Phase
Condition
Neoplasms
Treatment
Tumor Biopsy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo,Cohort 5: Post-Treatment Responder (Frozen)
- Study Cohorts 1,2,3 and 5: Known or suspected diagnosis of non-hematologicalmalignancy.
- Age 18 years at time of diagnosis.
- Research Biopsy Study Cohorts 1 and 2: ECOG performance status 0-2.
- Ability to understand and willingness to sign an informed consent document.
- Research Biopsy Study Cohorts 1,2,3 and 5: Patients must be eligible for or currentlyreceiving treatment with immune checkpoint inhibitor (ICI) therapy as determined bythe patient's treating oncologist. The treatment regimen may comprise more than oneagent but must include at least one ICI drug. Examples of FDA-approved ICI drugsinclude pembrolizumab (Keytruda), nivolumab (Opdivo), atezolizumab (Tecentriq),avelumab (Bavencio), durvalumab (Imfinzi), cemiplimab (Libtayo), and ipilimumab (Yervoy). Immune-checkpoint inhibitors not on this list may also be used, providedthey are FDA-approved.
- Research Biopsy Study Cohorts 1,2,3 and 5: Patients undergoing an on-treatment biopsymust show radiographic regression of one or more lesion, as assessed by theinvestigator.
- Research Biopsy Study Cohorts 1 and 2: Patients undergoing an on-treatment biopsy musthave a cancer lesion that is amenable for biopsy under local anesthesia or moderatesedation per standard procedures. The tumor biopsy must have an acceptable clinicalrisk, as judged by the investigator.
- Research Biopsy Study Cohorts 1,2,4: Platelet count >50,000 prior to biopsy or per theservice performing the biopsy.
- Research Biopsy Study Cohorts 1,2,4: Absolute neutrophil count >1500.
- Research Biopsy Study Cohorts 1,2,4: Must be able to safely hold anticoagulants for 5days prior to biopsy.
- Research Biopsy Study Cohorts 1,2,4: Not receiving therapeutic anticoagulation at thetime of the biopsy. Patients on therapeutic anticoagulation must be able to safelyhold anticoagulation for the procedure with an acceptable risk, as judged by theinvestigator. Patients who are on anticoagulation for clinical reasons and deemedappropriate for biopsy must be OFF anticoagulation prior to biopsy as follows: i. No warfarin (Coumadin) for 5 days. No low-molecular weight heparin (LMWH; e.g.dalteparin/ Fragmin, enoxaparin/ Lovenox) for 24 hours. ii. No fondaparinux/ Arixtra for 48 hours. iii. Patients receiving alternative forms ofanticoagulation not listed above (e.g., dabigatran, rivaroxaban, apixaban, edoxaban) shouldconsult with the prescribing physician and the service performing the biopsy regardingsafety and administration guidelines prior to biopsy. Bleeding risks with these agentsshould be considered when deciding on whether to perform the biopsy if for researchpurposes only.
Exclusion
Exclusion Criteria: Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo,Cohort 5: Post-Treatment Responder (Frozen)
- Concurrent disease or condition that would make the patient inappropriate for studyparticipation, or any serious medical or psychiatric disorder that would interferewith safety.
- Dementia, altered mental status, or any psychiatric condition that would prohibit theunderstanding or rendering of informed consent.
- Research Biopsy Study Cohorts 1,2,4: History of serious or life-threatening allergicreaction to local anesthetics (i.e., lidocaine, xylocaine).
- Pregnant women are excluded because there may be an increased risk to both mother andfetus in the setting of moderate sedation, which is required for biopsies of certainanatomic sites (e.g., liver, lung, bone). Also, ionizing radiation from CT-guidedbiopsies may pose a risk to the unborn fetus.
- Research Biopsy Study Cohorts 1,2,4: Active cardiac disease, defined as: i. Uncontrolled or symptomatic angina within the past 3 months. ii. History of clinicallysignificant arrhythmias (such as ventricular tachycardia, ventricular fibrillation,torsades de pointes). Atrial fibrillation with controlled ventricular response on treatmentis not an exclusion. iii. Myocardial infarction < 6 months from study entry. iv. Uncontrolled or symptomaticcongestive heart failure. f. Any other condition, which in the opinion of the patient'streating oncologist or the physician performing the biopsy procedure, would makeparticipation in this protocol unreasonably hazardous for the patient.
Study Design
Connect with a study center
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesActive - Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana 70124
United StatesActive - Recruiting
Atlantic Health System
Morristown, New Jersey 07960
United StatesActive - Recruiting
Advanced Oncology PC
New York, New York 10013
United StatesActive - Recruiting
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