A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.
NCT ID: NCT05230186
Last Updated: 2022-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-02-26
2024-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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On-Treatment Solid Tumor Responder (Tumor Biopsy)
Research tumor tissue biopsy collected at any one time point while responding to ICI therapy (radiographic regression of lesion). Tumor biopsy and companion blood sample.
Tumor Biopsy
Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
Pre and On-Treatment Solid Tumor Responder (Tumor Biopsy)
Tumor tissue collection prior to beginning ICI therapy (optional biopsy). If and when there is a response to ICI therapy, a second research tumor tissue biopsy is collected. Tumor biopsy and companion blood sample.
Tumor Biopsy
Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
On-Treatment Solid Tumor Responder (Surgical Removal Tumor)
Collection of excess tumor tissue in patients who are responding to ICI therapy and are scheduled for Surgical resection of residual disease. Excess tissue provided.
No interventions assigned to this group
Post-Treatment of patients with Melanoma who develop vitiligo
Up to 5 patients treated for melanoma that develop vitiligo - Skin Tissue Biopsy obtained at any point in time from any skin site with vitiligo (selected sites only). Tissue biopsy
Tumor Biopsy
Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
On-Treatment Responder (Previously Frozen Tumor Tissue)
Previously Cryopreserved Tissue obtained from a Biobank or Tissue Repository, collected from patients when they were responding to ICI Therapy (clinical data required).
No interventions assigned to this group
Interventions
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Tumor Biopsy
Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Study Cohorts 1,2,3 and 5: Known or suspected diagnosis of non-hematological malignancy.
2. Age 18 years at time of diagnosis.
3. Research Biopsy Study Cohorts 1 and 2: ECOG performance status 0-2.
4. Ability to understand and willingness to sign an informed consent document.
5. Research Biopsy Study Cohorts 1,2,3 and 5: Patients must be eligible for or currently receiving treatment with immune checkpoint inhibitor (ICI) therapy as determined by the patient's treating oncologist. The treatment regimen may comprise more than one agent but must include at least one ICI drug. Examples of FDA-approved ICI drugs include 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, provided they are FDA-approved.
6. Research Biopsy Study Cohorts 1,2,3 and 5: Patients undergoing an on-treatment biopsy must show radiographic regression of one or more lesion, as assessed by the investigator.
7. Research Biopsy Study Cohorts 1 and 2: Patients undergoing an on-treatment biopsy must have a cancer lesion that is amenable for biopsy under local anesthesia or moderate sedation per standard procedures. The tumor biopsy must have an acceptable clinical risk, as judged by the investigator.
8. Research Biopsy Study Cohorts 1,2,4: Platelet count \>50,000 prior to biopsy or per the service performing the biopsy.
9. Research Biopsy Study Cohorts 1,2,4: Absolute neutrophil count \>1500.
10. Research Biopsy Study Cohorts 1,2,4: Must be able to safely hold anticoagulants for 5 days prior to biopsy.
11. Research Biopsy Study Cohorts 1,2,4: Not receiving therapeutic anticoagulation at the time of the biopsy. Patients on therapeutic anticoagulation must be able to safely hold anticoagulation for the procedure with an acceptable risk, as judged by the investigator. Patients who are on anticoagulation for clinical reasons and deemed appropriate 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 of anticoagulation not listed above (e.g., dabigatran, rivaroxaban, apixaban, edoxaban) should consult with the prescribing physician and the service performing the biopsy regarding safety and administration guidelines prior to biopsy. Bleeding risks with these agents should be considered when deciding on whether to perform the biopsy if for research purposes only.
Exclusion Criteria
1. Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with safety.
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
3. Research Biopsy Study Cohorts 1,2,4: History of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
4. Pregnant women are excluded because there may be an increased risk to both mother and fetus in the setting of moderate sedation, which is required for biopsies of certain anatomic sites (e.g., liver, lung, bone). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus.
5. 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 clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.
iii. Myocardial infarction \< 6 months from study entry. iv. Uncontrolled or symptomatic congestive heart failure. f. Any other condition, which in the opinion of the patient's treating oncologist or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
18 Years
ALL
No
Sponsors
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TScan Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Atlantic Health System
Morristown, New Jersey, United States
Advanced Oncology PC
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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200-04
Identifier Type: -
Identifier Source: org_study_id
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