At least two sites of biopsy for those cases where mammographic extent of calcifications exceeds  cm, with second biopsy benign or both sites fulfilling pathology eligibility criteria
Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL within  weeks of confirmatory imaging study
Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed within four () months prior to randomization\r\n* If biopsy was performed as part of patients standard care, and will not be performed during step  proceed directly to randomization
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.
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)
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 CD and post-treatment (cycle  day ), 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 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  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 - 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  years must undergo a fresh tumor biopsy or should receive approval for enrollment from the principal investigator
Must have biopsy-proven desmoid tumor (or aggressive fibromatosis). For patients with recurrent disease, a biopsy is not required at the time of recurrence
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  days of beginning ONC) and at least  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  lesion amenable to the mandatory fresh tumor biopsy at study entry and provide a biopsy suitable for the NGS required for this study.
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  mg/day prednisone, or equivalent, for a maximum of  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.
Sufficient tissue from diagnostic tumor/ lymph node biopsy (from within  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.
Availability to provide a representative tumor specimen biopsy
Women with surgical breast biopsy(s) performed within  years or core biopsy(s) performed within  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  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
Has ? distant, discrete non-injected lesion which is amenable to biopsy.
HSIL cytology with no invasive features identified on colposcopy or the baseline biopsy
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 participants primary tumor is accessible to biopsy in the outpatient clinic setting and the participant is willing to have baseline and end of study (day -)  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 \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  and , 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.
Participants core biopsy slides suggest that later re-sectioning will not contain sufficient tumor to allow for an adequate evaluation of Ki and TUNEL assays, at a minimum
Participants enrolling to the HR or replicative stress cohort during stage  may not be on anticoagulant therapy unless the treating investigator has deemed it safe to temporarily hold to facilitate the pre-treatment tumor biopsy.
Patient is able to provide tissue from diagnostic core biopsy of tumor lesion(s)\r\n* Notes:\r\n**  cores may be taken for lesions > . cm, otherwise  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 a dose escalation combination cohorts must have at least  tumour lesion amenable to biopsy and must be medically fit and willing to undergo a biopsy during screening and, unless clinically contraindicated, after  weeks on monotherapy.
Presence of >=  tumor lesion not included as a RECIST . 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
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)
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- will be discontinued.
Consent for a tumor biopsy at screening
All patients except cohort  must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy; for cohort , the second biopsy at progression is mandatory for the responders (PR/CR/stable disease [SD]) >=  months
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
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  sets of core needle biopsies (pre-treatment and at - 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-L IHC testing; an optional core biopsy will be requested at progression (Stage  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
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 physicians discretion and include patients with advanced stage disease considered at low likelihood for optimal cytoreduction with primary debulking surgery.
Pathologic confirmation of respective malignancies; biopsy of metastatic disease is preferred but not mandatory
Biopsy with less than % 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 TM status has already been determined using a local assay)
At least  days from any major surgeries including brain biopsy and have complete resolution of its effects
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  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  days from any major surgeries including brain biopsy and have complete resolution of its effects
Mandatory biopsy on study entry, if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator)
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 RPD biopsy expansion cohort only), and agree to undergo a pretreatment and on-treatment biopsy.
For disease-specific cohort participants: Must have an archival (banked) tumor sample or agree to have a new (fresh) tumor biopsy during the screening period. If a new tumor sample is needed, the disease should be accessible for a nonsignificant risk biopsy procedure (those occurring outside the brain, lung/mediastinum, and pancreas, or obtained with endoscopic procedures not extending beyond the stomach or bowel). For participants in the Western safety cohort, this biopsy is optional.
Is willing to provide archival tumor tissue from a biopsy performed within  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  days prior to study drug administration.
Disease that can be safely accessed via bronchoscopic, thoracoscopic or percutaneous biopsy, and willingness to undergo biopsy before and after 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
Advanced, solid tumor malignancy that is amenable to biopsy; patient must consent to  mandatory biopsies during study
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
Pathological diagnosis should be obtained by incisional or excisional tissue biopsy; core biopsy is only permissible if obtaining an incisional or excisional is not possible and if the grade can be assessed on the core biopsy
Tumor deemed amenable to biopsy by core for metastatic site or endoscopic biopsy for primary tumor (for both before and on-treatment biopsies)
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) .; 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 - cm
Available tissue from prior biopsy (minimum of  unstained slides), or willing to undergo core biopsy to obtain tumor material. Biopsy will be mandatory for patients with recurrent disease
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
Positivity on CD assay as defined by strong (+++) or moderate (++) staining in % or more of the tumor tissue/stroma as obtained by biopsy or paracentesis
Positive serum anti-poliovirus titer >= : prior to biopsy
Tumor blocks available from previous surgery/biopsy, or if not available, patients willing to have biopsy
Prior therapy for DLBCL, with the exception of nodal 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 >= % of the tumor
Baseline skin biopsy taken within  months available for central review submission
Subject that underwent excisional biopsy of the primary tumor.
