and 2: At least one tumor lesion amenable to repeat core needle biopsy or punch biopsy without unacceptable risk of a major procedural complication
If they have previously undergone a VATS, or they do not have a free pleural space to allow for a VATS procedure, then they must be able to undergo a computed tomography (CT) or ultrasound guided needle biopsy to obtain baseline tissue if it is feasible; if this is not anatomically feasible, then they must be able to provide at least 15 unstained slides or a tumor block from their prior biopsy
For biopsy identified patients: be willing to undergo repeat biopsy of a tumor lesion before treatment and after radiation; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may be exempted from this requirement after consultation with the principal investigator\r\n* Note: enforcement of biopsy requirement may come into effect for all patients depending on the state of accrual compared with number of obtained biopsies at any point in the study
Biopsy confirming metastatic breast cancer and retinoblastoma protein (Rb) positivity by immunohistochemistry prior to enrolling on this protocol is required; biopsy must be obtained immediately before study enrollment; no intervening treatments are allowed
If an accessible lesion is present, a biopsy will be performed within 6 weeks of the start of study intervention; the results of the biopsy must be obtained prior to initiation of study intervention
Patients acceptance to have a tumor biopsy
The presence of metastatic disease amenable to computed tomography (CT) or ultrasound guided biopsy; this may include thoracolumbar vertebral bodies, pelvis, femur or humerus or soft tissue or nodal metastasis amenable to biopsy (excluding lung or pleural lesions)
Patients with documented HER2-positive metastatic disease based on most recent biopsy
At least 2 anatomically distinct lesions accessible for biopsy.
Ability to have a skin and tumor biopsy from any site; patients without accessible tumor for biopsy will be considered on a case by case basis\r\n* Patients who cannot be biopsied will not be replaced (although up to 5 ineligible/inevaluable patients can be replaced)\r\n* Patients without accessible tumor for biopsy must provide archived tumor from the most recent biopsy available
Consent to provide archived tumor biopsy material (all patients)
Patients who had excisional biopsy for diagnosis of their cancer (i.e., instead of a core biopsy)
Must be able to provide biopsy specimens obtained ?3 months for biomarker analysis. If bone marrow biopsy was performed 3 months before screening but subject had anti-cancer treatment after biopsy, the bone marrow biopsy and aspiration should be repeated CLL Participants:
Tumor that is accessible for mandatory biopsy
Agree to undergo a core biopsy of the pancreatic tumor for both research and diagnosis purposes if a prior core biopsy is not performed or the core biopsy specimen is not available for the research purpose of this study
The subject must agree to undergo the pre- and post-treatment research biopsies if a non-osseous metastatic site is available for biopsy; the pre-treatment biopsy will be standard of care, and used for diagnostic purposes to assess ER/ progesterone receptor (PgR) / HER2 status and confirm the presence of breast tumor cells; the post-treatment (day 11) biopsy will be performed for research purposes; both the pre- and post-treatment biopsies will be assessed on-site by a pathologist by touch-prep to ensure that the biopsied tissue contains tumor cells
Adequate archival tissue for determination of EGFR-mutation status and PD-L1 status with a leftover cell block (or equivalent) for additional immune correlates from a tumor lesion biopsied in the last 60 days that has not been previously irradiated occurring: 1) after progression on erlotinib and no intervening systemic treatment between biopsy and initiation of MK-3475 and afatinib or amenable to repeat biopsy
Tumor blocks available from previous surgery/biopsy, or if not available, patients willing to have biopsy
Patients in the dose expansion part must have tumor that is amenable for biopsy
Subject has no tissue from UPCC19809 end of study (EOS) biopsy and unwilling to undergo screening biopsy
Patients must have tumor suitable for biopsy (as assessed by trained specialists in interventional radiology) and medically fit to undergo a biopsy or surgical procedure OR if patients do not have a tumor suitable for biopsy but have another tissue (preferably progressive metastatic site) available for molecular evaluation (biopsy will be performed through Ohio State University [OSU]-13053 study or the University of Michigan [UM] Precision Cancer Study)
Histologically proven non-small-cell lung cancer (core biopsy required)\r\n* Squamous or non-squamous histology\r\n* Diagnostic core biopsy specimens must be reviewed by a faculty pathologist at Sidney Kimmel Comprehensive Cancer Center (SKCCC) or Memorial Sloan Kettering Cancer Center (MSKCC)\r\n* Either a formalin fixed paraffin block that has been confirmed by a pathologist to contain tumor or a minimum of twenty 5-micron tissue sections (slides) of tumor biopsy sample must be available for biomarker evaluation (study pathologist must review for adequacy of sampling); this can be obtained from archived tissues if adequate, or from a new biopsy as needed
Biopsy-proven relapsed (response to last treatment > 6 months duration), refractory (no response to last treatment or response duration < 6 months) or residual Hodgkin lymphoma; NOTE: re-biopsy is necessary unless the patient has had a previous biopsy < 180 days prior to registration on this protocol with no intervening therapy and tissue is available for translational research studies
Patients must agree to undergo two separate biopsies of a malignant lesion; biopsies do not need to be done if one of the following apply:\r\n* If either the site investigator or person performing the biopsy judges that no tumor is accessible for biopsy or that biopsy poses too great of a risk to the patient (if the only tumor accessible for biopsy is also the only lesion that can be used for RECIST v1.1 response evaluation, then the patient may be exempt from biopsy after discussion with the MSK principal investigator)\r\n* The goal will be to have a minimum of 6 patients from Cohort A and 3 patients from Cohort B attempt to have one or both of these research biopsies done (for a total of 9 patients total); accrual may be limited only to subjects for whom tumor is accessible for biopsy and attempt at biopsy is considered safe if continued enrollment of those who are not candidates for biopsy make it impossible to reach the accrual goals for research biopsies described above (e.g., if 19 [of 25] patients are accrued to Cohort A without any biopsies having been obtained within the cohort, then all further subjects who are registered to that cohort must qualify for attempted research biopsy in order to be enrolled into the study [i.e., subjects who would have been excluded from having biopsies done due to the above reasons would be excluded from participating in the study; these conditions also apply to Cohort B])
Patient amenable to liver tumor biopsy
Archival tissue (10 unstained slides - 5 micron sections) from a core biopsy performed and received within 30 days before signing consent or ability to have a fresh core biopsy performed\r\n* Biopsy cannot be from cytology or bone specimen\r\n* Biopsy site must be amenable to re-biopsy at the end of study\r\n** In the event that the tumor resolves on treatment, another site amenable to biopsy will be selected
Subjects meeting the American Association for the Study of Liver Disease (AASLD) criteria may be randomized without a biopsy, but will undergo a biopsy during the RFA procedure unless contraindicated or unattainable.
If prior standard-of-care pre-treatment biopsy is inadequate for analysis by immunohistochemistry, and the patient is unwilling to undergo an additional biopsy procedure
Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer
Tumor specimens must be available for immunological studies, either from a previous biopsy or a new biopsy obtained before the initiation day 1 of the study
Patients must agree to have a biopsy at baseline and on treatment
Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy)
cMet expression in >= 30% tumor cells as demonstrated on immuno-histochemistry analysis of archival slides; punch biopsy or percutaneous core biopsy may be offered to Cohort 1 patients
At least 1 lesion amenable for an outpatient biopsy; this should be a cutaneous or palpable metastatic site or a deeper site accessible by image-guided biopsy that is deemed safe to access by the treating physicians and interventional radiologists; patients without accessible lesions for biopsy but with prior tissue available from metastatic disease would be eligible at the investigator's discretion
Patients whose tumor is not accessible for a core biopsy
Phase II cohorts only: Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Phase Ib patients need not have disease accessible to biopsy
Histologic confirmation of cancer will be required by biopsy, prior surgery, and re-biopsy at the discretion of the treating physician
Must be willing to provide a tumor biopsy specimen 9 weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator.
Core biopsy, including bone marrow biopsy, within 2 days prior to study drug administration
Consent to undergo on treatment biopsy if tumor is accessible and safe to biopsy
Baseline tumor biopsy must be adequate
Patients must have measurable metastatic disease amenable to biopsy; patients who decline to undergo a biopsy for this trial will be ineligible
Treatment with any of the following medications within 4 weeks before the baseline diagnostic biopsy is taken:
Consent to tumor biopsy from accessible tissue (optional in part 1, mandatory in part 2)
All patients must have tumor specimens adequate for analysis of EGFR mutations and have tumor accessible to biopsy and must consent to biopsy.
DCIS diagnosed with core biopsy
At least one lesion (metastasis or primary tumor) being considered accessible for a biopsy
Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time (biopsy not required, even if partial response to intervening therapy); 2) Refractory disease (i.e., less than a partial response to frontline therapy, including a minimum of 4 cycles of chemotherapy) (no biopsy is required for eligibility for this study); 3) Persistent disease after at least a partial response to frontline therapy (i.e., patient has had at least a partial response to frontline therapy but still has residual disease by MIBG scan, CT/MRI, or bone marrow) (patients in this category are REQUIRED to have a biopsy [bone marrow biopsy included] of at least one residual site demonstrating viable neuroblastoma)
RENAL COHORT: Patients with an outside biopsy within 12 months is allowed for entry requirements; during the screening phase, patients without a tissue diagnosis may undergo a renal biopsy for histologic confirmation on PA13-0291
All patients must consent to pre-treatment biopsy of the tumor if it can be done safely (as judged by the investigator) during screening. Week 10 on-treatment biopsies will be required for a minimum 10 patients. After 10 paired biopsies have been obtained then week 10 on-treatment biopsy will be made optional.
Consent to undergo biopsy from a newly obtained core or excisional biopsy of a tumor lesion before study drug administration, and during treatment; biopsy in case of progressive disease is optional
Patients must have biopsiable tumor and agree to study biopsy
The patient must have measurable disease according to RECIST v1.1 and must have one site amenable to biopsy that, in the opinion of the investigator and/or interventional radiologist, is likely to yield acceptable tumor sample for a core biopsy per the below pathology criteria
Histologically confirmed adenocarcinoma of the prostate: screening and on-treatment biopsy is mandatory. If adequate number of paired biopsy samples are collected (>=20 paired samples for each dose level in each Arm, unless an Arm is closed early), then further biopsy sampling will be considered based on available data; screening biopsy can be waived if patient had a recent biopsy after failure of ADT therapy (within 30 days) and the biopsy sample is secured to be sent as screening biopsy for this study.
For the expansion patients must provide a fresh tumor biopsy at enrolment
Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy
Must have two biopsy accessible lesions:
Patient must agree to provide fresh biopsy specimens and peripheral blood samples at the time of screening and during the study
TUMOR BIOPSY SEQUENCING: Patient must have tumor amenable to percutaneous or excisional skin biopsy and be willing to undergo a tumor biopsy or biopsy samples (formalin-fixed paraffin-embedded [FFPE] blocks) collected on another study or from a procedure performed due to medical necessity may be acceptable if collected within 6 months prior to registration on MPACT and providing that the patient has not received any investigational or targeted treatment since that time
TREATMENT: Patient must have predefined targeted mutation in tumor biopsy
Patients must have tumors determined to be easily accessible for biopsy and must be willing to have serial biopsies (with a third biopsy upon evidence of disease progression); tumor biopsies will be performed on the most accessible biopsable site of disease; all possible precautions to avoid complications will be taken, including discussions in multidisciplinary meetings, if needed; patients affected by glioma will not be considered for study biopsies
If no adequate archival tumor biopsy is available, patients must undergo a new biopsy
For enrollment in the first stage of Cohort B, patients must have accessible pre-treatment and post-treatment (4-6 weeks) tumor for biopsy
Inability to test core biopsy for study markers
For lymphoblastic lymphoma: diagnosis may be made by i) biopsy of involved site (e.g., node, mediastinal mass), or ii) by cytology from pleural fluid or other fluid collection or iii) by marrow aspirate/biopsy demonstrating < 30% involvement by lymphoblasts (confirmed by flow cytometry, immunohistochemistry, cytogenetics and/or FISH studies) in a patient with evidence of lymphomatous masses by radiographic studies; note: marrow aspirate and/or biopsy must be performed in patients with lymphoblastic lymphoma prior to study entry to confirm that patient does not meet definition of ALL; in rare circumstances, lymphoblastic lymphoma patients may be registered prior to marrow aspirate/biopsy if it is felt that the procedure cannot be safely performed; permission in advance by principal investigator or designee is required
Patients with \easily accessible disease\\r\n* Patients with skin or chest wall disease amenable to a punch biopsy under local anesthesia are required to undergo a baseline and cycle 2 biopsy as part of this protocol\r\n* Patients with a breast mass or axillary lymph node amenable to an image-guided core biopsy are also required to undergo a baseline and cycle 2 biopsy as part of this protocol\r\n* Patients with malignant ascites fluid or a malignant pleural effusion of sufficient volume to be amenable to tap (either in-office or image-guided) are also required to undergo a baseline and cycle 2 biopsy as part of this protocol\r\n* Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n* Patients will be approached at the time of progression about providing an optional tissue sample at that time; however, the time of progression biopsy will be optional
Patients with \accessible disease\\r\n* Patients with sites felt to be accessible to an image-guided or incisional biopsy in the opinion of the patient's treating oncologist and physician performing the procedure, and not meeting the criteria for \easily accessible disease\ are required to undergo a baseline biopsy as part of this protocol; such sites may include, but are not limited to: liver, lymph nodes, soft tissue, lung, chest wall, and bone\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons (i.e. is clinically indicated), and excess tissue that would otherwise have been discarded is then used for research purposes; if a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol\r\n* Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n* Some patients may have had a clinically indicated biopsy upon recent disease progression and agreed to submit tissue to their institution's frozen tumor bank; if the tissue was processed as specified in this protocol, no additional pre-treatment biopsy is required if that specimen can be used for the correlative studies described in this protocol\r\n* Patients will be approached at the time of progression about providing an optional tissue sample at that time; however, the time of progression biopsy will be optional
Other patients\r\n* Patients who do not have biopsy-accessible disease are not required to undergo a biopsy as part of study participation\r\n* In addition, patients who are being treated with therapeutic doses of anticoagulant(s), are not required to undergo a biopsy as part of study participation; if it is felt clinically appropriate despite anticoagulation (i.e. a skin punch biopsy, etc) by the treating physician, a biopsy is allowed, it is simply not required\r\n* The sites of metastatic disease and reason that the disease is not biopsy-accessible should be documented in the medical record and case report form(s)\r\n* Patients who do not undergo baseline biopsy must have their study participation approved by the overall primary investigator (PI) before start of protocol therapy; only patients who have biopsy inaccessible disease may enter the study without the requirement for baseline biopsy
Cohort II (MTD): willing to provide the biologic specimens as required by the protocol; note: this is part of the mandatory translational research component; note: patients with the only tumor accessible for biopsy in the pancreas will not be eligible as core biopsies are associated with significant increase in risk for the patient
Be willing to undergo a core or excisional biopsy of a bone metastasis prior to study drug initiation for tumor tissue; newly-obtained is defined as a specimen obtained up to 12 weeks (84 days) prior to initiation of treatment on day 1; bone biopsy can have been done prior to screening; archival specimens of bone metastasis are permitted if done for other purpose and available\r\n* If biopsy is non-diagnostic, patient must undergo repeat biopsy as proof of tumor tissue by pathology review; proof of tumor specimen is required for eligibility
Biopsy accessible tumor deposits
Transrectal ultrasound-guided biopsy with >= 10 systematic biopsy cores and >= 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI\r\n* Histologically-confirmed adenocarcinoma from targeted biopsy cores \r\n* Overall Gleason score not to exceed 3 + 4
Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review)\r\n* Minimum of 10 biopsy cores\r\n* Gleason score 6 or 7\r\n* Unilateral cancer (only right-sided or left-sided, not bilateral)
COHORT EXPANSION PHASE: At least one tumor lesion amenable to core needle biopsy without unacceptable risk of a major procedural complication (one pretreatment and at least one on-treatment biopsy will be performed)
Osteosarcoma, neuroblastoma and melanoma that have been treated with standard frontline therapy and are judged to be incurable with standard therapy, based upon the fact that they are unresectable, metastatic, progressive/persistent or recurrent; evaluable disease must be present\r\n* For all histologies except osteosarcoma and neuroblastoma, pathologic review of frozen tissue must document GD2+ expression; positive expression is defined as at least 2+ expression (0-4+ scale) in > 50% of the tumor cells using anti-GD2 monoclonal antibody (mAb) 14G2a; if adequate archived frozen tissue is available, this may be utilized, or if not, patients may undergo biopsy following enrollment to obtain tissue to assess GD2 expression, with the following restrictions\r\n* Patients with histologies other than osteosarcoma or neuroblastoma must have adequate accessible tumor for biopsy (at least 1 cm diameter)\r\n* Procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous needle or core biopsies, thoracoscopic excision or open biopsies of readily accessible lesions; pulmonary lesions may be biopsied but extensive surgery such as thoracotomy or laparotomy should not be employed\r\n* Patients who will require biopsy should not be enrolled if in the opinion of the principal investigator, the tumor site places the patient at substantial risk from the biopsy procedure
Pre-surgery tumor deemed amenable to core biopsy (with at least 100 mm^3 tumor volume per biopsy)
Patients must be willing and able to undergo a pre-surgery biopsy and wait 2 weeks before their debulking surgery; NOTE: consented patients with subsequent inadequate biopsy material will not receive INCB024360 or be analyzed and will be replaced; the study will be stopped if adequate tissue is not obtained in more than 2/3 of paired samples with a maximum accrual of 18 patients
Patient must agree to allow 3 separate biopsies of any malignant lesion; biopsies do not need to be done if:\r\n* Tumor is not considered accessible by either the investigator or the person performing the biopsy (it is determined the risk is too high due to location near vital organs or too great of a risk of an adverse event)\r\n* Patient is on anticoagulation and it would be unsafe to temporarily hold the anticoagulation\r\n* Consent of the principal investigator (PI) not to have a biopsy done\r\n* A minimum of 8 subjects must participate in the biopsy part of the study
Presence of appropriate size and site of viable tumor tissue for safe tumor biopsy collection (the biopsy is optional and requirement is only applicable to subjects considered for the expansion cohort stage of the study)
Pathologic confirmation of DCIS of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration; patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study\r\n* Patients with microinvasion on diagnostic core biopsy, defined as tumor =< 1mm in greatest dimension, will be allowed to participate\r\n* All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatment
Endoscopy with biopsy
Diagnosis of liver confined hepatocellular carcinoma (HCC) confirmed by histology or American Association for the Study of Liver Diseases (AASLD) guidelines\r\n* Lesions < 1 cm in diameter have a low likelihood of being malignant and should be followed; lack of growth over 1-2 years suggests it is not HCC\r\n* Alpha-fetoprotein (AFP) > 200 and radiological evidence (arterial hypervascularity) of lesion > 2 cm does not require biopsy\r\n* Two imaging modalities (triphasic computed tomography [CT], MRI, ultrasound, angiography) demonstrating “arterial hypervascularity” in the background of cirrhosis does not require biopsy\r\n* One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy\r\n* Atypical appearances on imaging requires a biopsy\r\n* Non-conclusive biopsy requires closer monitoring \r\n* For non-cirrhotics (by biopsy or imaging findings), diagnosis of HCC requires biopsy
Patients enrolled at sites participating in the Repeat Biopsy Study must agree to submission of tissue obtained by a repeat biopsy performed at the time of disease progression
Tumors that are amenable to serial biopsy
Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of the most recent prior chemotherapy regimen) are required for all cohorts except glioblastoma
Biopsy confirmation of GVHD is not required. Enrollment should not be delayed for biopsy or pathology results unless local institutional practice mandates biopsy confirmation to make a GVHD treatment decision.
