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NCT07848295
A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)
Conditions: Clear Cell Renal Cell Carcinoma (ccRCC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 112
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Location: Local Institution - 0018 New Haven Connecticut
Summary
The purpose of this study is to assess the safety and tolerability of BMS-986527 in participants with Clear Cell Renal Cell Carcinoma (ccRCC)
Eligibility Criteria
Inclusion Criteria
* Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic renal cell carcinoma (RCC) with clear cell component.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participants must have measurable disease as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
* For Cohorts 1 and 2, participants should have previously received, be refractory to, ineligible for, or intolerant of standard of care (SoC) immunotherapy (IO) and/or tyrosine kinase inhibitors (TKIs). Participants in Cohort 3 should have previously received, be refractory to, ineligible for, or intolerant of SoC IO, but those who have not been previously exposed to SoC TKI agents are permitted.
Exclusion Criteria
* Participants must not have prior history of malignancies (other than clear cell renal cell carcinoma (ccRCC)) or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years.
* For Cohort 2 only: has relapsed or is refractory within 12 months of the most recent IO therapy.
* For Cohort 3 only: use of strong inhibitor and inducers of CYP3A4, and P-glycoprotein (P-gp) substrates within 14 days or 5 half-lives (whichever is longer) of start of TKI.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Source: ClinicalTrials.gov (NCT07848295). StuddyBuddy aggregates publicly available trial information.