Subjects must be able to provide tissue from - separate biopsy procedures that will be completed throughout the course of the study; day  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  weeks prior to initiation of treatment on day ; there should be no intervening treatment in between the pre-study biopsy and day ; day  biopsy: required; day  biopsy: required
Creatinine =< . x normal range prior to biopsy
Positive serum anti-poliovirus titer prior to biopsy
Patient must consent to two mandatory biopsies and have tumor amenable to biopsy
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  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  weeks of starting initial therapy; a minimum of  um slides or block is required
Adequate archival tissue must be available from the prior  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 . x . cm in size or contain at least  tumor cells
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 >=  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
The patient must consent to a research biopsy at baseline, and during week  of cisplatin-IMRT; all patients will be evaluated for the feasibility of research biopsy at the time of enrollment, as a condition of eligibility; the performing physician must agree that a cup forceps biopsy or an  to  gauge core needle biopsy can be safely performed; every effort will be made to couple the baseline research biopsy to a standard of care diagnostic or staging procedure; NOTE: patients who have had research tissue procured under an omnibus tissue consent, who are determined to have sufficient fresh, fresh-frozen, and paraffin tissue for analysis of immune-inflammatory biomarkers per the translational science co-chair, may substitute the archived tissue and do not need to undergo baseline research biopsy; such tissue must have been obtained within the prior  weeks and no interval anti-cancer therapy administered
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  days of first planned drug dose
Paired, pre- and post-treatment, tumor biopsy is optional for subjects enrolled in the Dose Escalation and Food-effect cohorts
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 < years prior to enrolment if a new tumour biopsy is not feasible with an acceptable clinical risk.
Dose Expansion Cohort Group  and : 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  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
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)
Willingness to provide a fresh biopsy prior to study enrollment and after  cycles of treatment as clinically appropriate per PI discretion
Patients with documented HER-positive metastatic disease based on most recent biopsy
Biopsy containing ?  tissue cores sampled
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 ? months for biomarker analysis. If bone marrow biopsy was performed  months before screening but subject had anti-cancer treatment after biopsy, the bone marrow biopsy and aspiration should be repeated CLL Participants:
Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor 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
Adequate archival tissue for determination of EGFR-mutation status and PD-L status with a leftover cell block (or equivalent) for additional immune correlates from a tumor lesion biopsied in the last  days that has not been previously irradiated occurring: ) after progression on erlotinib and no intervening systemic treatment between biopsy and initiation of MK- and afatinib or amenable to repeat biopsy
Diagnosis must be made by biopsy or excision
Tumor blocks available from previous surgery/biopsy, or if not available, patients willing to have biopsy
Submission of tumor samples from the diagnostic biopsy and breast surgery is required for all patients
Subject has no tissue from UPCC 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]- 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 -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 >  months duration), refractory (no response to last treatment or response duration <  months) or residual Hodgkin lymphoma; NOTE: re-biopsy is necessary unless the patient has had a previous biopsy <  days prior to registration on this protocol with no intervening therapy and tissue is available for translational research studies
Subjects will be required to agree to a biopsy performed at baseline and again at week  of the study in order to be eligible for enrollment in stage  of the study
Patient amenable to liver tumor biopsy
Archival tissue ( unstained slides -  micron sections) from a core biopsy performed and received within  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  of the study
Patients must agree to have a biopsy at baseline and on treatment
cMet expression in >= % tumor cells as demonstrated on immuno-histochemistry analysis of archival slides; punch biopsy or percutaneous core biopsy may be offered to Cohort  patients
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  weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator.
Core biopsy, including bone marrow biopsy, within  days prior to study drug administration
Patients must have at least two sites of disease amenable to biopsy
Baseline tumor biopsy must be adequate
Is not expected to be available to receive study drug within  weeks from the time of baseline biopsy for any reason
Patients must have measurable metastatic disease amenable to biopsy; patients who decline to undergo a biopsy for this trial will be ineligible
RENAL COHORT: Patients with an outside biopsy within  months is allowed for entry requirements; during the screening phase, patients without a tissue diagnosis may undergo a renal biopsy for histologic confirmation on PA-
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  on-treatment biopsies will be required for a minimum  patients. After  paired biopsies have been obtained then week  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
Tumor site amenable to a) excisional biopsy or b)  core biopsies from two lymph node sites ( cores total) or other surgical procedure to provide adequate lymphoma sample for TSMA sequencing and screening.