Provide a baseline tumor biopsy
Patients must have archived tumor specimens available unless pre-treatment biopsy is being performed; if pre-treatment biopsy is being performed, availability of archived specimen must still be assessed and collected if available
For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline; previously collected archival tissue will also be obtained on all participants; for participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) the archival tissue alone will be acceptable; tissue needs to be located and availability confirmed at time of registration; participants must agree to a mandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely accessible; for patients randomized to carboplatin alone who decide to crossover to nivolumab monotherapy at time of progression, a mandatory biopsy will be required, if tumor is safely accessible, prior to initiating nivolumab; participants must also agree to undergo this biopsy, if applicable
Tumor accessible for biopsy
Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ? 6 weeks and ? 6 months before treatment, or at the discretion of PI.
The subject is willing to undergo tumor biopsy during the Screening period, or if the tumor is inaccessible for biopsy, archived tumor material must be available for submission;
Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
Patients must have disease amenable to biopsy and must be willing to undergo a paired biopsy for correlative analyses (the first biopsy within 28 days prior to start of treatment and the second biopsy while on treatment)
All subjects in Cohort 3 or Phase 2 dose (P2D) must have a lesion accessible for FNA or core or open biopsy on day 8 of the first treatment cycle.
A tumor accessible for biopsies and consent to undergo tumor biopsies before and during MSC2363318A treatment. Subjects who do not have a tumor suitable for biopsy (such as, but not limited to, high procedural risk, inaccessible site for needle biopsy, etc.) but are otherwise eligible for this study may be considered for enrollment on a case-by-case basis after discussion with the Medical Monitor of the study
Patient has disease amenable to biopsy and is agreeable to undergo a biopsy; NOTE: under unusual circumstances, submission of ascites material may be acceptable if a biopsy is not possible; this exception will require approval by one of the study principal investigators
Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
Biopsies (DLBLC, MM): Diagnostic archival FFPE (either in tumor blocks or sectioned/mounted specimens) may be submitted in lieu of a pre-study research biopsy if it has been obtained no more than 1 year prior to enrollment and only after discussion with the Celgene Medical Monitor
A formalin-fixed, paraffin-embedded tumor block (or 16 unstained sections [charged, 4 um]) of the biopsy or curettage must be submitted along with the corresponding pathology report; patients without such material, but willing to undergo repeat biopsy or curettage, are eligible; repeat biopsy must occur after consent but prior to randomization
Diagnostic stereotactic biopsy: Patients diagnosed with DIPG may choose to have a stereotactic biopsy prior to starting radiation therapy.
A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory
Consent to paired tumor biopsy, for accessible tumors
Current treatment with warfarin; for patients not on an anti-platelet agent such as aspirin, other anticoagulation is acceptable so long as the treating physician feels that it is safe to hold it on the day of the biopsy until after the biopsy has been safely completed
Biopsy of a metastatic lesion is not required for protocol entry but all patients with reasonably accessible lesions (chest wall, breast, skin, subcutaneous, superficial lymph nodes, bones and liver metastases) must agree to biopsy (lung and brain metastasis will not be biopsied):\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons (i.e. is clinically indicated), and excess tissue that would otherwise have been discarded is then used for research purposes; if a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol\r\n* Patients with reasonably accessible lesions as described above, who will not agree with the biopsy, will not be enrolled in the trial\r\n* Patients with NO reasonably accessible lesions as described above can be enrolled in the trial
Agree to have prostate biopsy blocks provided to the study for evaluation
At least 1 lesion amenable for outpatient biopsies; this should be a cutaneous or palpable metastatic site or a deeper site accessible by image-guided biopsy that is deemed safe to access by the treating physicians and interventional radiologists; patients without accessible lesions for biopsy but with prior tissue available from metastatic disease would be eligible at the investigator’s discretion
At least 1 lesion amenable for outpatient biopsies; this should be a cutaneous or palpable metastatic site or deeper site accessible by image-guided biopsy that is deemed safe to access by the treating physicians and interventional radiologists; patients without accessible lesions for biopsy but with prior tissue available from metastatic disease would be eligible at the investigator's discretion
Patients enrolled in the expansion stages must agree to a tumor biopsy to be obtained during the screening period and during Cycle 2 or at the time of PD, if earlier. If a biopsy is deemed by the investigator to not be in the patient's best interest, prior approval must be obtained from the Medical Monitor to waive this requirement.
Patient must have a site of disease for biopsy, and be a candidate for tumor biopsy according to the institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study.
Patient must consent to allow for a baseline tumor biopsy. Tumor material from biopsies done before the screening period are acceptable if the biopsy was performed within 3 months prior to the planned treatment start and no other systemic cancer therapy was administered in the interim. If a biopsy is performed and the specimen is considered non-diagnostic or does not have enough tissue, this does not prevent the patient from proceeding with the treatment.
Patients must agree to pretreatment tumor biopsy
Willing to attempt a baseline tumor biopsy procedure
Any patient that has had a biopsy only or less than 25% of their tumor removed
Patients must all have available tumor tissue for biopsy and not have any bleeding diathesis and/or chronic anticoagulation that cannot be stopped for the biopsy
Mandatory diagnostic biopsy and whole blood sample are required. The tumor biopsy tissue will be analyzed for the presence of immune cells and will also undergo genomic, transcriptomic, and proteomic profiling.
Willingness to undergo research biopsy under the following circumstances:\r\n* Patients with “easily accessible disease”\r\n** Patients with skin or chest wall disease amenable to a punch biopsy under local anesthesia are required to undergo a baseline biopsy and a biopsy at the time of disease progression as part of this protocol\r\n** Patients with a breast mass or axillary lymph node amenable to an image-guided core biopsy are also required to undergo a baseline biopsy and a biopsy at the time of disease progression as part of this protocol\r\n** Patients with malignant ascites fluid or a malignant pleural effusion of sufficient volume to be amenable to tap (either in-office or image-guided) are also required to undergo a baseline tap and a tap at the time of disease progression as part of this protocol\r\n** Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n** Patients will be approached during cycle 1 about providing an optional tissue sample at that time; however, this biopsy will be optional\r\n* Patients with “accessible disease”\r\n** Patients with sites felt to be accessible to an image-guided or incisional biopsy in the opinion of the patient’s treating oncologist and physician performing the procedure, and not meeting the criteria for “easily accessible disease”, are required to undergo a baseline biopsy as part of this protocol; such sites may include, but are not limited to: liver, lymph nodes, soft tissue, lung, chest wall, and bone; cycle 1 biopsy and biopsy at time of disease progression are optional\r\n** Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n** If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons (i.e. is clinically indicated), and excess tissue that would otherwise have been discarded is then used for research purposes; if a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol\r\n** Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n** Some patients may have had a clinically indicated biopsy upon recent disease progression; no additional pre-treatment biopsy is required if that specimen can be used for the correlative studies described in this protocol\r\n** Patients will be approached at the time of progression about providing an optional tissue sample at that time; however, the time of progression biopsy will be optional\r\n* Other patients\r\n** Patients who do not have biopsy-accessible disease are not required to undergo a biopsy as part of study participation\r\n** In addition, patients who are being treated with therapeutic doses of anticoagulant(s), are not required to undergo a biopsy as part of study participation; if it is felt clinically appropriate despite anticoagulation (i.e. a skin punch biopsy, etc) by the treating physician, a biopsy is allowed, it is simply not required\r\n** The sites of metastatic disease and reason that the disease is not biopsy-accessible should be documented in the medical record and case report form(s)\r\n** Patients who do not undergo baseline biopsy must have their study participation approved by the overall principal investigator (PI) before start of protocol therapy; only patients who have biopsy inaccessible disease may enter the study without the requirement for baseline biopsy
Patient must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer or may undergo a repeat biopsy for histologic confirmation if pre-existing biopsy is not sufficient for diagnosis
Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
Patient has disease amenable to biopsy and is agreeable to undergo a biopsy; note: under unusual circumstances, submission of ascites material may be acceptable if a biopsy is not possible; this will require approval by one of the study principal investigators
Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained); prostate biopsy must be within seven months from screening; this includes prostate biopsy from men previously followed by active surveillance; less than 3 core biopsies is allowed if the patient has > 1 cm or T3 disease on magnetic resonance imaging (MRI)
FOR EXPANSION PHASE ONLY: Lack of accessible tumor for biopsy
The patient has biopsy-accessible tumor; for patients who had no prior anticancer therapy and had surgical resection within a year and tumor tissue is immediately available, that tumor will be analyzed and no biopsy will be needed
Patients must agree to undergo two research biopsies of a malignant lesion; patients may be exempt from biopsy if 1) the investigator or person performing the biopsy judges that no tumor is accessible for biopsy, 2) the investigator or person performing the biopsy feels that the biopsy poses too great of a risk to the patient, or 3) the patient’s platelet count is < 100,000/mcl or he/she cannot be safely removed from anti-coagulation therapy (if the anti-coagulation therapy needs to be temporarily held for the biopsy procedure); if the only tumor accessible for biopsy is also the only lesion that can be used for RECIST v1.1 response evaluation, then the patient may be exempt from biopsy; the goal will be to have a minimum of 3 patients undergo one or both of these research biopsies; accrual may be limited only to subjects whose tumor is safely accessible for biopsy to ensure the accrual goal for research biopsies described above is met (e.g., if 7 of 10 patients are accrued without any biopsies having been obtained, then all subsequent subjects who are registered must qualify for attempted research biopsy in order to be enrolled)
Patients must agree to undergo biopsy of a malignant lesion; biopsies do not need to be done if either the investigator or person performing the biopsy judges that no tumor is accessible for biopsy or that biopsy poses too great of a risk to the patient; patients may also be exempt if frozen tumor tissue has been collected within 12 months of study enrollment that the principal investigator deems is appropriate/sufficient for analysis on this protocol
Agree to undergo a biopsy of at least one metastatic site for RB status evaluation; adequate metastatic tissue from prior biopsy/resection can be used if available in lieu of a biopsy
Patient should agree to a tumor biopsy prior to protocol enrollment; post therapy biopsy is optional
Patients must consent to both a pretreatment and a post-treatment mandatory research biopsy prior to enrolling on trial, and therefore, must have tissue (excluding bone or brain) that is amenable to biopsy
Patients must have histologically proven stage IIIB, IV or recurrent non-small cell lung cancer; patients must be willing to undergo a pre-treatment tumor biopsy, either core needle biopsy or equivalent amount or via excisional specimen (cytology specimen not acceptable for this purpose)
Patients must have disease amenable to biopsy at the time of enrollment as biopsies are required for study participation
All patients with disease technically amenable to biopsy will be asked to undergo a biopsy; patient must agree to allow 2 biopsies of any malignant lesion that can be accessed by endoscopy or with the aid or radiology (i.e. CT guided)
For the phase 2 portion of the study; patients must have willingness to undergo research biopsy under the following circumstances:\r\n* Patients with “easily accessible disease”\r\n** Patients with skin or chest wall disease amenable to a punch biopsy under local anesthesia are required to undergo a baseline biopsy as part of this protocol\r\n** Patients with a breast mass or axillary lymph node amenable to an image-guided core biopsy are also required to undergo a baseline biopsy as part of this protocol\r\n** Patients with malignant ascites fluid or a malignant pleural effusion of sufficient volume to be amenable to tap (either in-office or image-guided) are also required to undergo a baseline biopsy as part of this protocol\r\n** Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n** Patients will be approached at the time of progression about providing an optional tissue sample at that time; however, the time of progression biopsy is optional\r\n* Patients with “accessible disease”\r\n** Patients with sites felt to be accessible to an image-guided or incisional biopsy in the opinion of the patient’s treating oncologist and physician performing the procedure, and not meeting the criteria for “easily accessible disease” are required to undergo a baseline biopsy as part of this protocol; such sites may include, but are not limited to: liver, lymph nodes, soft tissue, lung, chest wall, and bone; biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n** If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons (i.e. is clinically indicated), and excess tissue that would otherwise have been discarded is then used for research purposes; if a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol\r\n** Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n** Some patients may have had a clinically indicated biopsy upon recent disease progression and agreed to submit tissue to their institution’s frozen tumor bank; if the tissue was processed as specified in this protocol, no additional pre-treatment biopsy is required, particularly if that specimen can be used for the correlative studies described in this protocol\r\n** Patients will be approached at the time of progression about providing an optional tissue sample at that time; however, the time of progression biopsy will be optional\r\n* Other patients\r\n** Patients who do not have biopsy-accessible disease according to above are not required to undergo a biopsy as part of study participation\r\n** In addition, patients who are being treated with therapeutic doses of anticoagulant(s), are not required to undergo a biopsy as part of study participation; if it is felt clinically appropriate despite anticoagulation (i.e. a skin punch biopsy, etc) by the treating physician, a biopsy is allowed, it is simply not required\r\n** The sites of metastatic disease and reason that the disease is not biopsy accessible should be documented in the medical record and case report form(s)\r\n** Patients who do not undergo baseline biopsy must have their study participation approved by the overall principal investigator (PI) before start of protocol therapy
Patients must have available and be willing to submit baseline tissue taken at the time of disease progression to prior BRAF inhibitor-based therapy (either fresh frozen [preferred], or paraffin-embedded tumor blocks) OR must have a site of disease that can be biopsied within this study for translational medicine studies; tissue may be from an archival biopsy or a new biopsy after the patient has been registered to the protocol; since patients are referred to this protocol after progression on prior BRAF inhibitor-based therapy, the biopsy taken at the time of progression will be used as the baseline biopsy for this study; patients must be willing to submit plasma and whole blood for translational medicine studies
Histological or cytological documentation of solid tumors for whom single agent irinotecan is recommended; biopsy of primary tumor alone is adequate if the patient has clear evidence of metastatic disease and/or elevated carcinoembryonic antigen (CEA) and the treating physician does not feel biopsy of metastatic disease is clinically warranted
Agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers; the biopsy prior to taxol #1 is optional
Histological documentation of adenocarcinoma of the prostate, with available biopsy pathology; biopsy material must be available for pathologic review
Mandatory tumor biopsy/biopsies in accessible tumors; the determination of accessibility for biopsy is to be done by the ear, nose and throat (ENT) surgeon on examination and/or review of trans-sectional imaging: mandatory tumor biopsies (1st and 2nd biopsy; 3rd biopsy is optional)\r\n* For inaccessible tumors availability of tissue is required: >= 10 tumor containing formalin-fixed paraffin-embedded (FFPE) slides/sections; 12-18 ideal
Willingness to undergo a research biopsy of the affected breast\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* If a biopsy requires general anesthesia, then it is not allowed on this protocol\r\n* Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n* Some patients may have had a clinically indicated biopsy upon recent disease progression and agreed to submit tissue to their institution’s frozen tumor bank; if the tissue was processed as specified in this protocol, no additional pre-treatment biopsy is required as that specimen can be used for the purposes of participation in this clinical trial
Candidate for and willingness to have a surgically placed intraperitoneal catheter and tissue acquisition at the time of port placement; note: if an intraperitoneal catheter is already in place, a tumor biopsy will still be required; a guided core-needle biopsy is sufficient in these cases
Pre-treatment fresh core, excision or punch tumor biopsy
Disease location amenable to biopsy in outpatient clinical setting or operative biopsy within routine accepted schedule and practice of clinical care
Patients must be willing to consent to tumor biopsy for research purposes
Participants are not required to have measurable disease but must have an accessible tumor to biopsy
Patients who have already undergone excisional biopsy for qualifying DCIS
Biopsy confirmed malignancy of the gynecologic tract
Disease amenable to core biopsy; patients with pulmonary metastases as their only site of disease may enroll on this trial and will not undergo biopsy
For patients with biopsy-accessible disease, patients must be willing to undergo a required on-treatment research biopsy; this biopsy will occur on cycle 2 day 9;\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* Research biopsies requiring general anesthesia are not allowed on this protocol unless a biopsy is being obtained simultaneously for clinical reasons, in the judgment of the patients’ treating physician\r\n* Patients who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to continue protocol therapy; they will not be required to undergo a repeat biopsy attempt
Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone
Biopsy accessible tumor deposits
Positive serum anti-poliovirus titer prior to biopsy (except for retreatment)
Hemoglobin >= 9 prior to biopsy
Duodenal cancer on biopsy.
Consent to biopsy of tumor
Interval >= 4 weeks between open brain biopsy and initiation of protocol-based therapy
Biopsy-proven relapsed or refractory non-Hodgkin lymphoma requiring treatment, who have failed, unable to tolerate, or refused other available active therapies; patients should not have other treatment options considered curative (NOTE: for patients with lymphoma without central nervous system [CNS] involvement, a re-biopsy is necessary unless the patient has had a previous biopsy =< 6 months prior to treatment on this protocol if there has been no intervening treatment; patients with biopsy-proven CNS lymphoma at any time are not required to have a re-biopsy to be eligible for this study); NOTE: relapsed NHL is defined as NHL that relapses after at least one prior therapy and does not have available curative therapy; refractory NHL is defined as NHL that has progressed or not responded to most recent therapy and has had at least one prior therapy and have no available curative therapies
The subject has biopsy accessible tumor and is willing to undergo biopsy prior to planned protocol treatment
Patients must have an intact primary (not recurrent) invasive carcinoma of the breast; biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast
Patients must agree to undergo two research biopsies of (a) malignant lesion(s); tumor tissue obtained prior to study consent or treatment as part of standard care can also be submitted in lieu of performance of the first pre-treatment biopsy, if the principal investigator deems it to be of sufficient quantity/quality/timeliness; patients may be exempt from biopsy if 1) the investigator or person performing the biopsy judges that no tumor is accessible for biopsy, 2) the investigator or person performing the biopsy feels that the biopsy poses too great of a risk to the patient, or 3) the patient's platelet count is < 100,000/mcl or he/she cannot be safely removed from anti-coagulation therapy (if the anti-coagulation therapy needs to be temporarily held for the biopsy procedure); if the only tumor accessible for biopsy is also the only lesion that can be used for RECIST v1.1 response evaluation, then the patient may be exempt from biopsy; if the investigator deems a second research biopsy to be high risk after a patient has completed the first research biopsy, the patient may be exempt from the second biopsy
Patient must agree to allow 2 separate biopsies of any malignant lesion; biopsies do not need to be done if:\r\n* Tumor is not considered accessible by either the investigator or the person performing the biopsy (it is determined the risk is too high due to location near vital organs or too great of a risk of an adverse event)\r\n* Patient is on anticoagulation and it would be unsafe to temporarily hold the anticoagulation\r\n* Consent of the principal investigator (PI) not to have a biopsy done
(For expansion cohort only): Tissue must be available to confirm positive expression of AG7 antigen, defined as proportional score ?2, via slides or tumor block from either original diagnostic biopsy material or biopsy of relapsed disease
MRI and chest x-ray within 6 weeks prior to pre-registration; a postoperative MRI is required for all patients who underwent open biopsy, or resection, but is not mandatory following stereotactic biopsy
Patient must be at least two weeks post any brain surgery (whether stereotactic biopsy, open biopsy or resection) at the time of randomization
Willing to undergo or must have had a lower GI biopsy within 7 days of informed consent to confirm GI GvHD. Biopsy results are not needed to initiate treatment; however, if biopsy results are not consistent with aGvHD, treatment with GLASSIA will be discontinued.
