- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680416
Tissue Collection to ID TCRs From Renal Clear Cell Carcinoma Patients Responding to Immune Checkpoint Inhibitors
A Tissue Collection Study in Patients With Renal Clear Cell Carcinoma Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Known or suspected diagnosis of renal clear cell carcinoma.
- Age ≥18 years at time of diagnosis.
- ECOG performance status 0-2.
- Ability to understand and willingness to sign an informed consent document.
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.
- Patients undergoing an on-treatment biopsy must show a partial response of one or more lesions, as assessed by the investigator, using RECIST 1.1 or irRECIST criteria.
- Patients undergoing surgical resection of residual tumors must show a partial response by RECIST 1.1 or irRECIST criteria of at least one of the resected lesions.
- 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.
- Platelet count ≥50×109 /L prior to biopsy or per the service performing the biopsy.
- Absolute neutrophil count ≥1500×103 /L.
- Must be able to safely hold aspirin, clopidogrel (Plavix), prasugrel (Effient), cangrelor (Kengreal), or ticagrelor (Brilinta) for ≥5 days prior to biopsy.
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:
- No warfarin (Coumadin) for 5 days.
- No low-molecular weight heparin (LMWH; e.g. dalteparin/ Fragmin, enoxaparin/ Lovenox) for 24 hours.
- No fondaparinux/ Arixtra for 48 hours.
- 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:
- Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the subject's safety.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- History of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
- 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.
Active cardiac disease, defined as:
- Uncontrolled or symptomatic angina within the past 3 months.
- 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.
- Myocardial infarction < 6 months from study entry.
- Uncontrolled or symptomatic congestive heart failure.
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single Cell Sequencing
Time Frame: 1 year
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Number of patients, through single-cell sequencing, displaying the TCR repertoire of these tumor and blood samples with new targets
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Hsieh, MD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Neoplasms, Complex and Mixed
- Carcinoma, Renal Cell
- Carcinoma
- Adenocarcinoma, Clear Cell
- Adenomyoepithelioma
Other Study ID Numbers
- 202005006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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