Patients must have biopsiable tumor and agree to study biopsy
The patient must have measurable disease according to RECIST v. 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 (>= 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  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
IDH/ mutation in any prior biopsy
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  months prior to registration on MPACT and providing that the patient has not received any investigational or targeted treatment since that time
TUMOR BIOPSY SEQUENCING: Platelets >= ,/uL (mcL)
TREATMENT: Patient must have predefined targeted mutation in tumor biopsy
Inability to test core biopsy for study markers
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  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  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  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
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  weeks ( days) prior to initiation of treatment on day ; 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
Transrectal ultrasound-guided biopsy with >=  systematic biopsy cores and >=  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  + 
Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review)\r\n* Minimum of  biopsy cores\r\n* Gleason score  or \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)
Pre-surgery tumor deemed amenable to core biopsy (with at least  mm^ tumor volume per biopsy)
Patients must be willing and able to undergo a pre-surgery biopsy and wait  weeks before their debulking surgery; NOTE: consented patients with subsequent inadequate biopsy material will not receive INCB or be analyzed and will be replaced; the study will be stopped if adequate tissue is not obtained in more than / of paired samples with a maximum accrual of  patients
Excisional biopsy or lumpectomy performed prior to randomization
Patient must agree to allow  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  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  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 =< mm 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 <  cm in diameter have a low likelihood of being malignant and should be followed; lack of growth over - years suggests it is not HCC\r\n* Alpha-fetoprotein (AFP) >  and radiological evidence (arterial hypervascularity) of lesion >  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
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
For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
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  days prior to start of treatment and the second biopsy while on treatment)
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
Submission of original biopsy for review by hematopathologist at local institution
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
T patients need to have evidence of muscle included in their latest biopsy; and if not a re-TURBT has to be done prior to enrollment
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
Patients enrolled in the expansion stages must agree to a tumor biopsy to be obtained during the screening period and during Cycle  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  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 % of their tumor removed
All patients must undergo a baseline tumor biopsy for programmed cell death ligand  (PD-L) testing (PD-L positivity is determined by greater than or equal to % of cells staining in the membrane by immunohistochemistry); for patients with stage IV disease, site of tumor biopsy will preferably be from non-lymph node disease site; the - clone for PD-L testing is required for assessment of PD-L status; for PD-L testing, the biopsy should contain sufficient tumor content (>=  tumor cells/-micron tissue section); if a sample contains insufficient tumor content, a re-biopsy will be required to obtain a sample with sufficient tumor content prior to treatment
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  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 patients 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  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  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
Patients must consent to a research biopsy of tumor tissue at baseline, for conduct of correlative studies; archived biopsy material may not be substituted
Patients must agree to undergo two research biopsies of a malignant lesion; patients may be exempt from biopsy if ) the investigator or person performing the biopsy judges that no tumor is accessible for biopsy, ) the investigator or person performing the biopsy feels that the biopsy poses too great of a risk to the patient, or ) the patients platelet count is < ,/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 v. response evaluation, then the patient may be exempt from biopsy; the goal will be to have a minimum of  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  of  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  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
Patients must agree to have a biopsy at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator)
All patients with disease technically amenable to biopsy will be asked to undergo a biopsy; patient must agree to allow  biopsies of any malignant lesion that can be accessed by endoscopy or with the aid or radiology (i.e. CT guided)
For the phase  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 patients 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 institutions 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 # is optional
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 (st and nd biopsy; rd biopsy is optional)\r\n* For inaccessible tumors availability of tissue is required: >=  tumor containing formalin-fixed paraffin-embedded (FFPE) slides/sections; - ideal
Diagnosis must be made by surgical biopsy or excision
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 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
Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone
Positive serum anti-poliovirus titer prior to biopsy (except for retreatment)
Creatinine =< . x normal prior to biopsy
Duodenal cancer on biopsy.
Consent to biopsy of tumor
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 =<  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
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 ) the investigator or person performing the biopsy judges that no tumor is accessible for biopsy, ) the investigator or person performing the biopsy feels that the biopsy poses too great of a risk to the patient, or ) the patient's platelet count is < ,/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 v. 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
Core biopsy should definitively demonstrate invasive carcinoma
Patient must be at least two weeks post any brain surgery (whether stereotactic biopsy, open biopsy or resection) at the time of randomization
Must consent to allow the acquisition of new tissue biopsy samples during the study
Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma according to the American Association for the Study of Liver Diseases Guidelines.A biopsy performed at screening may serve as a diagnostic biopsy for subjects with radiographic diagnosis.