For Phase 2, has archived or fresh tumor biopsy samples (obtained during screening) sufficient for genotyping.
Patients must have agreed to a new biopsy of tumor (deemed accessible and safe for biopsy by the investigator's assessment) and allowing acquired tissue to be used for biomarker analysis. If the biopsied lesions were previously irradiated, they must demonstrate either radiographic or pathological evidence of recurrent or residual disease.
Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study
Willingness to provide consent for biopsy samples
Biopsy-confirmed histopathological diagnosis of FL. Biopsy specimen should be obtained ?2 years prior to randomization, unless medically contraindicated
Patients must have disease amenable to biopsy and must be medically fit to undergo a biopsy
Men with metastatic castration-resistant prostate cancer (mCRPC), with accessible metastatic soft-tissue lesions for tumor biopsy
>= 3 positive cores within diagnostic biopsy specimens
Patients must have histologically or cytologically proven non-small cell lung cancer; tumor tissue must be available from all patients prior to initiation of protocol therapy, either from original diagnostic biopsy, or biopsy performed prior to initiation of protocol therapy
Subjects must have at least one tumor lesion that is suitable for repeat biopsy, and must agree to two tumor biopsies (pre- and post- treatment).
Disease amenable to biopsy and agree to undergo biopsy for molecular analysis
If an open biopsy is performed, the patient must be at least one week post biopsy; this requirement does not apply to patients who undergo stereotactic biopsies
Has a core or excisional baseline tumor biopsy specimen available or willingness to undergo a pre study treatment tumor biopsy to obtain the specimen.
The subject has a tumor suitable for biopsy and is willing to undergo tumor biopsy, preferably of the primary tumor, within 28 days prior to Cycle 1/Visit Day 1;
At least 25% of cells >= 1+ for FRa staining based on diagnostic (i.e., prior to NAC) tumor biopsy
Ability to comply with the collection of tumor biopsies; tumors accessible for biopsy
Biopsy accessible tumor deposits
At least one tumor amenable to excisional, core or forceps (transbronchial) biopsy; patients must be willing to undergo tumor biopsies before starting therapy and after the third (3rd) CDX-1401 injection; additionally, the first 12 patients enrolled must consent to a third tumor biopsy to be performed after the 3rd MPDL3280A infusion
Patient must have a biopsy-accessible tumor to be radiated
Tumor tissue submitted for molecular and genetic analysis through the companion Stand-up 2 Cancer (SU2C) radiologically guided biopsy of abiraterone and/or enzalutamide refractory mCRPC protocol\r\n* Patients who consent to participate in the companion biopsy protocol and are subsequently determined to be ineligible for biopsy are eligible to participate in the current protocol
Patients must have tumor accessible by interventional radiology or surgical intervention and suitable for biopsy with 5-6 passes of a 16 or 18 gauge needle for core biopsy (defined as at least 1 cm^3 tumor/50 mg accessible for biopsy), and must agree to undergo up to two surgical resections/biopsies to collect tumor for research purposes; the first of these biopsies will occur at the beginning of the study, prior to genetic analysis and treatment; the second biopsy will be performed at the time of disease progression/end of study should funding be available
Accessible tumor for biopsy and willingness to provide pre-dose tumor biopsies on Days 1 and Day 15.
An adequate tumor specimen obtained by either excisional biopsy, incisional biopsy or core needle biopsy must be sent to the central pathology lab for evaluation. The material must measure at least 0.8 × 0.1 cm in size or contain at least 50 tumor cells.
Excisional biopsy
Arm 2 only: At least 1 tumor that is amenable to biopsy, as determined by the investigator, and participant must be willing to undergo a biopsy prior to and at least once following anti-macrophage migration inhibitory factor (anti-MIF) antibody treatment
Patients must allow biopsy at the time of fiducial placement
Adequate diagnostic prostate core biopsy specimen for pharmacodynamics evaluation (tissue block, or at least 15 unstained sections), or willingness to consent to and undergo a pretreatment ultrasound-guided biopsy of the prostate
Willingness to consent to research biopsy
Participants must have accessible lesion(s) that permit a total of two to three biopsies (pretreatment and on-treatment) or one biopsy (on-treatment, if archival tissue can be submitted in place of a pre-treatment biopsy) without unacceptable risk of a significant procedural complication. RECIST lesions should not be biopsied.
The presence of metastatic disease amenable to computed tomography (CT) or ultrasound guided biopsy; this may include thoracolumbar vertebral bodies, pelvis, femur or humerus, or soft tissue or nodal metastasis amenable to biopsy (excluding lung or pleural lesions)
Biopsy accessible tumor (may be waived under certain circumstances)
Willing to take drug during the 2-12 weeks between biopsy and surgical removal of BCC
HER2 0 or 3+ by IHC on pre-treatment biopsy of metastatic lesion (if performed)
No prior treatment (patients on \watch and wait\ may enter the study if a recent biopsy [obtained within the last 6 months] is available)
Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator
Patients must have biopsy accessible disease and must be willing and able to undergo a biopsy
Phase II: The initial 20 patients must have evaluable baseline tumor samples; evaluable samples are defined as those obtained by core biopsy or surgical resection and amendable to histological analysis; samples obtained by fine needle aspiration biopsy are not considered evaluable; patients who do not have evaluable archival tumor samples must consent to a tumor core biopsy prior to starting study treatment and, patients who consent to the baseline tumor biopsy will be eligible to receive study treatment irrespective of whether the samples obtained are evaluable
The biopsy confirming diagnosis can be up to 12 weeks prior to registration as long as there is no intervening therapy; note: if patient has had lymphoma treatment since previous biopsy, a biopsy should be repeated
Has ?20% of cancer in any biopsy core,
Has ? 7 mm of cancer in any biopsy core,
Has ? 33% positive biopsy cores
Woman histologically diagnosed by an open biopsy procedure
Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy. If an excisional or incisional biopsy has been performed, participants remain eligible for the study provided the residual disease meets the staging criteria required for the trial (e.g., excisional biopsy of a lymph node with residual T4 primary). Prior surgical debulking, including tonsillectomy, for the head and neck cancer under study is not allowed.
All participants must provide tumor tissue from the primary or metastatic tumor site obtained from a prior or new biopsy or surgical procedure for detection of PIK3CA mutation by central laboratory test. Confirmation of adequate tissue is required prior to enrollment. For participants enrolled to biopsy cohorts or who consent to optional tumor biopsies, the pretreatment tumor biopsy may be used
Must have 3 core biopsies involved with cancer; prostate biopsy must be within seven months from screening; less than 3 core biopsies is allowed if the patient has > 1 cm or T3 disease on MRI
Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening
All subjects must have a fresh tumor biopsy
Agree to undergo a pre-treatment and on treatment biopsy and have disease amenable to biopsy required in PK/pharmacodynamic dose expansion cohorts.
Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/baseline, and during therapy on the study.
Patient must have an accessible non-bone tumor lesion from which serial core biopsy specimen can be obtained; NOTE: if baseline biopsy is attempted and is unsuccessful (e.g., patient intolerance, inadequate tissue), the patient will still be considered eligible for the study; if core biopsy is not possible, other methods may be approved in advance by the protocol chair/designee
If an open biopsy is performed, the patient must be at least one week post biopsy; this requirement does not apply to patients who undergo stereotactic biopsies
Patients with suspected but no biopsy confirmed BE
Recommendation for biopsy will result from an imaging work-up originating with a screening exam (mammogram, tomosynthesis, ultrasound, or MRI) that was within 3 months of biopsy
Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2-year imaging follow-up is not available
Women who have a core biopsy or excisional biopsy containing invasive cancer
Biopsy-proven (consisting of >= 10 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core, either random or targeted, in the most recent biopsy\r\n* All prior biopsies must meet the following: =< 50% of the total number of random biopsy cores positive for cancer\r\n* Gleason score =< (3+4)
No planned prostate biopsies during the intervention until after the post-intervention biopsy
Histologically confirmed, positive HSIL of CIN2+ or higher (only CIN2+/3 subjects will be selected) cervical biopsy, confirmed by external (independent) pathologist panel within the 12 weeks prior to enrollment. If the standard care biopsy is not available for evaluation by the independent pathologist, a fresh biopsy and endocervical curettage will be required. The extent of colposcopic HSIL disease should not involve more than two quadrants of the cervix. Biopsies should be taken from each affected quadrant
Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or biopsy) preferably within 12 months from the start of treatment; should the imaging or biopsy be performed outside this window it will be up to the physician's discretion to re-scan/biopsy
The presence of atypical ductal hyperplasia (ADH) on core biopsy
Inability to obtain a biopsy of the tumor as deemed by the study interventional radiologist
Subjects may be enrolled at one of three time points in the clinical course of disease:\r\n* Study 1 (New Diagnosis): \r\n** Pediatric patients with newly diagnosed primary central nervous system tumors undergoing surgical resection/biopsy within 21 days or who, within the prior 21 days, have undergone resection/biopsy with substantial residual (greater than half as assessed by the surgeon) tumor\r\n* Study 2 (Possible Tumor Recurrence): \r\n** Pediatric patients with a history of treated primary central nervous system tumor, in whom standard imaging has raised concern for tumor recurrence; tumor tissue for histological analysis must be available from a biopsy/resection planned within the next 21 days or from a prior resection/biopsy if no current biopsy material is available\r\n* Study 3 (Response to Therapy): \r\n** Pediatric patients with a primary central nervous system tumor who will be starting a new regimen (standard or experimental) of chemotherapy within 21 days, have not received radiation therapy during the past six months, and who will not be receiving radiation therapy during the first two cycles of chemotherapy
Tumor site amenable to MRI guided biopsy as determined by the radiologist
Scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy
Patients who have biopsy confirmed multi-centric disease
For patients who undergo optional metastatic tumor biopsy following completion of gallium citrate PET:\r\n* Presence of one or more metastases by standard radiographic scans including cross-sectional imaging of the chest/abdomen/pelvis and whole body bone scan that is safely accessible to tumor biopsy in the judgment of treating clinician and/or interventional radiology\r\n* No history of radiation therapy to the target metastatic lesion selected for tumor biopsy\r\n* No contra-indication to biopsy including uncontrolled bleeding diathesis\r\n* Platelets > 75,000/ul\r\n* Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) =< 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy
Patients who have biopsy confirmed multi-centric disease
Patients with peripheral lung lesions 1-5 cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy; the decision to pursue biopsy will be made by the treating physician and agreed upon by the patient
Patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project
SUB-STUDY I: Prostate biopsy histology grade >= Gleason 6, positive biopsy > 2 cores
SUB-STUDY I: At least 7 days after most recent prostate biopsy
Be willing to undergo fresh tumor tissue biopsy of an accessible tumor lesion prior to pembrolizumab; a mandatory fresh biopsy will be collected following C11-AMT PET imaging; subjects for whom fresh samples cannot be provided (e.g. inaccessible or subject safety concern) or do not agree to this fresh tumor research biopsy of accessible tumor will be deemed ineligible for study participation; exception to the mandatory tumor tissue collection are patients with metastatic lung lesions as the only site of metastatic disease; fresh biopsy collection from these subjects will be optional, due to high risk of pneumothorax
Biopsy or resection of the primary tumor within 14 days the first injection of [18F]F-AraG
For patients undergoing optional tumor biopsy:\r\n* No history of bleeding diathesis\r\n* Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy
Biopsy-proven adenocarcinoma of the prostate; biopsy may be performed outside of University of California San Francisco (UCSF), if detailed results of sextant biopsy are available; a minimum of 20 patients out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy
Pre-enrollment prostate biopsy must consist of at least 8 cores
Biopsy reviewed by a University of Miami pathologist
Requirement for medications, which interfere with platelet function, such as aspirin, which cannot be stopped within 1 week prior to the biopsy (applicable only to patients undergoing biopsy)
Patients must have high-risk neuroblastoma with at least ONE of the following:\r\n* Recurrent/progressive disease at any time; biopsy is not required, even if there is a partial response to intervening therapy\r\n* Refractory disease (i.e. less than a partial response to frontline therapy, including a minimum of 4 cycles of chemotherapy); no biopsy is required for eligibility for this study
An interval of > 6 weeks between the biopsy and MRSI
Prostate biopsy-naive or a single negative biopsy
Have received recommendation for and are scheduled for an ultrasound guided FNAB, ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy of at least one thyroid nodule.
Abnormal uptake in prostate necessitating biopsy
Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation)
No evidence on biopsy of extracapsular extension
Prostate biopsy within 6 weeks (unless biopsy is planned from extraprostatic tissue)
PRE-ENROLLMENT BIOPSY PARAMETERS: minimum of 12 biopsy cores
FINAL ENROLLMENT BIOPSY PARAMETERS: 12 standard biopsy cores plus targeted regions based upon MRI
Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained prior to initiation of chemotherapy; it should be performed within 28 days prior to enrollment (patients with a biopsy of recurrent disease that is HER2-positive and have not received HER2-directed therapy since the biopsy can exceed the 28-day window up to 6 months); patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
Planned procedures or therapies in between SOC scans and study scan on s-DCT, e.g., biopsy or excision of lung lesion
Sufficient fresh or frozen tissue remaining from pre-treatment core biopsy/incisional biopsy or willing to undergo biopsy (at University of North Carolina [UNC] via LCCC9819) for research purposes only (approximately 10 mg or one core's worth of tissue needed)
Is willing to provide archival tumor tissue from a biopsy performed within 6 months of progression during treatment with erlotinib, gefitinib, afatinib, or osimertinib OR has at least one lesion, not previously irradiated, amenable to core biopsy and is willing to undergo screening tumor biopsy
The first 15 patients with adenocarcinoma will be offered an optional tumor biopsy (typically EGD biopsy) at 8 weeks; starting with adenocarcinoma patient #16, patients must have an accessible tumor and must agree to tumor biopsy at 8 weeks; this will continue to be mandatory until a total of 20 patients have undergone biopsy at 8 weeks
Patients with peripheral lung lesions 1-7 cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy; the decision to pursue biopsy will be made by the treating physician and agreed upon by the patient
Received a prostate biopsy procedure within 30 days before admission into the study
Have had stereotactic or ultrasound-guided biopsy with marker placement
Men who have elected to proceed with a diagnostic prostate biopsy
A superficial tumor easily and safely accessible for a research biopsy or are being considered for resection or biopsy of their tumor as part of standard of care and have recent pathology
Patients with lesions safely accessible for protocol driven biopsy
Tumor accessible to biopsy
Sufficient fresh or frozen tissue remaining from pre-treatment core biopsy/incisional biopsy or willing to undergo biopsy for research purposes only (approximately 10mg or one core’s worth of tissue needed)
All male patients (all ages) scheduled for standard prostate needle biopsy (first, repeat or active surveillance biopsy) under local anesthesia will be eligible for the study.
The patient must have one negative cystoscopy 3 months following most recent biopsy
Lack of archive tumor tissue from a biopsy or surgical resection of a metastatic lesion done within 4 months of study enrollment. Patients will be given an option to have a repeated biopsy of a metastatic lesion if they had a diagnostic tumor biopsy intended for use in the current study that was performed more than 4 months prior to analysis, or there is insufficient tissue from the initial biopsy to complete the analysis, as long as they have not started treatment with a CDK 4/6 inhibitor. Otherwise, the patient will be excluded from the study participation.
Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
For TAK-580 + nivolumab and TAK-202 (plozalizumab) + nivolumab only: Had disease accessible for repeat nonsignificant risk biopsy (those occurring outside the brain, lung/mediastinum, and pancreas, or obtained with endoscopic procedures extending beyond the esophagus, stomach, or bowel) and willingness to undergo serial tumor biopsies.
For Concomitant Treatment: Prior tumor resection or biopsy up to 8 weeks prior to first MRZ dose
Safely accessible tumor lesions (based on investigator's assessment) for serial pre treatment and post treatment biopsies are required for participants receiving TAK-659 monotherapy run-in treatment for 2 weeks followed by TAK-659 plus nivolumab combination treatment [ approximately 10/30 response-evaluable participants]; adequate, newly obtained, core or excisional biopsy of a metastatic tumor lesion not previously irradiated is required. Mandatory biopsies will be taken before TAK-659 monotherapy, after the 2 weeks of TAK-659 monotherapy, and after 6 weeks of TAK-659 plus nivolumab combination therapy. An optional biopsy may be taken at PD with additional consent from the participants.
Safely accessible tumor lesions (based on investigator's assessment) for serial pretreatment and posttreatment biopsies are required for participants receiving TAK-659 monotherapy run-in treatment for 2 weeks followed by TAK-659 plus nivolumab combination treatment (approximately10/30 response-evaluable participants); adequate, newly obtained, core or excisional biopsy of a metastatic tumor lesion not previously irradiated is required. Mandatory biopsies will be taken before TAK-659 monotherapy, after the 2 weeks of TAK-659 monotherapy, and after 6 weeks of TAK-659 plus nivolumab combination therapy. An optional biopsy may be taken at progression with additional consent from the participants.
Safely accessible tumor lesions (based on investigator's assessment) for serial pretreatment and posttreatment biopsies are required for participants receiving TAK-659 monotherapy run-in treatment for 2 weeks followed by TAK-659 plus nivolumab combination treatment (approximately 10/30 response-evaluable participants); adequate, newly obtained, core or excisional biopsy of a metastatic tumor lesion not previously irradiated is required. Mandatory biopsies will be taken before TAK-659 monotherapy, after the 2 weeks of TAK-659 monotherapy, and TAK-659 after 6 weeks of TAK-659 plus nivolumab combination therapy. An optional biopsy may be taken at progression with additional consent from the participants.
Agreeable and clinically feasible pre-treatment biopsy
Histologic documentation: pathologic confirmation of invasive breast cancer by core or surgical biopsy (fine-needle aspiration [FNA] alone is not adequate)
Axillary lymph node positive breast cancer (fine needle aspiration [FNA] not required)
Diagnosis confirmed on core needle, vacuum-assisted or surgery ? 90 days of registration
Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
Surgical axillary staging procedure prior to study entry; Note: fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted
Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
Pathologic confirmation of metastatic breast cancer diagnosed by core needle biopsy
Availability of archival or fresh tumor specimen that is suitable for analysis. Acceptable samples must have been acquired using core needle biopsy or excisional biopsy. Samples that were acquired using fine needle aspiration are not acceptable.
