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