Willing to undergo or must have had a lower GI biopsy within  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 , has archived or fresh tumor biopsy samples (obtained during screening) sufficient for genotyping.
Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study
Biopsy-confirmed histopathological diagnosis of FL. Biopsy specimen should be obtained ? years prior to randomization, unless medically contraindicated
Patients must have disease amenable to biopsy and must be medically fit to undergo a biopsy
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-
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
Disease amenable to biopsy and agree to undergo biopsy for molecular analysis
Willingness to provide at least one pre-and post-vaccination tumor biopsy sample.
Biopsy proven plasmacytoma. Prior biopsy is acceptable.
Availability of a representative tumor specimen. Patients enrolled in Arm  of Phase II must have disease sites amenable to biopsy unless prior agreement between Novartis and the Investigator.
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  days prior to Cycle /Visit Day ;
At least % of cells >= + for FRa staining based on diagnostic (i.e., prior to NAC) tumor biopsy
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 (rd) CDX- injection; additionally, the first  patients enrolled must consent to a third tumor biopsy to be performed after the rd MPDLA infusion
Tumor tissue submitted for molecular and genetic analysis through the companion Stand-up  Cancer (SUC) 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
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 .  . cm in size or contain at least  tumor cells.
By tumor biopsy if conducted within  weeks of randomization.
Excisional biopsy
Arm  only: At least  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
Available tumor site amenable to core needle biopsy as determined by the treating investigator; any questions regarding suitability of site for biopsy will be adjudicated by the principal investigator
Availability of an existing tumor biopsy sample (or consent to allow pre-treatment tumor biopsy if sample not available)
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)
Willing to take drug during the - weeks between biopsy and surgical removal of BCC
No prior treatment (patients on \watch and wait\ may enter the study if a recent biopsy [obtained within the last  months] is available)
Prior to enrollment on ANBL, a determination of mandatory disease staging must be performed (tumor imaging studies including computed tomography [CT] or magnetic resonance imaging [MRI], MIBG scan, and vanillylmandelic acid [VMA]/homovanillic acid [HVA]; bone marrow aspirates are required but biopsy may be omitted if negative prior to ASCT); this disease assessment is required for eligibility and should be done preferably within  weeks, but must be done within a maximum of  weeks before enrollment\r\n* For those with residual disease before radiotherapy, re-evaluation of irradiated residual tumors is preferably performed at the earliest  days after completing radiotherapy; patients with residual disease are eligible; biopsy is not required; patients who have biopsy proven residual disease after ASCT will be enrolled on Stratum \r\n* Patients must not have progressive disease at the time of study enrollment except for protocol specified bone marrow response and except for elevations of catecholamines as the only sign of disease in a patient who had normal catecholamines at pre-ASCT evaluation
Phase II: The initial  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  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 ?% of cancer in any biopsy core,
Has ?  mm of cancer in any biopsy core,
Has ? % positive biopsy cores
Woman histologically diagnosed by an open biopsy procedure
Has provided tissue for Programmed Cell Death Receptor Ligand  (PD-L) 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 T 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 PIKCA 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 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.
Subjects must consent to allow for the acquisition of tumor sample prior to starting treatment on study (in most cases patients will require a tumor biopsy); this biopsy site may be the only site of measurable disease if the site is >  cm; the biopsy site must, in the opinion of the investigator, be likely to yield acceptable tumor sample for core biopsies; it is also acceptable if tumor sample is obtained by excision biopsy or during surgery (i.e. if procedure was previously planned), provided the tumor sample can be processed; in the case that a patient had a tumor sample acquired prior to consenting to the study and this tumor sample is acceptable for processing (i.e. frozen sample stored) and the tumor sample was acquired within  days of starting treatment, this is acceptable and a new biopsy will not be required
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
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  months of biopsy
Imaging sets in which a biopsy was recommended, but biopsy was not performed and -year imaging follow-up is not available
Women who have a core biopsy or excisional biopsy containing invasive cancer
Pre-intervention biopsy sample collected
Histologically confirmed, positive HSIL of CIN+ or higher (only CIN+/ subjects will be selected) cervical biopsy, confirmed by external (independent) pathologist panel within the  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  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
Patients with untreated focal liver observations scheduled for follow-up multiphase contrast-enhanced CT or MRI, biopsy or surgical excision as part of clinical standard of care; CEUS should be performed within  weeks before or after follow-up imaging or within  weeks before biopsy or surgical excision
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  (New Diagnosis): \r\n** Pediatric patients with newly diagnosed primary central nervous system tumors undergoing surgical resection/biopsy within  days or who, within the prior  days, have undergone resection/biopsy with substantial residual (greater than half as assessed by the surgeon) tumor\r\n* Study  (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  days or from a prior resection/biopsy if no current biopsy material is available\r\n* Study  (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  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 > ,/ul\r\n* Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) =< . times the institutional upper limit of normal (ULN) within  days prior to biopsy
Patients who have biopsy confirmed multi-centric disease
Patients with peripheral lung lesions - 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
The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.