Patients must have an adequate tumor tissue sample prior to enrollment available for correlative studies as defined below: core needle biopsy or incisional biopsy samples that can provide >= 5 unstained sections of 5 micron thickness; fine needle aspiration (FNA) sample alone is not sufficient
Sufficient tissue from diagnostic tumor/ lymph node biopsy (from within 2 months prior to ICF signature) must be available for translational research purposes or subject is willing to undergo core needle or incisional/ excisional biopsy during Screening.
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
Nodal status - positive (FNA or core biopsy of the node[s] is cytologically or histologically suspicious or positive; Imaging is suspicious or abnormal but FNA or core biopsy was not performed.)
The subject is willing to undergo a core needle biopsy during screening and during Cycle 2, Study Week 5. Archival tumor samples are requested, but are not required for eligibility.
Approximately 1 cm3 preferred but 1 mg minimum of accessible and dispensable tumor (minimum of 3 passes with a core needle)
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration;\r\n* High-grade neuroendocrine carcinoma or combined SCLC and non-small cell lung cancer (NSCLC) is permitted
Archival tumor sample available; tissue from an fine-needle aspiration (FNA) is allowed but tumor tissue from a core needle biopsy is preferred
Patients’ melanoma must be positive for both tyrosinase and human leukocyte antigen (HLA)-A2 per Loyola University Medical Center pathologic review from fine needle aspiration (FNA)/core/excisional biopsy of lesion
Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to starting treatment; central venous catheter placements are permitted
Be willing to provide tissue from an on-treatment fine-needle aspiration (FNA) or core biopsy of a tumor lesion; subjects must consent to on-treatment biopsy prior to initiation of clinical trial, however in subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may still continue on study
Patients must have non-target lesion accessible for sequential biopsy (core needle biopsy or excision preferred, fine needle aspiration not eligible)
STUDY TREATMENT: An adequate pre-treatment tumor biopsy is required to confirm histologic diagnosis. Acceptable options include laparoscopic biopsy or image-guided core needle biopsy (minimum of two cores). Fine needle aspiration (FNA) biopsy or cytology from ascites is not adequate.
Liver lesion safely amenable to core needle biopsy.
Willing to undergo core needle biopsy of liver metastatic site.
Subject entering the study will need to consent for mandatory biopsy at study entrance and as an optional procedure prior to C3 for biomarker evaluation. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient.
Institutional confirmation of pathology on core biopsy (not cytology or fine needle aspiration) or laparoscopic biopsy performed at Memorial Sloan Kettering Cancer Center (MSKCC) with sufficient tissue for analysis, and willingness to undergo repeat biopsy if diagnostic biopsy was performed at an outside hospital
Fine needle aspirate within 3 days prior to study drug administration.
Minor surgical procedures, fine needle aspirations or core biopsies within 3 days prior to enrollment date. Bone marrow aspiration and/or biopsy are allowed.
Have at least one metastatic lesion amendable for biopsy (core, punch, or fine needle aspiration [FNA])
The patient has a pathologic diagnosis of tumor biopsy or fine needle aspiration (FNA) of esophageal or gastric cancer of adenocarcinoma histology
Willing to undergo a core needle or excisional biopsy on-treatment; subjects will be assessed at the time of biopsy for safety of undergoing the procedure
Subject willing to undergo biopsy prior to treatment with investigational therapy for fresh tissue immune cell analysis and would consider biopsy at disease progression (progression biopsy is not mandated); biopsy should be obtained with core needle; fine needle aspirates are not sufficient; if prior archival tissue is available, it should be submitted
Must agree to a fresh core or excisional biopsy from a metastatic site within a 12-week window prior to enrollment; if such a biopsy is already available, cell blocks must be provided; (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission); specimens from the nephrectomy and fresh biopsy must be received and assessed for adequacy of tissue by the Data Coordinating Center (DCC) (University of Southern California [USC]) prior to randomization
Consent to undergo a mandatory baseline biopsy of a metastatic tumor, if clinically feasible and safe to perform; acceptable samples include core needle biopsies of bone or lymph node; at least three cores should be obtained; a fine needle aspirate is not acceptable; subjects have the option of consenting to a repeat biopsy at time of progression
Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality.
Cohort B will enroll 20 patients with a diagnosis of follicular lymphoma, grade 1-2 and 3A; grade 3B is excluded; diagnoses made by a fine needle aspirate or bone marrow biopsy alone are not permitted
Invasive adenocarcinoma of the breast diagnosed by core needle biopsy
Ipsilateral axillary lymph nodes must be evaluated by MRI or ultrasound within 12 weeks prior to study registration to determine clinical nodal status; if imaging is suspicious or abnormal, a fine needle aspiration (FNA) or core biopsy of the questionable node(s) on imaging is required; nodal status should be classified according to the following criteria:\r\n* Nodal status – negative\r\n** Imaging of the axilla is negative; OR\r\n** Imaging of the axilla is suspicious or abnormal AND FNA or core biopsy is negative\r\n* Nodal status – positive\r\n** FNA or core biopsy of node(s) is cytologically or histologically suspicious or positive
Patients must have histologically confirmed invasive breast cancer (stages I-III) who have undergone core needle biopsy (clinically or radiographically at least T1c to allow adequate residual cancer tissue at surgery) and will be scheduled for surgical resection (i.e. segmental excision or mastectomy)
Fine-needle aspiration (FNA) evidence of squamous cell carcinoma involving 3 or more lymph nodes
Low tumor burden with at least one lesion that is suitable for image-guided intratumoral injection and needle biopsy.
Histologic documentation of breast cancer by core needle or incisional biopsy
Core needle biopsy or surgical specimen that confirms ICC; patients must be determined to be unresectable by a multidisciplinary team that includes a hepatobiliary surgeon
Patient will have a tumor suitable for fine needle aspirates (FNA) or core biopsy for research purposes (2 or more FNAs if core is not feasible)
Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
Fine needle aspirate within 3 days prior to study drug administration
DCIS with microinvasion on histology on core needle biopsy
Histological diagnosis must be based on surgical or core biopsy not just fine needle aspiration. Biopsies performed at other institutions must undergo pathology review and confirmation at MD Anderson Cancer Center.
Biopsy-accessible breast tumor of significant size for core needle biopsy (>= 2cm)
Have at least 1 of the tumor sites that must be amenable to core needle biopsy and this may not be the site of disease used to measure antitumor response
A tumor lesion that can be readily biopsied using a core needle via clinical exam or imaging-guidance
Newly diagnosed and histopathologically confirmed (by central pathology review) potentially resectable soft tissue sarcomas of the extremity and trunk of the following subtypes: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and undifferentiated pleomorphic sarcoma\r\n* An incisional or core biopsy is the preferred method for diagnosis; fine needle aspiration is not acceptable\r\n* Sites permissible for biopsy include\r\n** Extremities: upper (including shoulder) and lower (including hip)\r\n** Trunk: body wall
Subjects must be willing to undergo 2 sets of core needle biopsies (pre-treatment and on-treatment), if there are lesions amenable to biopsy; an optional core biopsy will be requested at progression
Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by needle core biopsy; fine-needle aspiration is not sufficient; incisional/excisional biopsy is not allowed; in case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint
MANDATORY biopsy after registration and prior to cycle 1 day 1 (C1D1) treatment: Primary tumor or a metastatic lesion must be amenable to biopsy after registration and prior to C1D1 treatment for PD-L1 status and other correlative studies. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is allowed as long as there is sufficient cellularity. Sample requirement is formalin-fixed paraffin-embedded (FFPE) block + 2 H&E stained slides or 17 unstained slides + 1 H&E stained slide.
Female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)
Pathologic documentation of invasive breast cancer by biopsy (fine needle aspiration [FNA] alone is not adequate)
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy
Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or magnetic resonance imaging [MRI]) within 6 weeks prior to randomization; if suspicious or abnormal, fine needle aspirate (FNA) or core biopsy is recommended, also within 6 weeks prior to randomization; findings of these evaluations will be used to determine the nodal status prior to randomization:\r\n* Nodal status – negative\r\n** Imaging of the axilla is negative\r\n** Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative\r\n* Nodal status – positive\r\n** FNA or core biopsy of the node(s) is cytologically or histologically suspicious or positive\r\n** Imaging is suspicious or abnormal but FNA or core biopsy was not performed
Palpable lymph nodes present in the supraclavicular areas or higher in the neck, unless proven to be benign on fine needle aspiration or biopsy
Participants must have histological diagnosis consistent of Anaplastic Thyroid Cancer (ATC). Cytologic diagnosis by fine needle aspiration alone is not sufficient. Histologic diagnosis may be made by core needle biopsy, incisional biopsy, thyroidectomy, or other surgical biopsy. Fresh tumor biopsies (re-biopsy) should be obtained whenever feasible. The central pathology review may take place prior to or after the participant starts treatment with lenvatinib.
Patients must be willing and able to undergo a biopsy after signed consent and prior to registration; patients must have tumor tissue and blood samples available and be willing to submit tumor and blood samples; NOTE: core biopsy required; fine needle aspiration (FNA) is not an acceptable substitute for core biopsy
An archived tumor block or punches instead block must be available for submission for PD-L1 analysis. If an archived tumor block sample cannot be shipped for this study, then two 3mm punches from the core needle biopsy blocks may be provided for analysis. NOTE: core or excisional biopsy is required for this study. Fine needle aspirates (FNA) and cytology specimens are not adequate for PD-L1 analysis.
A formalin fixed paraffin embedded lymph node or tumor biopsy specimen must be submitted during the Screening Period. The specimen must have been acquired by a surgical or core needle biopsy (? 2 cores at baseline); material from a fine needle aspiration is not acceptable.
Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1.
Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
provide a newly obtained tumor tissue sample. Tumor tissue biopsies may be taken by surgical resection, core needle biopsy, or fine needle biopsy
At least 1 of the tumor sites must be amenable to core needle biopsy and this may not be the site of disease used to measure antitumor response
Histologic diagnosis of unresectable or metastatic melanoma; for unknown primary disease, diagnosis of metastatic disease by cytology fine-needle aspiration (FNA) is not acceptable; BRAF wild-type confirmed, and NRAS mutation assessed
Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to enrollment date; bone marrow aspiration and/or biopsy are allowed
Patients with skin metastases must agree to tumor fine-needle aspiration (FNA) required by protocol
Pathologically confirmed invasive breast cancer by core needle biopsy
Surgical axillary staging procedure prior to study entry \r\n* Note: fine-needle aspiration (FNA) or core needle biopsy of axillary node is permitted
Subject entering the study will need to consent for mandatory biopsy at study entrance and as an optional procedure at week 11 and at progression for biomarker evaluation; biopsy should be excisional, incisional or core needle; fine needle aspiration is insufficient
Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry.
Patients who had a stereotactic needle biopsy
Pathologically proven diagnosis of adenocarcinoma of the rectum (located below the peritoneal reflection or begins within 15 cm of the anal verge on flexible endoscopy) within 90 days of registration; diagnosis of rectal adenocarcinoma must be obtained by biopsy technique that does not completely excise the lesion (eg, fine needle aspiration, core needle biopsy)
Fine needle aspirations or core biopsies =< 7 days prior to registration/ randomization
Fine needle aspirate within 7 days prior to enrollment.
STEP 1 ENROLLMENT: the patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration; mixed tumors will be categorized by the predominant cell type
STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration; mixed tumors will be categorized by the predominant cell type
Patients with biopsy proven stage IIIC/IV epithelial ovarian cancer, primary peritoneal, fallopian tube carcinoma; if a core biopsy is not possible, fine-needle aspirate showing adenocarcinoma is acceptable in the setting of a pelvic mass and presence of metastasis outside the pelvis measuring at least 2 cm, regional lymph-node metastasis or proof of stage IV disease, and ratio of cancer antigen (CA) 125 to carcinoembryonic antigen (CEA) greater than 25; if CA 125 to CEA ratio is 25 or lower, barium enema, gastroscopy, and mammography must be negative
Definitive pathologic diagnosis by needle core biopsy
Has a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion. Participants who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample.
Patients with diagnosis by fine needle aspiration (FNA) cytology only
For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred).
Availability of archival diagnostic tissue (paraffin tissue block, cytospin block from a fine needle aspirate, or unstained slides from resected tumor, core biopsy, or fine needle aspirate) is required
Histologic documentation of invasive breast cancer by core needle or incisional biopsy; excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study
Endoscopic ultrasound (EUS) with fine needle aspirate (FNA) for cytology
Diagnosis of invasive adenocarcinoma of the breast made by core needle biopsy
Tumor tissue from fine needle aspiration is not acceptable.
Willing and able to undergo a post-dose core needle biopsy.
Histologic diagnosis of unresectable or metastatic melanoma; for unknown primary disease, diagnosis of metastatic disease by cytology fine needle aspiration (FNA) is not acceptable
Needle biopsy or incisional biopsy
Histologically confirmed classical or lymphocyte predominant Hodgkin's lymphoma that is relapsed or refractory after at least one prior chemotherapy\r\n* Core-needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping\r\n* Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be used in conjunction with nodal biopsies\r\n* Fine-needle aspirates are not acceptable\r\n* If the original diagnostic specimen is not available, specimens obtained at relapse may be utilized
Patients must have at least three core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained at baseline); at least 1 core with Gleason sum >= 8; a prostate biopsy within 3 months from screening is allowed for entry requirements
Exogenous sex steroid use within 4 weeks prior to core needle biopsy
Known regional malignant-appearing adenopathy or extra-biliary mass, indicating the need for concurrent endoscopic ultrasound with fine needle aspiration (EUS-FNA).
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy, or two positive sputa) of small cell lung cancer (SCLC)
Coaxial biopsy technique using Angiotech 19-gauge introducer needle
Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration
Willingness to undergo EUS with possible fine needle aspiration (FNA)
Participants must have a diagnosis of DCIS made by core needle biopsy
Women who were using oral contraceptives or postmenopausal hormones within eight weeks prior to core needle biopsy, and then stopped following core needle biopsy, are not eligible; use of hormone coated IUD like Mirena is allowed
Prior or current random periareolar fine needle aspiration (RPFNA) evidence of atypia
There has been a sufficient interval between a breast procedure and the RPFNA: at least 2 months for a prior RPFNA, at least 2 months for a core needle biopsy, at least 3 months for an excisional biopsy
Must be willing to undergo fine needle aspiration of breast adipose tissue at 0 and 3 months of the study
Barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (FNA) sampling as determined by clinical examination and/or mammogram
Surgical axillary staging procedure prior to first definitive breast operation; Note: fine-needle aspiration (FNA) or core needle biopsy of axillary node is permitted
Patients must have an imaging abnormality that necessitated a core needle biopsy
Patients must be registered on study within 100 days after core needle biopsy
Palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA
Patient registered on study more than 100 days since the date of core needle biopsy
Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-needle aspiration
Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration
Any prior needle biopsy of the prostate
Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy
Women with histologically confirmed breast cancer (by core needle biopsy)
Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks
Requiring tissue diagnosis (fine needle aspiration [FNA], core biopsy, surgical biopsy, surgical resection), or clinical follow-ups for at least 6 months
A core needle biopsy or fine-needle aspiration (FNA) is acceptable for diagnosis of metastatic disease in lymph nodes
Patients who are candidates for thyroidectomy based on fine needle aspiration biopsy results of dominant (> 1.5 cm) thyroid nodules will be considered for study enrollment.
Current hormone replacement therapy (HRT), selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) use; if yes, the wash-out period is 30 days before diagnostic core needle biopsy\r\n* Note: local therapy (i.e. estrogen cream) will be permitted due to low systemic absorption of estrogen\r\n* Note: if patient is registered prior to completed washout, diagnostic core needle biopsy date will need to be provided
The participant has a primary brain tumor
IDH mutation status of the primary tumor must be available or tumor samples must be available for pre randomization testing
Central nervous system (CNS) embryonal tumor other than medulloblastoma or PNET in the posterior fossa, for example, patients with diagnosis of atypical teratoid/rhabdoid tumor (ATRT), supratentorial PNET, pineoblastoma, ependymoblastoma, embryonal tumor with abundant neuropil and true Rosettes (ETANTR) are excluded
Newly diagnosed patients must have histologic verification of a primary extracranial germ cell tumor in any of the categories outlined; elevation of serum tumor markers without histologic confirmation is not sufficient for entry on the trial\r\n* NOTE: for low risk patients, materials for rapid surgical central review must be sent within 7 days of study enrollment
Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible
Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if excision was attempted or accomplished as long as adequate anatomic imaging (MRI for most primary tumor sites) was obtained prior to surgery
No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass
Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:\r\n* Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin\r\n* Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma\r\n* No prior tumor resection or biopsy
Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:\r\n* No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.]); horner syndrome is not considered neurologic compromise\r\n* No prior tumor resection, tumor biopsy ONLY\r\n* Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1
There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy
Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]
Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment; tumor may have originated in any primary site\r\n* NOTE: in rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established; this would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels [HCG >= 500; AFP >= 500] and typical pattern of metastases)
Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multi-disciplinary tumor board (must be documented in the CRF during screening)
CNS GCT including pure germinoma and MMGCT; patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study; patients with mature/immature teratoma who have tumor marker elevations are eligible on this study; patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations
Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study
Resection of at least 80% of the volume of the tumor is feasible; resectability will be determined by the surgeon and radiologist after discussion among the multidisciplinary team
The maximum radiation target volume for GTV3 is 65 cc (per NRG Oncology guide); patient may be excluded after the first sMRI scan if the GTV3 volume is greater than 65 cc (we anticipate that contrast-enhancing tumor volume [residual tumor volume following tumor resection] would be less than 20 cc)
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Tumor deposits that are clearly accessible for serial tumor biopsies - a patient’s biopsied lesion must be at least 1 cm in diameter (in at least one dimension)
Patients must have evidence of recurrent or metastatic carcinoma by one or more of the following:\r\n* The appearance of metastatic disease by standard imaging techniques\r\n* The appearance of rising serum tumor marker, AFP or beta-hCG\r\n* NOTE: If a rising tumor marker is the only evidence of progressive disease, at least 2 consecutive rising values at least one week apart are needed; patients with only evidence of disease is rising tumor marker AFP and beta-hCG will be provided alternate causes of increased serum levels of these markers are not present, such as cross reaction with luteinizing hormone (LH) (that can be tested if needed by testosterone suppression of LH), hepatitis, use of marijuana or second primary tumor, etc
Patients must have archival tumor tissue or agree to a tumor biopsy for mutation and biomarkers analysis unless previously discussed with sponsor's medical monitor or its designee (fresh tumor biopsies are recommended at baseline in patients with readily accessible tumor lesions and who consent to the biopsies). Patients with ovarian, fallopian tube, primary peritoneal, or breast cancer in Part A and all patients enrolled in Part B must also agree to provide fresh blood sample at the baseline for the evaluation of BRCA mutations and/or confirmation of prior BRCA results or other homologous reconstitution deficiency mutation even if it was previously tested.
Willing to consent to tumor biopsies during the study
All patients must have had an MRI of the brain and spine that has measurable tumor (not only diffuse leptomeningeal tumor) within two weeks prior to study enrollment; Note: central review of MRIs is required, but may be completed concurrently with patient registration; completion of central review is not required prior to starting treatment
Macrovascular tumor invasion.
Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
Tumor Treatment Field (TT Fields) therapy allowed.
