Clinical Trials in France / NCT07848295
Starting soon
Phase 1
A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)
NCT07848295 · tracked via the Priya Life Science France tracker
Condition(s) studied
Clear Cell Renal Cell Carcinoma (ccRCC)
Investigational drug(s) / intervention(s)
BMS-986527: Specified dose on specified days
Nivolumab: Specified dose on specified days
Cabozantinib: Specified dose on specified days
Study 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
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.
Primary outcome measure(s)
- Incidence of adverse events (AEs) — Up to 2 years
- Incidence of serious adverse events (SAEs) — Up to 2 years
- Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria — Up to 2 years
- Incidence of AEs leading to discontinuation — Up to 2 years
- Number of deaths — Up to 2 years
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0018 | New Haven | Connecticut | |
| Local Institution - 0022 | Basking Ridge | New Jersey | |
| Local Institution - 0024 | New York | New York | |
| Local Institution - 0017 | Cleveland | Ohio | |
| Local Institution - 0019 | Houston | Texas | |
| Local Institution - 0026 | Seattle | Washington | |
| Local Institution - 0004 | Ghent | Oost-Vlaanderen | |
| Local Institution - 0003 | Leuven | Belgium | |
| Local Institution - 0007 | Villejuif | Val-de-Marne | |
| Local Institution - 0014 | Marseille | France | |
| Local Institution - 0005 | Essen | North Rhine-Westphalia | |
| Local Institution - 0012 | Jena | Thuringia | |
| Local Institution - 0010 | Rozzano | Milano | |
| Local Institution - 0011 | Roma | Italy | |
| Local Institution - 0008 | Amsterdam | Netherlands | |
| Local Institution - 0020 | Madrid | Spain | |
| Local Institution - 0002 | Madrid | Spain |
More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07848295 on ClinicalTrials.gov ↗ ← All trials in France