HER immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) ordered on core biopsy, if biopsy indicates invasive cancer; Oncotype DX or other deoxyribonucleic acid (DNA) testing performed on core biopsy or not requested
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
Patients with an extracoelomic solid tumor requiring SLN biopsy
Participants must be undergoing a surgical procedure with the intention of removing more tissue than what would be taken for a biopsy
Biopsy reviewed by a University of Miami pathologist
Requirement for medications, which interfere with platelet function, such as aspirin, which cannot be stopped within  week prior to the biopsy (applicable only to patients undergoing biopsy)
An interval of >  weeks between the biopsy and MRSI
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.
Participants who do not have residual calcifications present on mammogram following biopsy
No evidence on biopsy of extracapsular extension
PRE-ENROLLMENT BIOPSY PARAMETERS: minimum of  biopsy cores
FINAL ENROLLMENT BIOPSY PARAMETERS:  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  days prior to enrollment (patients with a biopsy of recurrent disease that is HER-positive and have not received HER-directed therapy since the biopsy can exceed the -day window up to  months); patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
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 LCCC) for research purposes only (approximately  mg or one core's worth of tissue needed)
Is willing to provide archival tumor tissue from a biopsy performed within  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  patients with adenocarcinoma will be offered an optional tumor biopsy (typically EGD biopsy) at  weeks; starting with adenocarcinoma patient #, patients must have an accessible tumor and must agree to tumor biopsy at  weeks; this will continue to be mandatory until a total of  patients have undergone biopsy at  weeks
Patients with peripheral lung lesions - 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
Have had stereotactic or ultrasound-guided biopsy with marker placement
Have measurable disease that is amenable to a radiographic or ultrasound-guided biopsy or may be biopsied in the office without radiologic guidance.
Sufficient fresh or frozen tissue remaining from pre-treatment core biopsy/incisional biopsy or willing to undergo biopsy for research purposes only (approximately mg or one cores worth of tissue needed)
Recently diagnosed (i.e., within  days of enrollment) with clinically suspicious or biopsy-proven early stage (i.e., stage I-II) NSCLC; the inclusion criteria will be operationalized as follows:\r\n* Recently diagnosed (i.e., within  days of definitive tissue biopsy) biopsy-proven NSCLC\r\n* Recently diagnosed (i.e., within  days of clinical diagnosis) probable NSCLC where \probable NSCLC\ is defined as a suspicious lung nodule for which the patient was referred for\r\n** Invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR\r\n** Surgical or radiation oncology consultation and \date of clinical diagnosis\ is defined as (whichever comes first)\r\n** Date of referral for invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR\r\n** Date of referral for surgical or radiation oncology consultation\r\n* Study sites should enroll patients that meet either of the above inclusion criteria as early as possible during the diagnostic work-up (i.e., if the patient meets the criteria for recently diagnosed, clinically suspicious NSCLC, definitive tissue biopsy is not required for eligibility)
The patient must have one negative cystoscopy  months following most recent biopsy
Lack of archive tumor tissue from a biopsy or surgical resection of a metastatic lesion done within  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  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 / inhibitor. Otherwise, the patient will be excluded from the study participation.
For Concomitant Treatment: Prior tumor resection or biopsy up to  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- monotherapy run-in treatment for  weeks followed by TAK- plus nivolumab combination treatment [ approximately / 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- monotherapy, after the  weeks of TAK- monotherapy, and after  weeks of TAK- 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- monotherapy run-in treatment for  weeks followed by TAK- plus nivolumab combination treatment (approximately/ 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- monotherapy, after the  weeks of TAK- monotherapy, and after  weeks of TAK- 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- monotherapy run-in treatment for  weeks followed by TAK- plus nivolumab combination treatment (approximately / 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- monotherapy, after the  weeks of TAK- monotherapy, and TAK- after  weeks of TAK- 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