Known to be T790M+ (on pre-treatment tumor or plasma) or known germline T790M
Participant must be willing to undergo tumor biopsies prior to treatment and on Cycle 2 Day 1. In the Phase 2 part of the trial, participants with bone-only disease, or participants for whom a biopsy is contra-indicated, may opt out of providing tumor biopsies. Note: A subset of participants in Phase 2 will be required to provide tumor tissue until tumor pairs have been collected from at least 15 ER?WT and 15 ER?mut (determined by sponsor-designated central laboratory test).
Any patient with suspected brain tumor on diagnostic MR imaging who will undergo a resection
Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (eg, carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
Tumor accessible for biopsies and agreement to conduct pre-dose and post-dose fresh tumor biopsies.
Known to be T790M+ (on pre-treatment tumor or plasma) or known germline T790M
Platelets ?70x103/?L (? 70 x 10^9/L) (superficial tumor dosing only)
Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.
largest tumor volume < 10 cc
The participant has a primary brain tumor
Can supply tumor tissue for study analyses (dependent on tumor type)
Tumor(s) involving the brain stem
INCLUSION - INFUSION: EBV positive tumor
Pathological diagnosis for the resected tumor demonstrates transformation to higher grade (i.e. WHO grade III or IV) gliomas; if a patient is diagnosed as high-grade glioma (HGG) upon resection after receiving the pre-surgical treatment, the patient will be withdrawn from the study and considered for therapeutic options for HGG (trials for HGG or standard of care); the tumor tissue of such a case would be brought to the lab before the pathological diagnosis is made? and thus would be processed before the lab is informed of the final HGG diagnosis; will evaluate the tumor tissue to help us develop future approaches for HGG
Tumor invades a major blood vessel
A hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the non-tumorous liver parenchyma on arterial phase computed tomography scans)
Patients with T1 primary tumor or T4 large volume tumor that has resulted in larynx dysfunction at baseline (for example tumor largely penetrating into base of tongue and resulting in inability to swallow at baseline)
RAS wild-type; both KRAS and NRAS testing are necessary; the presence of pathogenic mutations in KRAS or NRAS is exclusionary; primary tumor or metastatic tumor may be tested
Patients must have evaluable tissue/blood for testing as specified by the concurrent FoundationOne criteria; this will be obtained during the standard of care tumor diagnosis and tumor staging evaluation
PHASE I: In order to perform a retrospective biomarker analysis with the next generation gene sequencing UW-OncoPlex assay; fresh tumor biopsies from metastatic or primary tumor lesion will be done if considered safe and feasible by treating physician and radiologist; Patients who already have OncoPlex or other equivalent gene sequencing assay (eg Foundation One, Perthera, Caris etc) test results available from prior tumor biopsy are eligible to participate, without the needed of a repeat tumor biopsy, but the test results need to be provided to the study principal investigator
PHASE IB: Fresh tumor biopsies from metastatic or primary tumor lesions will be done only if considered safe and feasible by treating physician and radiologist; patients who already have OncoPlex or other equivalent gene sequencing assay (eg Foundation One, Perthera, Caris etc) test results available from prior tumor biopsy are eligible to participate, without the needed of a repeat tumor biopsy, but the test results need to be available to the study principal investigator
Tumor suspected or known to invade the esophagus
Patients with bulky tumor on imaging are ineligible; treating physicians are encouraged to contact the study chair to request a rapid central imaging review to confirm fulfilment of these eligibility criteria, if they have concerns\r\nBulk tumor is defined as:\r\n* Tumor with evidence of clinically significant uncal herniation or midline shift\r\n* Tumor with diameter of > 5 cm in one dimension on T2/fluid attenuated inversion recovery (FLAIR)\r\n* Tumor that in the opinion of the site investigator, shows significant mass effect in either the brain or spine\r\n* Multi-focal/ metastatic disease: \r\nNote: A second focus of enhancement in a single FLAIR abnormality is permissible and will not exclude the subject\r\n** Patients with multi-focal parenchymal disease are ineligible\r\n** Patients with leptomeningeal metastatic disease are eligible\r\n* Strata B, D and E – patients whose tumor has a significant component involving the brainstem or with significant fourth ventricular compression are ineligible
INCLUSION CRITERIA FOR STRATUM C: Patients must have a histologically confirmed primary brain tumor that is recurrent, progressive or refractory; inclusion criteria encompasses all types of brain tumors (e.g. gliomas, embryonal tumors or any other type of brain tumor as long as other eligibility criteria are met;\r\n* Patients with high-grade gliomas are eligible for this clinical trial at least 2 weeks after completion of radiotherapy independent of tumor progression/recurrence as long as they are not enrolled on any other therapeutic clinical trial and there is macroscopic residual disease\r\n* Patients with other concomitant tumors associated with CMMRD syndrome including gastrointestinal polyps/adenomas and carcinomas, lymphomas and leukemias will be eligible as long as they are not requiring anticancer therapy directed against these other cancers and meet all other eligibility criteria
Phase II: if surgical resection/debulking prior to MLA is not indicated, a biopsy of the tumor will be done at the same time of MLA to obtain tumor tissue for both diagnostic purposes and immune monitoring
Patients must be untreated with curative-intent surgery for current diagnosis of stage III, IVa, or IVb disease; diagnostic biopsy of primary tumor and/or nodal sites is permitted.  \r\n* Diagnostic simple tonsillectomy is permitted, provided patient has Response Evaluation Criteria in Solid Tumors (RECIST)-measurable residual tumor and/or nodal disease\r\n* Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy/radiotherapy), and has not recurred
Cryoablation can be performed near vessels of the head and neck, and if deemed necessary tumor may be displaced using a saline injection (hydrodisplacement); tumor displacement from nerves may be required and will be performed as deemed appropriate to avoid nerve injury
Tumor size not measurable
EBV (+) nasopharyngeal carcinoma in the protocol treated tumor
Infra-tentorial tumor
Patient must have an original diagnosis, benefited by autologous transplantation, confirmed by biopsy* of solid tumor, including but not limited to: high-grade glial tumor, low-grade glial tumor, ependymoma, medulloblastoma, primitive neuro-ectodermal tumor (PNET), Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, retinoblastoma, or miscellaneous poor-prognosis solid tumors; lymphomas and other lymphoid malignancies will not be studied in this protocol\r\n* Brain stem glioma patients who have progressed after radiation therapy do not require histologic confirmation; brain stem gliomas are defined as intrinsic tumors of the pons causing diffuse enlargement; these patients are diagnosed on clinical and radiographic appearance of the lesion and the biopsy requirement will be waived for this group
COHORT B, GROUP 4: HEAD AND NECK SQUAMOUS CELL CARCINOMA: Patients must not have evidence of major vessel involvement or encasement by tumor; a tumor abutting a major blood vessel may be allowed after review of scans with the radiologist and discussions with the principal investigator (PI)
Criteria only for the randomized phase 2 part: mesothelin screen positive determined from archival tumor tissue and to be performed centrally. MSLN-positive is defined as >= 30% of tumor cells with membrane staining intensities >= 2+\r\n* For the run-in-phase 1, patients will not be selected based on the mesothelin expression
HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing
HER2-positive tumor (primary tumor or metastasis) as assessed by local (non-central) laboratory testing
Patient should have at least one remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm.
Any known tumor outside of the brain
Any known tumor outside of the brain
PHASE I: Patients with recurrent, refractory, or progressive non-hematologic malignancies (central nervous system [CNS] or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible; LGG is defined as any World Health Organization (WHO) grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor
Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F
Infra-tentorial tumor
No individual tumor size is >50 mm3
Patient has symptoms related to hormone production from tumor (i.e. functional tumor)
Biopsy-proven benign or malignant brain tumor requiring tumor bed or tumor irradiation; this may include, but is not limited to, low-grade or favorable high-grade glioma, pituitary adenoma, vestibular schwannoma (acoustic neuroma), and meningioma as the most common diagnoses; other tumor types that require irradiation and are deemed appropriate for proton radiation therapy are also eligible; patients with a presumed diagnosis based on imaging and clinical characteristics will be permitted on this trial without pathological diagnostic confirmation if it is within standard of care to offer radiation therapy without a biopsy
Patients must agree to consent for their tumor samples to be used for generation of cellular research tools such as organoids
Histologically proven malignancy necessitating cranio-spinal irradiation; this will include patients with a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (SPNET), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), atypical teratoid/rhabdoid tumor (ATRT), and disseminated low-grade glioma (LGG) or histologically confirmed germ cell tumor or elevated alpha-fetoprotein (AFP) (serum > 10 IU/L or cerebrospinal fluid [CSF] > than institutional norm) or B-HCG (serum or CSF > than institutional norm) in the setting of radiographic disease consistent with a germ cell tumor necessitating cranio-spinal irradiation
Patients must have a tumor or plaque that is refractory to conventional treatment including but not limited to one of the following (up to 4 lesions in a single field of PDT or RT will be considered for treatment):\r\n* Plaque stage disease that has failed at least 2 skin directed therapies (including topical steroids) or refractory plaques despite at least one systemic therapy or plaques with evidence of folliculotropism\r\n* The presence of a tumor of MF
It must be the surgeon’s expectation that >= 90 of the tumor can be treated with LITT to the yellow TdT line (i.e. 43 degrees for 2 min)
Tumor must be unifocal & unilateral
HER2-positive tumor status;
Tumor visible on multiparametric MRI
Subjects without baseline tumor imaging
Evidence of active tumor lysis syndrome based on laboratory assessment
Tumor deemed accessible by metastatectomy (TIL harvest) which expects to yield > 1.5 cm^3 of resectable tumor amount
The subject must have EGFR and c-Met overexpressed in tumor as determined by immunohistochemistry (IHC) test score of 2+ for both markers
Patients with tumor(s) invading a major vascular structure (e.g. carotid artery) or other key anatomical structure (e.g. pulmonary airway) in the event of post treatment tumor swelling and/or necrosis (hepatic and portal vein involvement allowed)
Intrahepatic lesion amenable to pre and post SBRT biopsies, unless the investigator determines that the tumor biopsies would be unsafe
Total tumor burden requiring ? 75 mL AvidinOX injection
Primary tumor not amenable to TORS
Must have marker clip indicating location of target tumor in breast
Either the primary tumor and/or the metastatic tumor must be RB positive as defined below:\r\n* RB status: the invasive tumor must have greater than 50% of tumor cells staining positive for RB
Evidence of tumor expression of CA19-9 based on IHC performed on tumor samples or elevated serum levels (?1.5 x ULN) of CA19-9 considered secondary to tumor
Patients will be eligible if tumor is metastatic, unresectable, progressive, or if complete tumor resection is not considered to be feasible without substantial risk or morbidity
This study will include all patients clinically suspected or histologically confirmed solid or hematological malignancy who have undergone or will undergo genetic testing of their tumor; patients may have failed first-line or standard therapy for their disease (refractory) or have no options for curative therapies; rare cancers that are metastatic at diagnosis are by definition refractory and may be included in the first line setting, at the discretion of the principal investigators; rare cancers may not have standard of care therapies - a disease/tumor is considered rare if the incidence is < 6/100,000/year using the National Cancer Institute (NCI) RareCare tumor list, or if the disease is a molecular or biologically defined subset such that the annual incidence is < 20,000 in the United States
Patients with tumor morphology that predicts poor coverage of the majority of the tumor; this will be determined by the study chairs; patients with evidence of cystic changes greater than 1 cm in diameter will be excluded; these subjects should be discussed with the study chairs
Must have a diagnosis of a solid tumor (except primary brain tumors), acute myeloid leukemia (AML), or non-Hodgkin lymphoma (NHL); NHL may be of any subtype for Dose Escalation but is limited to diffuse large B-cell lymphoma (DLBCL) for those enrolled to the cohort evaluating the combination of ABBV-621 and venetoclax. Subjects in the Dose Optimization solid tumor cohorts must have either colorectal cancer with documented KRAS mutations (as determined by local testing), or pancreatic cancer (irrespective of mutational status).
Has a diagnosis of low grade (G1 or G2), uni- or multifocal papillary appearing bladder tumor, stage Ta.
Has or has ever had: upper tract TCC; urethral tumor (prostatic urethra included); any invasive bladder tumor known to be other than tumor Ta, low-grade (G1-G2); any evidence of lymph node or distant metastasis; any bladder tumor with histology other than TCC; or carcinoma in situ (CIS).
For subjects with recurrent tumor, the subject had at least a 6-month cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
Original diagnosis has been confirmed through a histopathologic review of the primary tumor slides by an expert pathologist at the Principal Investigator's institution
Subjects that do not have a baseline tumor specimen/biopsy prior to starting study medications\r\n* Tumor specimens do not need to be at Jefferson at time of eligibility determination; tumor specimens held at outside institutions should be requested for analysis of pre-treatment tumor vs post-treatment tumor
The tumor must be accessible for injection
Tumor which invades the ventricular system or located in the brain stem
No individual tumor size is >50 mm3
FULL STUDY INCLUSION CRITERIA: Histological documentation of overexpressing mesothelin at the moderate (2+) or stronger (3+) level in at least 30% of tumor cells as determined by immunohistochemistry (IHC)
FULL STUDY INCLUSION CRITERIA: Extent of baseline tumor burden will not interfere with causal assessment of treatment-emergent hepatotoxicity, at the investigator’s discretion
Tumor accessible and participant consents to undergo fresh tumor biopsies.
Patients must agree to enroll on the Neuro-Oncology Branch (NOB) Natural History protocol to allow the assessment of molecular tumor markers
Tumor size at least 5 mm with planned primary surgery at Mount Sinai
ACTolog target expression as evaluated by the in vitro diagnostic device IMA_Detect: Patient's tumor must express at least one ACTolog target as assessed by quantitative PCR (qPCR) (to be assessed from a tumor biopsy to be performed if all other eligibility criteria are met).
Subjects that do not have a baseline tumor specimen/biopsy prior to starting study medications\r\n* Tumor specimens do not need to be at Jefferson at time of eligibility determination; tumor specimens held at outside institutions are not a reason for exclusion; samples from outside institutions should be requested for analysis of pre-treatment tumor versus (vs) post-treatment tumor
Inaccessible tumor or lack of consent for sequential biopsies
Primary tumor >= 3 cm (for all stages entered) to increase the likelihood that excess tumor will be available after resection
Histologically confirmed solid tumor malignancy for which no curative therapy exists with at least 25% of tumor cells expressing mesothelin as determined by NCI Laboratory of Pathology; determination can be made using archival tumor tissue or fresh biopsy; subjects with epithelioid mesothelioma and pancreatic adenocarcinoma are automatically eligible and are not required to have this test
Low tumor burden according to GELF criteria defined as:
Maximal contiguous volume of tumor based on high b-value diffusion MRI < 1/3 volume of brain
Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively by the surgeon and when necessary (determined by the surgeon) tumor board review
Patients deemed to have un-resectable disease by the treating surgeon or upon tumor board review
Radio-opaque markers must be present within the tumor bed; in patients who have undergone surgical resection, radio-opaque surgical clips within the tumor bed can be used as fiducials; patients without surgical clips in the tumor bed must be able to have fiducials placed endoscopically, laparoscopically, or through a computed tomography (CT)- or ultrasound-guided technique; if not, the tumor must be posterior and adjacent to the aorta, and treatment will only be permitted at the discretion of the principal investigator
Patients with evidence of gross tumor invasion into the lumen of the stomach or small bowel are not eligible; if imaging suggests luminal invasion of tumor, this must be ruled out endoscopically before the patient can be enrolled on study
Patients must be untreated with curative-intent surgery for current diagnosis of stage III, IVa, or IVb disease; diagnostic biopsy of primary tumor and/or nodal sites is permitted\r\n* Diagnostic simple tonsillectomy is permitted, provided patient has Response Evaluation Criteria in Solid Tumors (RECIST)-measurable nodal disease\r\n* Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy or radiotherapy), and has not recurred
A minimum tissue requirement of >= 3 core biopsies with tumor involvement and at least 50% tumor involvement in one of the core biopsies is required
The primary tumor in the colon or rectum may be intact or resected
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): ROR1 expression in > 20% of the primary tumor or metastasis by immunohistochemistry (IHC)
INCLUSION CRITERIA FOR TNBC: ROR1 expression in > 20% of the primary tumor or metastasis by IHC
Tumor located entirely in the infratentorium.
Evidence of > 1 area of CIS not associated with papillary tumor at this time
Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor
There is no specific tumor size cut-off for this protocol; however, the radiation treatment plan must meet the protocol’s dose constraints
If a primary tumor is in place, it must be asymptomatic
Evidence of MCPyV TAg tumor expression by immunohistochemistry on any prior or current tumor specimen or viral oncoprotein antibody confirmation within 6 weeks of the start of study intervention
Need for urgent or emergent nephrectomy to relieve symptoms relating to the primary tumor
Unequivocal metastatic tumor at baseline
Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)
cPoP study: any tumor with at least 2 (sub)cutaneous tumor/metastases at least 2 cm apart which are RT naïve with an indication for high dose palliative RT
Willing to have tumor biopsies collected in cPoP
Patients must have an extra-cranial primary tumor diagnosis
Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
Primary brain tumor
Tumor for which adequate radiation dosage cannot be safely delivered
The subject has a primary brain tumor
Circumferential radial margin not involved with tumor on pelvic MRI
cTis-T3 cancer judged to benefit (by treating radiation oncologist) from a tumor bed boost
Tumor thrombus must be >= level II
Patient’s tumor must be deemed resectable by the study team prior to registration; borderline resectable patients will be excluded
Patients must have documented available tumor greater than 1 cm of bulk tumor mass or 200 cc of ascites fluid for tumor isolation prior to starting chemotherapy
Able, willing to give written consent for available archival tumor samples (not mandatory) and tumor biopsies before and during protocol therapy (mandatory).
An HRD score >= 42 on the Myriad HRD Assay as assessed on a metastatic tumor biopsy sample; in the case that an adequate metastatic tumor tissue biopsy is not feasible, we will assess the HRD score from the primary breast tumor
Patients already enrolled to the separate Tumor Genomic Analysis and Molecular Testing for Personalized Cancer Therapy study, for which a personalized therapeutic plan has been successfully created under that protocol and selected by the multidisciplinary tumor board of experts (MTBE) for use in this therapeutic clinical trial
Clinical T4 tumor
Tumor < 3 mm from the mesorectal fascia as seen on MRI or endorectal ultrasound
Patients with contrast-enhancing tumor component crossing the midline, actively growing multi-focal tumor, infratentorial tumor or tumor dissemination (subependymal or leptomeningeal)
Bilirubin < 2.0 mg/dL unless secondary to bile duct blockage by tumor
Patients with gastrointestinal stromal tumor (GIST)
Patients must have a measurable primary tumor (undetectable NSCLC primary tumor is ineligible)
Presence of nodules considered neoplastic in the same lobe or other ipsilateral lobe as the primary tumor (stage T3-4), unless the nodule can be encompassed in the stereotactic boost (gross tumor volume [GTV]boost) without exceeding a total GTVboost size of 10 cm as defined by the sum of the largest CT axial dimensions of each nodule
Confirmation that primary tumor expresses mammaglobin-A by IHC
IDH1^R132H expression in primary tumor
Participant must be in need of a craniotomy for tumor resection or a stereotactic brain biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy
T4 tumor
Less than 6 months from the date that local treatment (surgical or radiation) of the primary tumor was finalized
Patients must have an extra-cranial primary tumor diagnosis
Primary brain tumor
Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
The subject has a primary brain tumor
Nonparenchymal tumor dissemination (e.g., subependymal or leptomeningeal)
Infratentorial, leptomeningeal, or multifocal tumor
A volume of enhancing tumor which falls within the treatment field volume being evaluated in the respective cohort
Tumor located in the brainstem
Multifocal primary tumor
The primary tumor involves true vocal cord(s) (glottis) or arytenoid(s)
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
EBV positive tumor (can be pending)
EBV positive tumor
The targeted tumor tissue is located in the cerebral hemispheres, > 2.5 cm from the inner table of the skull. Non-targeted parts of the tumor may extend outside the treated tumor limits.
The tumor's not visible on the pre-therapy imaging
The tumor presenting the following imaging characteristics
The sonication pathway to the tumor involves
Patients must have either (1) a diagnosis of NB as defined by international criteria i.e., histopathology (confirmed by the Memorial Sloan-Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow (BM) metastases plus high urine catecholamine levels, or (2) a tumor that is GD2-positive by immunostaining with m3F8\r\n* A non-NB tumor is defined as GD2-positive by immunostaining with m3F8; if fresh or frozen tumor is not available for immunostaining, patients will be considered eligible if published reports show that > 50% of that tumor type is GD2-positive by immunohistochemistry; (Note: tissues must be fresh/frozen as fixed, paraffin-embedded specimens are unsuitable for anti-GD2 immunostaining); tumors known to be GD2-positive by this criteria do not need immunostaining; these include: melanoma (> 50%), desmoplastic small round cell tumors (70%), osteosarcoma (88%) and soft tissue sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, and spindle cell sarcoma (93%)
Uncontrolled tumor in the brain
Participants for whom chemotherapy or intraoperative or post-operative radiation therapy is planned as part of the overall primary tumor treatment
Patients with primary tumor histology of lymphoma, leukemia, or germ cell tumor
ICGCT including pure germinoma and MMGCT; patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study; patients with mature/immature teratoma who have tumor marker elevations are eligible on this study; patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations
Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study
Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein.
WHO grade II: any tumor, either completely or incompletely excised; any recurrent tumor
WHO grade III and hemangiopericytoma: any tumor, either completely or incompletely excised; any recurrent tumor
The tumor volume must be a minimum of three times the injection volume; in the first and second dose levels, the lesion to be injected must be at least 18 mm in each of 3 dimensions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) scans; lesions not meeting this requirement may be used if volumetric measurements show it to be >= 3 mL; in the third dose level, the lesion(s) to be injected must meet minimal tumor measurements and volume for each 1 mL fractionation of the injection volume (5mL); a single lesion meeting this requirement may be injected or the total volume may be distributed in up to 3 lesions meeting measurement and volume requirements as follows:\r\n* 5 mL of HSV1716; 30 mm minimum tumor length in each dimension; 15 mL minimum tumor volume\r\n* 4 mL of HSV1716; 28 mm minimum tumor length in each dimension; 12 mL minimum tumor volume\r\n* 3 mL of HSV1716; 26 mm minimum tumor length in each dimension; 9 mL minimum tumor volume\r\n* 2 mL of HSV1716; 23 mm minimum tumor length in each dimension; 6 mL minimum tumor volume\r\n* 1 mL of HSV1716; 18 mm minimum tumor length in each dimension; 3 mL minimum tumor volume\r\n** Thus, the full 5 mL may be injected into a >= 15 mL tumor; 2 mL each may be injected into two >= 6 mL tumors plus 1 mL into a >= 3 mL, tumor, etc.; if a patient has multiple lesions but these criteria for injection cannot be met, they may be considered for the intravenous arm
Patients with skin involvement, regardless of tumor size
Patients must have a histologically confirmed diagnosis of a malignancy known to be 8H9 reactive; 8H9 expression must be confirmed by immunohistochemical staining of tumor and assessed by the Department of Pathology or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma or an embryonal tumor (such as medulloblastoma, retinoblastoma, rhabdomyosarcoma and desmoplastic small round cell tumor [DSRCT])
Must be willing to release tumor biopsy specimen used for diagnosis of metastatic NSCLC (if available) for additional exploratory tumor molecular profiling.
Subject's tumor expresses CLDN18.2 in ? 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
Metastatic tumor that has been biopsied
Centrally assessed KIR3DL2 expression on tumor cells.
Tumor foci detected below the tentorium or beyond the cranial vault.
The targeted tumor tissue is located in the cerebral hemispheres, > 2.5 cm from the inner table of the skull. Non-targeted parts of the tumor may extend outside the treated tumor limits.
Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
The maximum tumor diameters for each Cohort for both Arm A and Arm B should achieve a dose of approximately 1x1011 viral particles (vp)/cm3 of tumor volume. (see Table 1). Please refer to Table for calculating tumor volume.
Staining for PD-L1 in less than half of the tumor cells using the 22C3 antibody (0% staining is acceptable).
Maximal contiguous volume of tumor based on high b-value diffusion MRI and perfusion MRI < 1/3 volume of brain.
Histological or cytologically confirmed NSCLC that shows moderate or stronger mesothelin expression in 30% of tumor cells by a companion assay; MSLN expression score using Ventana immunohistochemistry (IHC) SP74 assay; Phase I only: In addition 5- 30% tumor cells and 1, 2, or 3+ MSLN score; Phase II only: 30% tumor cells and either 2+/3+
Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck, with an indication for surgical therapy\r\n* T1N1-N2B, T2-4N0-N2b stage are generally eligible\r\n* If determined per tumor board that a low-volume/non-bulky tumor of another stage is appropriate for resection (e.g. small volume T4 with a small amount of bone invasion) such tumors may also be considered for this study if recommendation in tumor board is such
Tumor expressing PRAME and/or COL6A3.
Her-2 positive gastric tumor
Histopathologic documentation any metastatic gastrointestinal tumor
T4 tumor
Surgery is done prior to IMT if needed for palliation, tumor debulking, pathological documentation of tumor recurrence; the patients may continue on study therapy even if they do not have measurable disease
Patients with bulky tumor on imaging are ineligible; bulky tumor is defined as:\r\n* Tumor with any evidence of uncal herniation or midline shift\r\n* Tumor that in the opinion of the site investigator, shows significant mass effect\r\n** Treating physicians are encouraged to contact the study chair to request a rapid central imaging review to confirm fulfilment of these eligibility criteria, if they have concerns
Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ? 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
All patients treated at doses > 120 mg per day must have medullary thyroid cancer (MTC), or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.
Diagnosis during dose expansion (Part 2) - All patients in Groups 1, 2 and 4 must have a RET-altered (excluding synonymous and nonsense mutations) solid tumor, as determined by local testing of tumor or circulating tumor nucleic acid in blood; as detailed below.
Tumor location in the brain stem
Diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact; Note: prior to randomization, the investigator must specify and document each of the following: \r\n* Distance of the lowest tumor margin from the anal verge; and \r\n* Intent for sphincter sparing or non-sphincter sparing surgical resection according to the primary surgeon; and\r\n* The majority of the untreated tumor must be < 12 cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon
Subjects with histologically confirmed CNS embryonal tumor (primitive neuroectodermal tumor [PNET], medulloblastoma, atypical teratoid rhabdoid tumor [ATRT], medulloepithelioma, pineoblastoma or ependymoblastoma), or germ cell tumor, are eligible; tumors must be relapsed or refractory to first-line therapy; diagnosis will be made on the basis of computed tomography (CT)-assisted or stereotactic biopsy, open biopsy, surgical resection, cerebrospinal fluid (CSF) cytology, or elevated tumor markers
The subject has an infra-tentorial tumor or multifocal disease
Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink)
Diagnosis of MPM, confined to single pleural cavity, with histologic confirmation of the primary tumor
Any tumor-specific or clinical features that make surgical intervention unsafe in the opinion of the treating neurosurgeon
Willing to consent to allow access to known archival tumor tissue (NOTE: designated pathologist from participating site OR lead principal investigator must sign-off to ensure “sufficient” tumor should be available for support of tumor imaging studies [multi-color immunofluorescence])
Extremely radiosensitive tumor (lymphoma, leukemia)
Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor
Patients with acute leukemia will be excluded because they will likely have a much greater circulating tumor burden, which would increase the risk of infusion of clonal tumor cells
The tumor location must be suitable for either lobar or sublobar resection (wedge or segment)
Brain tumor patient is planning to undergo tumor resection or biopsy for the purpose of differentiating between tumor progression versus treatment-induced effects following radiation therapy and/or chemotherapy\r\n* If a patient has magnetic resonance imaging (MRI) findings consistent with tumor but does not already have a histopathologic diagnosis of cancer, s/he may sign the consent form, but final eligibility for study enrollment will be determined based on results of the frozen section at time of surgery
Extracapsular tumor extension
Subjects must have positive mesothelin expression in the archival tumor tissue, defined as the mesothelin membrane intensity score of 2+ or 3+ (on the 0-3 scale) expressed on the membrane of >= 10% of tumor cells
Patients must be untreated with curative-intent surgery for current diagnosis of stage III, IVa, or IVb disease; diagnostic biopsy of primary tumor and/or nodal sites is permitted\r\n* Diagnostic simple tonsillectomy is permitted, provided patient has Response Evaluation Criteria in Solid Tumors (RECIST)-measurable nodal disease\r\n* Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy or radiotherapy), and has not recurred
Patients must have recurrent or persistent ovarian, fallopian tube, peritoneum, and endometrial clear cell carcinoma; primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology; in addition, the tumors should be negative for expression of Wilms tumor 1 (WT-1) antigen (with the exception of endometrial cancers where WT-1 stains are not required) and estrogen receptor (ER) antigen by immunohistochemistry; focal, weak, ER staining of tumor cells (< 5%) is permitted; appropriate tissue sections must be available for histologic evaluation for central pathology review by Gynecologic Oncology Group (GOG); immunohistochemical stained slides for ER and WT-1 antigen must be available for review by GOG\r\n* If the primary tumor had at least 50% clear cell histomorphology, a biopsy of the recurrent or persistent tumor is not required; however, immunohistochemical studies of the primary tumor for ER and WT-1 antigens should be performed and the slides submitted to the GOG for review; the percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report; if slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), biopsy of recurrent or persistent disease is required\r\n* If the primary tumor had less than 50% clear cell histomorphology (or if slides of the primary tumor are not available for review), a biopsy of the recurrent or persistent tumor is required to confirm at least 50% clear cell histomorphology and lack of immuno-reactivity for ER and WT-1 antigens by immunohistochemistry; the percentage of involvement must be documented in the pathology report or in an addendum to the original report
The patient must be in need of a craniotomy for tumor resection or a stereotactic brain biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy
Patients must have a paraffin embedded tumor specimen from the kidney or metastatic site available for central review of tumor histology; tumor samples will be shipped as specified
Patients are preferred to have either a tumor mass amenable to core needle biopsy during the dosimetry phase, or a measurable tumor mass with at least one site of involvement measuring 2.0 cm in largest dimension on computed tomography (CT) imaging for purposes of planar and/or single-photon emission CT (SPECT)/CT tumor dosimetry (patients with disease that does not allow tumor dosimetry will be allowed on study since they still can contribute toward achieving the primary endpoint, but these patients will be given a lower priority over those with evaluable disease)
Rhabdoid tumor:
NI1-negative tumor:
DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue. Positive is defined as staining in ? 1% of tumor cells.
Subjects (NSCLC and gastric adenocarcinoma) must be determined to have HA-high levels from their tumor biopsies.
Uncontrolled tumor in the brain
Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen
Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen.
Patient must have archived primary tumor biopsies or surgical specimens, or biopsies of recurrent or metastatic samples
Non-GI solid tumors (like non-small cell lung cancer or breast cancer) should have confirmed CEA expression in tumor tissue >/= 20% of tumor cells staining with at least moderate to high intensity of CEA expression are required (immunohistochemistry [IHC]2+ and IHC 3+). For CRC, pancreatic and gastric cancer participants, the CEA assessment will be performed retrospectively and the result is not needed to enroll the participant. For the biomarker cohort, only participants with moderate/low CEA expression (< 20% of tumor cells with IHC2+/3+ and/or >/= 20% of tumor cells with IHC1+) and very low CEA expression (< 20% of tumor cells with IHC1+) will be enrolled. CEA expression should be determined prior to enrollment, if no archival tumor tissue is available, a fresh biopsy will be collected.
Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or tumor protein (p) 16 (in situ hybridization [ISH], immunohistochemistry [IHC] or genotyping testing); if you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing
If primary tumor has not been resected, it must be clinically stable
Five grams of resected tumor available for vaccine manufacture as determined by institutional pathologist; seven grams of tumor is preferred
All subjects must consent to provide archived tumor specimen
Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable; no tumor size criteria are used.
HER-2 negative tumor (primary tumor or metastatic lesion)
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
Index tumor involves the skull
Histologic diagnosis of a benign or borderline tumor (‘tumor of low malignant potential’) or of a malignant tumor of non-epithelial origin (such as a germ cell tumor, sex-cord stromal tumor) of the ovary, fallopian tube or peritoneum
Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.
Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
Operable tumor measuring >= 1.5 cm in maximal diameter\r\n* Any nodal status\r\n* Multifocal and multicentric disease is permitted\r\n* Synchronous bilateral invasive breast cancer is permitted\r\n* The tumor should be more than 5 mm from the skin
Tumor amenable to cryoablation as determined by radiologist
Tumor
Evidence of remaining tumor
PD-L1 strong expressing tumor as determined by immunohistochemistry (IHC) at a central laboratory
Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive
Skin involvement, regardless of tumor size
Phase 2: Prior talimogene laherparepvec, other oncolytic virus therapies, or tumor vaccines
The subject has a primary brain tumor
Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not more than 10 mm in maximal linear dimension; each tumor should comply with the maximal 7 Gleason score requirement.
Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial images.
Subjects with distance of the less than 2mm margin between the tumor and the prostate capsule
Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a high grade stage Ta or T1 tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion
Evidence of tumor-related hydronephrosis
Presence of punctate hemorrhage in the tumor.
Cancer Tumor Size: T4
Patient must have had their primary tumor treated with surgery and/or radiation
Histologic confirmation of malignancy (primary or metastatic tumor)
Urethral tumor (prostatic urethra included).
Any invasive bladder tumor known to be other than tumor Ta, G1-G2.
For patients with recurrent tumor, the patient had at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
Intact primary tumor (for Immune Response Cohort only)
Primary tumor resected
At least one measurable tumor accessible for intratumoral injection and EP on investigator’s assessment
Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
Documented survivin-positive tumor status
Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ treatment
Consent for tumor biopsies and blood draws for research purposes
Histologic documentation of the original primary tumor.
Primary brain tumor
If the primary tumor had at least 50% clear cell histomorphology, a biopsy of the recurrent or persistent tumor is not required; the percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report; if slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), biopsy of recurrent or persistent disease is required
RAS wild-type tumor; Note: evidence of EGFR expression in the tumor is not required
Low risk for tumor lysis syndrome (TLS)
Tumor enhancement involving both hemispheres
Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor; residual tumor is required for enrollment on study
Agreement to provide 2 tumor biopsies
Tumor location or involvement that would result in risk of ventricular penetration during tumor injection
Tumor involving brain stem
Participants who have had an incisional biopsy of the primary tumor or the primary tumor excised
AT THE TIME OF INFUSION: EBV positive tumor
PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
Participants enrolled to the RP2D cohort must have disease that is accessible for tumor biopsies and must agree to pre and on-treatment tumor biopsies
The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
Must have an FFPE tumor block with tumor cellularity of 20% or greater. NOTE: Prior to randomization, the tumor cellularity will be confirmed by central pathology review and percent values will be double checked at Paradigm (a Next Generation Sequencing Company).
Consent to preservation of frozen and fixed samples of tumor cores for evaluation
Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
KIT-mutant tumor, including melanoma or gastrointestinal stromal tumor (GIST), for which there is no standard systemic therapy, or
Patients must have a K-RAS wild-type (WT) tumor
Cystic component >= 25% the total volume of the tumor
Subjects must have a target VS with the following qualities:\r\n* Not amenable to surgery due to patient refusal, high risk for surgical complications (e.g., damage to lower cranial nerve function, tumor size > 3 cm in longest diameter, or multilobulated tumor appearance on MRI scan)\r\n* Associated with a word recognition score of < 85% and > 5%\r\n* Documented clinical progression defined as EITHER:\r\n** Progressive hearing loss (defined as a decline in word recognition score below the 95% critical difference interval from baseline score related to VS (i.e., not due to prior interventions such as surgery or radiation) OR\r\n** Progressive tumor growth in the preceding 18 months, defined as >= 20% increase in volume
Tumor of the patient is p53wt
Patient must not have transoral robotic surgery (TORS) for a T3 or T4 primary tumor
Patients must have either (1) a diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow (BM) metastases plus high urine catecholamine levels, or (2) a tumor that is GD2-positive\r\n* A non-NB tumor is defined as GD2-positive by immunostaining with monoclonal antibody 3F8 (m3F8); if fresh or frozen tumor is not available for immunostaining, patients will be considered eligible if published reports show that > 50% of that tumor type is GD2-positive by immunohistochemistry; (note: tissues must be fresh/frozen as fixed, paraffin-embedded specimens are unsuitable for anti-GD2 immunostaining); tumors known to be GD2-positive by this criteria do not need immunostaining; these include: melanoma (> 50%), desmoplastic small round cell tumors (70%), osteosarcoma (88%) and soft tissue sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, and spindle cell sarcoma (93%)
Tumor assayed for k-ras and other tumor genomic mutations
Tumor/vertebral body anatomy precluding fiducial placement
The participant has a primary brain tumor
Histologic confirmation of prostatic adenocarcinoma by Memorial Sloan Kettering Cancer Center (MSKCC) inclusive of the following:\r\n* 3 or more positive biopsy cores or equivalent tumor specimen as confirmed by pathologist\r\n* At least 2 cores containing >= 3 mm of tissue with carcinoma or equivalent tumor specimen as confirmed by pathologist\r\n* A primary tumor Gleason score >= 7\r\n* Adequate primary biopsy tissue or equivalent tumor specimen as confirmed by pathologist available for protocol required analysis (i.e., bladder or transurethral resection of the prostate [TURP] specimen)
Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop definition of tumor lysis syndrome; subjects may be enrolled upon correction of electrolyte abnormalities
HER2-positive as assessed by local laboratory on primary or metastatic tumor
Tumor is well visualized through x-ray mammography or ultrasound imaging and amenable to image guidance therapy (a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins
Tumor must be well visualized (as defined above) on MRI
Diagnosis of DIPG by MRI imaging defined as tumor that has a pontine epicenter and is diffuse (tumor that involves the majority [> 50%] of the brainstem) on T2 or fluid-attenuated inversion-recovery (FLAIR) imaging rather than focal; histologic confirmation is not required
Tumor must not invade the corpus callosum
Tumor must not invade the brainstem
Evidence of brainstem/cord/cauda or other neuromuscular or neurosensory malfunction from causes other than effects of local tumor growth or metabolic effects of tumor
Tumor must express Retinoblastoma (Rb) protein, as defined as any measureable staining by immunohistochemistry
Tumor foci detected below the tentorium
Tumor size of at least 5 centimeters
Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature
Confirmed RAS/RAF wild type tumor; paraffin-embedded tumor tissue obtained from the primary tumor or metastasis
Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy
Diagnosis of primary brain tumor
Tumor must be accessible for injection and must not be located in the brainstem or deep midbrain
If there is brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size < 1 cm^2) and the patient otherwise meets criteria for enrollment on the low-risk arm, the patient will be classified as low-risk
Amputation of the affected leg as treatment of tumor
Presence of measurable tumor
Vessels providing flow to the tumor that are less than 1.5 mm in diameter.
Subjects must have evidence of recurrent or metastatic carcinoma by one or more of the following:\r\n* The appearance of metastatic disease on chest x-ray or computed tomography (CT) scan\r\n* The appearance of rising tumor marker: AFP or beta-human chorionic gonadotropin (HCG)\r\nNOTE: if a rising tumor marker is the only evidence of progressive disease, at least 2 consecutive rising values at least one week apart are needed; subjects with only evidence of disease as rising tumor marker AFP and beta-HCG will be assessed for alternate causes of increased serum levels of these markers, such as cross reaction with luteinizing hormone (LH) (can be tested if needed by testosterone suppression of LH), hepatitis, use of marijuana, or second primary tumor
For subjects receiving adjuvant therapy only, subjects must have undergone complete resection of the primary tumor with clean surgical margins, or subjects must have undergone resection of the primary tumor and be scheduled for further treatment of the primary tumor with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
FDG avid malignancy\r\n* Patients must have an FDG avid tumor(s)\r\n* FDG avid tumors are defined as a primary tumor with an increased uptake in the region of the tumor that has an SUV of > 5.0 or a tumor:liver SUV ratio of > 1.5
Prior treatment with panitumumab for subjects with KRAS and NRAS wt tumor
Prior intolerance to fluoropyrimidine for subjects with KRAS or NRAS mut tumor
Accessible tumor that can be biopsied at acceptable clinical risk (as judged by the investigator) and must consent to pre-treatment and on-treatment tumor biopsies; tumor biopsy sites need not be distinct from evaluable lesions but must not have been irradiated prior to study entry
Patients must have at least one tumor accessible for intratumoral injection and EP on investigator's assessment.
Tumor foci below the tentorium or beyond the cranial vault.
The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
Radiation to primary tumor prior to enrollment in this study
Any treatment for the bladder tumor other than intravesical therapy between the pre-study cystoscopy or radiologic imaging which identified the suspected bladder tumor and the scheduled surgical removal or cystoscopy-guided biopsy of that tumor
The primary tumor must be in a location amendable to RFA within the kidney
There are no limitations based on location of the primary tumor within the kidney
Assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with NSCLC and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement
Location and extension of the tumor precludes an effective I-PDT
Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor
Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment
Clinical stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor; tumor must be >= 2 cm to provide adequate tissue
Histologically confirmed diagnosis of glioblastoma (after initial tumor resection or biopsy) with radiographic evidence of recurrent tumor per RANO criteria.
Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
Evidence of MCPyV TAg tumor expression
Tumor located in the supra-tentorial region of the brain
Unicentric tumor
Patients with =< 10 cc largest tumor volume, and =< 15 cc total tumor volume
The subject has a primary brain tumor
Patient must have radiologic demonstration of stable disease or tumor response
Tumor foci below the tentorium or or beyond the cranial vault
HER2-positive primary or metastatic tumor as assessed by central laboratory
Tumor biopsy specimen with ? 50% of MUC1 expressing tumor cells determined by Immunohistochemistry (IHC) staining on fixed pathological material. Biopsy may come either from the primary tumor or from a metastasis. Cytological material is not accepted for this analysis
Part 2 (surgical) patients only: patients must be undergoing surgery that is clinically indicated as determined by their care providers; patients must be eligible for surgical resection according to the following criteria:\r\n* Expectation that the surgeon is able to resect at least 100 mg of tumor from enhancing tumor and at least 100 mg from non-enhancing tumor with low risk of inducing neurological injury
Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):
Consent to provide archived tumor specimens
Patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least BED2Gy 60 Gy
Sarcoma or Wilms tumor diagnosis (Group C) will require evaluation by physician in the St. Jude Solid Tumor Division, other than the referring physician, attesting that autologous stem cell transplant (SCT) provides the prospect of direct benefit for the participant
HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central\n             laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)
Primary tumor and any positive node(s)measurable in 2 dimensions
Gastrointestinal stromal tumor (GIST)
Solitary fibrous tumor
PEComa (perivascular epithelial cell tumor)
Myoepithelioma / mixed tumor
At least one tumor that can be measured
Uncontrolled tumor in the brain
NET tumor other than PNET or GI-NET
Tumor must be glucocorticoid receptor positive TNBC (?10% positive cells by IHC of tumor biopsy)
Unknown primary tumor.
Infra-tentorial tumor
Subjects must provide tumor biopsies before treatment
Radiation to primary tumor prior to enrollment in this study
Tumor (primary or metastatic lesion) defined as MET-positive by IHC
HER2-positive tumor (primary tumor or metastasis)
Biopsy accessible tumor (may use archived tumor samples under certain circumstances)
For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included.
Calculated required PV-10 dose ? 15 mL (based on total tumor burden)
Direct tumor extension into aorta or pulmonary artery
Neurosurgical patient population in the City of Hope brain and spinal tumor neurosurgical programs that have been diagnosed with a brain tumor
Patients with any type of brain tumor will be eligible for participation
i2DOS will be attempted for all quantities, consenting, and brain tumor patients; we anticipate approximately 5 initial patients will need to be imaged before signal to noise parameters are optimized; then 1 patient from the most common operative tumor types (e.g. low grade glioma, glioblastoma multiforme, astrocytoma, invasive meningioma, metastatic breast carcinoma, etc.) will be imaged to ascertain gross intrinsic optical spectroscopically differences that may distinguish these tumors from each other and normal white matter, gray matter, and blood vessels
There are no exclusion criteria except for individuals without a brain tumor and the location of the craniotomy; if the exposed area of brain is not compatible with peripheral stimuli or volitional activity the subject cannot be enrolled
HER2-positive as assessed by local laboratory on primary or metastatic tumor
Patients with stage IV renal cancer\r\n* Patients in the initial cohort receiving CT-011 alone are not required to have tumor resection as a part of protocol participation\r\n* Patients in the second cohort are eligible if they are undergo therapeutic debulking nephrectomy for independent clinical indications OR patients with other sites of accessible disease as defined by peripheral lung nodules approachable by thoracoscopy, malignant effusions, or cutaneous, subcutaneous or superficial lymph node involvement; patients should have an independent diagnostic or therapeutic indication for this purpose; tumor tissue should be at least 1.0 cm in longest dimension to provide an adequate source of tumor cells for vaccine generation
Tumor that lacks both estrogen and progesterone receptors
Have at least one BCC tumor (greater than 4mm in diameter) at any skin location, which needs to be biopsied and surgically removed
Patients must have adequate tumor bulk accessible to biopsy in order to generate the tumor lysate (at least 2 cm diameter); procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous biopsies or open biopsies of readily accessible lesions; patients should not undergo biopsies, which will later compromise the ability to render function preserving local therapy (e.g. limb salvage therapy); to prevent this, all bone biopsies should be performed in consultation with the orthopedic consultant on the case; for patients with bone marrow involvement, bone marrow aspirates may be used as a source of tumor for tumor lysates; patients are not eligible if, in the opinion of the principal and associate investigators, tumor biopsy would entail extensive surgery such as thoracotomy or laparotomy, or if the tumor site places the patient a substantial risk from the biopsy procedure; National Cancer Institute (NCI) laboratory of pathology will review all tumor specimens for diagnosis
large tumor mass (bulky disease)
Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
An MRI must be used throughout the period of protocol treatment for tumor measurement
Tumor must be accessible for injection and must not be located in the brainstem, midbrain, contained within the ventricular system, or located in an infratentorial location.
May not receive other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from AdV-tk injection until tumor progression).
Other tumor histologies\r\n * Patients with tumor histologies not listed above will be considered on a case by case basis; to be eligible for this study, such patients must have an expected probability of survival =< 20% with other therapeutic modalities and must minimal disease criteria as defined in eligibility criteria
Patient is after surgical resection of the tumor where tumor was removed completely with surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen
Prior embolization, chemoembolization, or radiofrequency ablation permitted if >= 4 weeks from registration and evidence of new tumor growth is present
Subjects having had prior ablation therapy on the same tumor
Tumor thickness is 4 mm or less (in the judgment of the physician)
Radiologic suspicion of lung involvement (primary or metastatic), lymphangitic carcinomatosis, or airway involvement secondary to tumor infiltration.
able to provide adequate tumor tissue from at least 1 accessible tumor site
Uncontrolled tumor in the brain
Infra-tentorial tumor.
Any patient with a past medical history for a chronic disease (such as sickle cell disease), cancer (solid tumor, lymphoma, brain tumor) and have a current diagnosis which includes pain for which they are being treated, or currently undergoing bone marrow transplant – currently admitted to the hospital
Biopsy-proven neuroendocrine tumor with tumor burden dominant in the liver
Posterior fossa tumor/approach for tumor resection requiring the prone position
Systemic disease burden with metastatic tumor to the brain
SUBJECT: Children diagnosed with brain tumor in childhood.
Extremity or central axis (including craniofacial) primary tumor; localized or metastatic
Diagnosis of a primary brain tumor treated with at least one of the following:\r\n* Neurosurgical resection of the brain tumor\r\n* Cranial irradiation\r\n* Any chemotherapy to treat the brain tumor
Patients with stable metastatic disease which is defined as (metastatic tumor demonstrates no increase in volume, tumor size or diameter and no evidence of new lesions, have been identified during last assessment by medical oncologist/radiologist or surgeons)
In Arm 1, subjects must have residual visible tumor following TURBT. In Arm 2, subjects must be fully resected (i.e., no visible tumor or as little tumor as possible) after restaging TURBT 2-6 weeks prior to Study Day 0.
Tumor with known or expected RAS/RAF/MEK/ERK pathway involvement. Diagnosis must be one of the following tumor types: Central nervous system gliomas, including high- and low-grade gliomas, and diffuse intrinsic pontine glioma (DIPG) Embryonal rhabdomyosarcoma and other non-rhabdomyosarcoma soft tissue sarcomas Neuroblastoma Melanoma Malignant peripheral nerve sheath tumor Rhabdoid tumors, including atypical teratoid/rhabdoid tumor (ATRT) NF1-associated tumor (including plexiform neurofibroma), schwannoma, or RASopathy-associated tumor that in the judgment of the investigator is life threatening, results in severe symptoms (including severe pain), or is in close proximity to vital structures
Tumor bed is less than 5 mm from the skin surface
Patients with skin involvement, regardless of tumor size
Clinical or radiologic history of lung/pleural involvement (primary or metastatic), lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration
Patients with =< 10 cc largest tumor volume, and =< 15 cc total tumor volume
Diagnosed with one or more metastatic brain tumor(s)
Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx, subglottic larynx or unknown primary tumor
?1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure.
Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, salivary glands or unknown primary tumor
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)
Patients must be eligible for surgical resection according to the following criteria:\r\n* Part 1 Patients: Expectation that the surgeon is able to resect at least 350 mg of tumor from enhancing tumor and at least 350 mg from non-enhancing tumor with low risk of inducing neurological injury\r\n* Part 2 Patients: Expectation that the surgeon is able to resect at least 1000 mg from enhancing tumor and at least 350 mg from non-enhancing tumor with low risk of inducing neurological injury
Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
Eligible patients in the dose escalation phases of the trial must agree to biopsies of normal skin, unless they undergo optional tumor biopsies; the mandatory biopsy requirement can be waived at the discretion of principal investigator in the event of any medical contraindication (e.g. lidocaine allergy); patients enrolled to the expanded cohorts must agree to tumor sampling; patients on anticoagulation must be able to hold warfarin or low molecular weight heparin for a sufficient amount of time to make skin and tumor biopsies safe to perform; PT/INR and PTT should be =< 1.5 times the institutional upper limit of normal prior to performance of skin or tumor biopsies, with values re-checked after the eligibility screen as medically indicated
Histologic diagnosis of solid malignancy (excluding brain tumors and lymphoma) that meets at least one of the following criteria:\r\n* Refractory, defined as tumor progression after initiation of standard first line therapy without having achieved a prior partial or complete remission OR biopsy proven residual disease at the completion of planned standard initial front-line therapy\r\n* Recurrent, defined as tumor progression after achieving a prior partial or complete remission\r\n* Newly diagnosed high risk disease, defined as having an expected event free survival of < 50% at 2 years\r\n* Lacks definitive diagnosis or classical genomic findings after histologic review and standard molecular testing (rare tumor group)\r\n** Examples include (eligibility not limited to these examples): \r\n*** Histology typically associated with a fusion in which fusion is not detected \r\n*** Ewing-like sarcoma \r\n*** Undifferentiated sarcoma\r\n*** Inflammatory myofibroblastic tumor without ALK fusion\r\n*** Infantile fibrosarcoma without NTRK fusion
Pre-operative spirometry that suggests the patient cannot undergo resection of the primary tumor by segmentectomy, lobectomy, bilobectomy, or pneumonectomy
Children with a diagnosis of a brain tumor and who do not require sedation for MR imaging
Sufficient archived tumor material available (equivalent to 2 core biopsies or greater); if insufficient archived tumor material available new tumor biopsy is mandatory
Liver tumor ablation judged to be appropriate based on clinical assessment in the Brigham and Women’s Hospital (BWH) Tumor Ablation Clinic by the tumor ablation interventional radiologist, per standard clinical practice
(Part 2, intracranial tumor patients ONLY): Radiographical or pathological evidence of an intracranial tumor
(Part 2, intracranial tumor patients ONLY): Other chemotherapy (besides what is being used to treat the intracranial tumor)
Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.
Tumor(s) must be located near air cavities
Two adult patient groups will be eligible for inclusion in this study: \r\n* Group A: Patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present; pathologic confirmation will occur with biopsy or surgery; patients whose tumor is felt to be inoperable and a biopsy is performed but no surgery; patients with a newly diagnosed primary malignant brain tumor (World Health Organization [WHO] grade III or IV) who will be receiving chemoradiation and who either did not undergo surgical resection or underwent incomplete resection with residual tumor >= 1.0 cm in greatest diameter by contrast MRI postoperatively\r\n* Group B: Patients with pathologically proven malignant brain tumor (WHO grade III or IV glial-based tumors) who have undergone chemoradiation and have MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation
Subjects with a presumed diagnosis of brain tumor (based on imaging) or a confirmed brain tumor (based on pathology) before or after any oncologic treatment (surgery/chemotherapy/radiation)
Previous diagnosis of a brain tumor; patients who are either undergoing active treatment for a brain tumor or who have completed treatment will be eligible for study enrollment (Cohort 2)
No known endobronchial tumor
Inoperable tumor/nodule
Metastatic or primary malignant tumor involving spinal column, with or without extension into the epidural space
Intradural extension of the tumor
Patients undergoing a tumor resection at the University of Texas M. D. Anderson Cancer Center for a newly diagnosed primary or metastatic brain tumor located in or adjacent to motor brain areas
Tumor amenable to transcatheter arterial embolization
Histologically diagnosed or suspected (pediatric only) neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 2
At least part of the tumor must be visible as observed in a diagnostic or planning CT
Subject has undergone primary tumor resection prior to arrival at St. Jude
Tumor judged to be suitable for open cranial resection based on preoperative imaging studies
GROUPS 1, 2, AND 3: Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
History of mental retardation unrelated to brain tumor
Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor
Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma; supporting evidence may include MRI, CT, biochemical markers, and or pathology report
The tumor will be evaluated by both mammography and ultrasound
The tumor is visible and enhances on prone MRI
c-MET overexpression, ? 50% tumor cells with immunohistochemistry Grade 3+
MAGE-A3/A6 positive tumor
Subject's tumor has AFP expression of ?2+ in ?40% tumor cells by immunohistochemistry and their non-cancerous liver tissue has ?5% cells stained for AFP by immunohistochemistry.
Histologically proven: neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/ primitive neuroectodermal tumor, Wilms tumor, desmoplastic small round cell tumor or malignant solid tumors of any other histology that test positive for B7-H3 .
Must have malignant solid tumors that demonstrate B7-H3 expression at 2+ or greater levels on the membranous surface of at least 10% of tumor cells or ? 25% of tumor vasculature by IHC.
Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma; supporting evidence may include magnetic resonance imaging (MRI), CT, biochemical markers, and/or pathology report
ERUS tumor state of T1
1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be\n             included only at the first surveillance cystoscopy after a histologically confirmed\n             tumor. The histologically confirmed tumor could either be from a TURB or from a\n             surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by\n             histology)\n\n          2. History of one or more of the following:\n\n               -  Multiple tumors\n\n               -  Recurrent tumors\n\n               -  High grade tumor(s)\n\n        Exclusion Criteria:\n\n          1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed\n             resulting in significant amounts of blood in the urine, which may visually limit\n             cystoscopy. Where the haematuria is light, the patient should not be excluded, if in\n             the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will\n             alleviate the haematuria limitations to cystoscopy)\n\n          2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training\n             patients are eligible even if they cannot undergo operating room cystoscopy)\n\n          3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or\n             intravesical chemotherapy within the past 6 weeks prior to the procedure\n\n          4. Porphyria\n\n          5. Known allergy to hexaminolevulinate hydrochloride or a similar compound\n\n          6. Pregnancy or breast-feeding (all women of child-bearing potential must document a\n             negative urine pregnancy test before study inclusion and use adequate contraception\n             during the study\n\n          7. Participation in other clinical studies with investigational drugs either concurrently\n             or within the last 30 days\n\n          8. Patient is the investigator or any sub investigator, research assistant, pharmacist,\n             study coordinator, other staff or relative thereof directly involved in the conduct of\n             the protocol\n\n          9. Patients that the investigator believes are unlikely to comply with the protocol, e.g.\n             mental condition rendering the patient unable to understand the nature, scope, and\n             possible consequences of participating in the clinical study, uncooperative attitude\n             or unlikelihood of completing the study
Patient with rapidly evolving brain tumor that could change in appearance between the time of the two study MRI examinations.
Fresh frozen tumor, and/or paraffin block of biopsy or resected tumor is recommended, but not required to determine expression of somatostatin receptors in tumor by immunohistochemistry and/or quantitative polymerase chain reaction (qPCR)
Tumor sample shipped to Agendia with ? 30% tumor cells or that fails Quality Assurance or Quality Control criteria.
Patients with a new or recurrent, presumed or documented, diagnosis of primary or secondary brain tumor in or adjacent to eloquent brain areas (motor, supplementary motor area [SMA] and language) who are scheduled to undergo tumor resection
Patients with no previous therapy other than biopsy or surgical resection of the primary tumor; patients can have received pre-operative radiation to the primary tumor site, but cannot have received radiation directly to, or in close approximation of, the lymph node basin
Invasive malignant solid tumor of thoracic origin (e.g., lung, esophageal, thymus, mesothelioma, chest wall, mediastinum, trachea, pleura) with the intent to treat or biopsy by surgery as standard of care. Tumor must be >= 2 cm
Tumor judged to be suitable for open cranial resection based on preoperative imaging studies
Newly diagnosed breast tumor, female genital system tumor, colorectal tumor, and/or lymphoma/myeloma
Tumor invades a major blood vessel
Tumor treated with PDT within the last 3 months
Gastrointestinal stromal tumor (GIST).
A tumor with direct extension to the chest wall and/or to the skin.
Solid Tumor analyzed by Caris Molecular Intelligence™ Service Profile(s) and/or Caris\n             Next-Generation Sequencing
Subjects with tumor that directly contacts or encases a major blood vessel AND there is ulceration and/or fungation onto the skin surface
Subject must consent to pretreatment and on treatment tumor biopsies
Other chemotherapy or anti-tumor treatment for brain tumor (other than therapies required by the inclusion criteria of this protocol)
DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive is defined as staining in ?75% of tumor cells.
The patient must be willing to undergo a biopsy prior to treatment
The patient must be willing to undergo repeat biopsy at week 16 (for the first 20 patients in the phase 2 part of the study)
Patients with cutaneous or superficial lesions that do not require imaging guidance for biopsy must be willing to undergo biopsies for tissue submission and blood draws for translational medicine
Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study
For the expansion portion of the study: patients must have tissue that is amenable to biopsy and must be willing to undergo research biopsy; patients who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
Be willing to undergo percutaneous endoscopic gastrostomy (PEG) placement, if necessary
Willingness to undergo serial tumor biopsies before and on treatment
Cohort A Dose Expansion (Ribociclib + PDR001): Participants with accessible tumor lesion(s) must be willing to undergo two research biopsies: one prior to treatment initiation and one after 7 weeks of protocol therapy; participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy; they will not be required to undergo a repeat research biopsy attempt
Expansion Cohort B (Ribociclib + PDR001 + Fulvestrant): Participants with accessible tumor lesion(s) must be willing to undergo two research biopsies: one prior to treatment initiation and one after 7 weeks of protocol therapy; participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy; they will not be required to undergo a repeat research biopsy attempt
Subjects enrolling to the phase 1 portion of the trial who have received a prior RET TKI must be able and willing to undergo a pre-treatment fresh tumor biopsy
Subjects enrolling to cohort B or C of the phase 2 portion of the trial who have received a prior RET TKI must be able and willing to undergo a pre-treatment fresh tumor biopsy
Participants enrolling in the dose expansion must have tissue that is amenable to biopsy and be willing to undergo a fresh tissue biopsy at baseline; participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
Willing and able to undergo a pre- and subsequent on-treatment bone marrow biopsies
Be willing and able to undergo a core or excisional tumor biopsy according to institutional standards (guided visually or by computed tomography [CT] or ultrasound), paracentesis, or thoracentesis for tumor cells \r\n* Note: This is to be done prior to treatment at C1D1 and post-treatment (cycle 2 day 8), if this is clinically and safely feasible to do so; this will allow the use of this freshly obtained tissue for correlative analyses in the study
Patient is willing to undergo a fresh tumor biopsy (core or excisional) for correlative analyses (ie. PD-L1 expression)
For participants enrolling the phase IIa part of the study, accessible tumor lesion(s) for the purpose of research biopsy and willingness to undergo a research biopsy before treatment initiation and at the time of disease progression, as well as a single research blood sample before initiation of therapy; participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy; they will not be required to undergo a repeat research biopsy attempt
Biopsies:\r\n* Cohorts B and C: all patients with disease that is deemed by the treating investigator as safely accessible to biopsy are required to undergo research biopsies as outlined in this protocol\r\n* Cohort A: such biopsies are optional
Parts H, and I: Must be able and willing to undergo mandatory tumor biopsies prior to study treatment and at the time of discontinuation from study treatment.
DONOR: Willing to undergo multiple apheresis procedures (except donors < 12 years who will undergo bone marrow harvests)
Be able to undergo protocol therapy, including necessary surgery.
Participants must be able and willing to undergo a pre-treatment tumor tissue biopsy; participants must also be willing to undergo an on-treatment tumor tissue biopsy if clinically feasible
Must be able and willing to undergo mandatory tumor biopsy.
Agrees to undergo a pretreatment and a post-treatment biopsy.
Is willing to undergo a mandatory pre-treatment research biopsy
Participants must be willing and able to undergo a biopsy at the start of this study and an on-treatment biopsy if safe and feasible
Patients must be able to undergo appropriate imaging studies to monitor tumor response
The participant must be willing to undergo the three required research biopsies over the course of protocol therapy; participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
Patient must be willing to undergo breast biopsies as required by the study protocol.
Participants enrolling to the MET cohort who have received treatment with a prior MET inhibitor must be able and willing to undergo a baseline tumor biopsy
Participants enrolling to the NTRK cohort who have received treatment with a prior NTRK inhibitor must be able and willing to undergo a baseline tumor biopsy
Part A and Part B: Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies.
Patients must be willing and able to undergo study required biopsies.
Must be willing to undergo definitive resection with neck dissection.
Patients enrolled in the expansion phase must be willing to undergo pre and post-Cycle 1 biopsies.
Patients must have a PN amenable to a percutaneous biopsy to participate in the biopsy portion of this study, and must be willing to undergo pre-, and on treatment tumor biopsies; there should be no contraindication for serial biopsies; NOTE: up to 10 patients who meet all criteria, but have PN which cannot be biopsied safely, will be eligible for the treatment portion of the study
Willingness to be evaluated for surgical placement of an intraperitoneal port and undergo biopsy if feasible for a research sample
Willingness to undergo a tumor biopsy at baseline and at disease progression
Patients enrolling in the expansion cohorts must have disease amenable to biopsy and be willing to undergo pre-and post-treatment biopsies
Participant must be willing to undergo a pre-treatment screening biopsy for enrollment and subsequent biomarker analyses.
Willingness and ability to undergo mandatory tumor biopsy at baseline
Willingness and ability to undergo mandatory whole blood sample collections at baseline
Willing to undergo mandatory biopsy at screening and on treatment. Part A only: the first 3 subjects in each cohort are exempt from this requirement.
Subjects must be willing to undergo a cystoscopy.
Subjects must be willing to undergo a biopsy for assessment of clinical response.
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory biopsies
COHORT 3: ENDOMETRIAL CANCER: Patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory biopsies
Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
Willing to undergo a new core or excisional biopsy from a metastatic, not previously irradiated tumor lesion during screening
Patients must have at least one tumor amenable to serial biopsy in clinic or be willing to undergo serial biopsies through image-guided procedures during the neoadjuvant phase of the protocol. Patients must be willing to provide tumor samples at the time points.
In dose expansion, patients must be willing to undergo a pre-treatment biopsy, and four research PET imaging techniques (11C-Glutamine and 18F-FSPG), two pre-treatment and two after one cycle of treatment
Willing to undergo the intra-tumoral (IT) injection of the poly-ICLC into the prostatic tumor as per the protocol
For the Western safety cohort only: willingness to undergo serial skin tissue biopsies.
Willingness to undergo a fresh tumor biopsy pre-treatment and on treatment, if deemed safe and feasible by treating oncologist.
Patients who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy or paracentesis for tumor cells before therapy (at baseline) and after initiation of treatment (before cycle 2) for all subjects if this is clinically and safely feasible to do so
Willingness to undergo research biopsy
Patients must consent to pre and on treatment research biopsies
Patients must have at least one focus of metastatic disease that is amenable to pre- and on-treatment biopsy and be willing to undergo this; ideally the biopsied lesion should not be one of the target measurable lesions, although this can be up to the discretion of the investigators
Patient must be willing to undergo two biopsies- before and on-treatment, provided the procedure is not deemed high-risk and is clinically feasible
Participants must have disease amenable to and be willing to undergo serial core or excisional biopsies of a tumor lesion(s)
Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes; a second post-treatment biopsy will be offered but will not be mandated
Willingness to undergo paired tumour biopsies during the trial.
Physiologically able to undergo HIPEC and gastrectomy
DONOR: Able and willing to undergo apheresis
Willing and able to undergo bone marrow aspiration and biopsy tissue sample collection during screening and on study
Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2 only)
Be willing to undergo normal skin biopsy prior to initiation of treatment and after treatment
Is medically able and willing to undergo needle biopsy of a tumor lesion; PD-L1 expression is not required to enroll in the trial
Willing to undergo core biopsies for research at study entry and at ~4 weeks
Willingness to undergo core biopsy of primary hepatic tumor prior at baseline and again at cycle 2 day 1
PHASE II: Patients must have measurable disease according to RECIST 1.1 criteria that is amenable to biopsy and be willing to undergo pre- and post-treatment tumor biopsies; lesions to be biopsied do not have to be those used for measurement
Willing to undergo a biopsy of a metastatic site of breast disease for central laboratory determination of ER and correlative research purposes
Patients must be able to provide blood and marrow samples and to undergo the procedures required for this protocol
mCRPC EXPANSION COHORT: All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
Be willing to undergo tissue biopsies as mandatory as per protocol for patients with biopsy accessible disease
Cohort Expansion: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour biopsy on treatment. Where possible, tumour lesions used for new biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy. Archival samples may be required if there is inadequate tissue in the biopsy specimen.
Consent to undergo a fresh biopsy in case of benefit from therapy and subsequent progression
Patients must be willing and able to undergo biopsy according to the institute’s own guidelines and requirements for such procedures
Patients who do not undergo chemotherapy
Group 2: consent to undergo research biopsies
Note: Subjects who are unable to undergo pre-dose (screening biopsy) will not be eligible
Willingness to provide informed consent to undergo pre- and post-dose biopsy
Patients must be healthy enough to undergo a general anesthetic
All participants will be required to undergo mandatory pre and on-treatment biopsies
Must undergo a new tumor biopsy for acquisition of resistant tumor tissue; subjects unable to undergo a new tumor biopsy are not eligible for Part B
Patients must be willing and able (in the opinion of the treating physician) to undergo two research biopsies for the investigational component of this trial
COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI
Patients must undergo pre-treatment direct laryngoscopy (DL) endoscopic tumor staging and CT scanning
Patients must be willing to undergo 2 tumor biopsies
Able and willing to give informed consent, and to undergo staging including PET scanning
Willingness to undergo a pre-treatment and on-treatment tumor biopsy to obtain the specimen.
Willingness to undergo MDACC Audiology and Ophthalmology Assessment
Participants willing to undergo all protocol-specified biopsies
Willingness to undergo a tumor biopsy prior to treatment.
Willingness to undergo a tumor biopsy while on study treatment.
Willing to undergo biopsy of a metastatic lesion at the time of progression
Willing to undergo multiple cystoscopies during the study for TAR-200 removal and post-insertion examination.
Deemed eligible for and willing to undergo RC by the attending urologist.
Patients must be willing to undergo additional radiologic imaging while on study
Measurable disease according to RECIST v1.1, and willingness to undergo a total of 2 biopsies of a primary or metastatic tumor site(s) considered safely accessible for biopsy.
Willing to undergo routine surveillance with breast ultrasound and/or mammography
Patients whose clinical biopsies are found to be insufficient for the planned translational studies must be willing to undergo a research biopsy.
Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for research purposes
Subjects in expansion cohort only: Willing to undergo pre- and on-treatment biopsies
Patient must state willingness to undergo pre- and post-treatment biopsies. According to the investigator’s judgement, the planned biopsies should not expose the patient to substantially increased risk of complications
Willingness to undergo fluoroscopy-guided SGB or sham treatment
Subject must be willing to undergo protocol directed biopsies and blood draw for immune profiling
Willing to undergo pharmacogenetic testing
Subjects must agree to undergo two research-directed biopsies during treatment
Subjects must be able and willing to undergo serial biopsies of injected lesion(s) and, when applicable and clinically feasible, non-injected lesions
Willing to undergo tumor biopsies from injected and distal lesions
Presence of biopsiable disease and patient able to undergo pre-treatment and on-treatment biopsy
Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy for tumor cells before therapy at cycle 1, day 1, and day 8 (before cisplatin dose) if this is clinically and safely feasible to do so
Patients must be willing to undergo 2 tumor biopsies
Ability to undergo up to 90 minutes of PEM imaging
Patient must be willing to undergo mandatory research biopsy and blood draw; prior to biopsy procedures patients must be able to be off medications that could increase the risk of bleeding
Be willing to undergo a second core or excisional biopsy of a bone metastasis on therapy (approximately after 8 weeks of study therapy or after 2 doses of radium-223 if delays have occurred)
DONOR: Able and willing to undergo apheresis
Ability and willingness to undergo repeat tumor biopsies (the biopsy is optional and only applicable to subjects considered for the expansion cohort stage of the study)
Willing to undergo testing for gBRCA.
Patient must agree to undergo central tumor HRD testing
Subjects enrolling in the primary refractory or relapsed melanoma must be willing to undergo mandatory pretreatment and on-treatment biopsies.
Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
Must be willing to undergo tumor biopsy at study entry for biologic correlates.
If patient > 18 years, must be willing to undergo on-treatment tumor biopsy unless medically contra-indicated
Willingness to undergo a pretreatment and on-treatment tumor biopsy to obtain tumor tissue.
5. Subject who is willing and able to undergo biopsy.
Patient must be willing to undergo biopsies as specified by the protocol; the biopsy requirement can only be waived if deemed unsafe by the patient’s treating physician or the principal investigator (PI)
Subject must undergo mandatory biopsies, including one pretreatment and one post treatment tumor biopsy procedure
Subject must agree to undergo two research-directed biopsies during treatment
Willing to undergo breast core biopsies as required by the study protocol
Subject is willing and able to undergo biopsy.
Willingness to undergo a tumor biopsy
Availability of archival (diagnostic) specimens and willing to undergo a pre-treatment biopsy.
Willing to undergo endoscopic evaluation with biopsies in compliance with this protocol
Inability to undergo two sequential EUS-directed core biopsies of the primary tumor (for Immune Response Cohort only)
Patients will have at least one melanoma deposit that can undergo serial biopsy (at least 2 time points) during the neoadjuvant phase of the protocol; patients must be willing to provide tumor samples at the time points specified in the Study Procedure Tables
ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS 1 AND 2): Patients must be able to provide blood and tumor samples and undergo the procedures required for this protocol
Presence of biopsiable disease and willingness to undergo pre-treatment biopsy
Subjects should be willing to undergo a research related biopsy prior to treatment and at the time of progression
Willingness to undergo a tetanus vaccination
Willingness to undergo pre- and on-treatment biopsies unless not clinically feasible while on treatment
Willing to undergo biopsy for research purposes only; Note: if possible, the pre-treatment biopsy should be performed after all other eligibility criteria are confirmed
DONOR: Able and willing to undergo apheresis
Willingness to undergo tumor biopsy
Tumor tissue requirements: Availability of archival tissue, or willingness to undergo fresh biopsy at baseline; Enrollment in PK/PD cohort may be limited to subjects with disease amenable to pre- and post-dose biopsies, and willingness to undergo biopsy.
Patients may undergo an optional biopsy of the metastatic disease at baseline and after 2 cycles of BIBF-1120
Willingness to undergo leukapheresis and biopsy procedures for the autologous components (peripheral blood mononuclear cells, plasma and fresh tumor specimen) required for manufacture of AGS-003
Patient must be willing to undergo surgery at MUSC within 4-8 weeks of completing chemoradiation
Patients on stage 2 of the enrollment must have tumor sites that are easily biopsied and be willing to undergo pre- and post-treatment (around day 8 +/- 3 days) tumor biopsies
Patients on the Phase II portion only must be willing to undergo pre- and post-treatment biopsies and have at least one lesion amenable to biopsy
For Part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
Willingness to undergo pre-treatment and on-treatment biopsy.
Willing to undergo post-NAC, pre-treatment biopsy for research purposes only, and to allow surgical tissue sample from definitive surgery to be used for research purposes
Willingness to undergo two tumor biopsies: before and after administration of RO7070179.
Study patients must have disease that is amenable to pre and post treatment biopsy and be willing to undergo this
Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
Patients may choose to undergo an optional tumor biopsy including collection of research blood samples pretreatment and at weeks 3 and 15
Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.
If the maximum number of non-biopsy subjects has accrued to the study, willingness to undergo 2 tumor biopsies. NOTE: Tumor biopsies may be required, depending on the number of subjects who have agreed to undergo correlative studies.
For certain subjects, willing and able to provide pre- and post-treatment fresh tumor biopsies
Participants with accessible disease must be willing to undergo a research biopsy before beginning crossover therapy
Willing to undergo phlebotomy
Willing and able to undergo study assessment
Able to undergo a 4-hour (h) intrathecal catheter placement
Eligible for and willing to undergo RC per the attending urologist.
Willing to undergo tumor biopsy
Are to undergo laparotomy
Patients undergo recanalization procedure of tumor during bronchoscopy
Patients unable to undergo routine endoscopy with biopsy
Patient has been recommended to undergo and plans to have a prostate biopsy
Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
Willing to undergo study measurements
Willingness to undergo screening tests and procedures
Willing to undergo study measurements
Willingness to undergo screening tests and procedures
Participants must be able and willing to undergo a bronchoscopy before and after treatment for 6 months
Willingness to undergo tumor biopsy prior to initiation of treatment
Willingness to undergo radiotherapy.
Patients must be willing to undergo mandatory research biopsy
Patients must be willing to undergo mandatory research biopsy
Patients cannot undergo CT examination.
Able and willing to undergo anal cytology, anal molecular testing, and high resolution anoscopy with targeted anal biopsies
Subjects must be willing to undergo surgical biopsy and/or resection of indeterminate pulmonary nodule(s)
Patients who are planning to undergo treatment in a different institution
Willingness to undergo biopsy
Patients who cannot undergo MRIs
Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
Patients must be willing to undergo a biopsy of the prostate
Patients must be willing to undergo serial imaging procedures
If planning therapeutic systemic therapy, willing to undergo biopsy for research purposes only after drug dosing in LCCC1214
Fit to undergo all procedures listed in protocol
Unfit to undergo any procedures listed in protocol
Eligible subjects must be able and willing to undergo the procedures of the study
Willing and able to undergo all study procedures
Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study Visit 1.
Willing to undergo 1 baseline and 1 posttreatment tumor biopsy procedure.
Patient must be willing and able to undergo the imaging studies outlined in the protocol.
Subjects must have a tumor lesion that is amenable to an image-guided core biopsy and willingness to undergo two biopsies (baseline and 6 weeks after first dose of study treatment).
Tumor amenable to biopsy and willingness to undergo tumor biopsies before and after M6620 (VX-970) treatment during the expansion phase of the trial (biopsies optional during the escalation phase)
During the expansion phase of the protocol, patients must have disease amenable to biopsy and be willing to undergo pre- and post-treatment biopsies