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Relatlimab + Nivolumab Fixed Dose Combination (FDC)

DRUG3 trials

Sponsors

Bristol Myers Squibb International Corporation, Exelixis Inc., Bristol-Myers Squibb Services Unlimited Company

Conditions

Clear cell renal cell carcinoma (ccRCCMetastatic Colorectal CancerNon-squamous (NSQ)Stage IV or Recurrent Non-small Cell Lung Cancerfirst-first-line) cell carcinoma - Colorectal cancer (CRC) - Hepatocellular cancer (HCC) - Non-small cell lung caner (NSCLC) - Head and Neck Squamous Cell Carcinoma (HNSCC)second- and third-line) - metastatic castration-resistant prostate cancer (mCRPCsecond-line post NHT) - urothelial carcinoma (UC) ICI naïve and ICI-experienced - non-clear cell renal (nccRCC

Phase 1

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors
Active, not recruitingCTIS2023-510061-10-00
Exelixis Inc.Clear cell renal cell carcinoma (ccRCC, first-, first-line) cell carcinoma - Colorectal cancer (CRC) - Hepatocellular cancer (HCC) - Non-small cell lung caner (NSCLC) - Head and Neck Squamous Cell Carcinoma (HNSCC) +2
Start: 2023-01-09Target: 407Updated: 2025-11-06

Phase 3

A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixeddose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal Cancer
CompletedCTIS2023-503797-21-00
Bristol Myers Squibb International CorporationMetastatic Colorectal Cancer
Start: 2022-08-10End: 2025-07-14Target: 233Updated: 2025-06-26
A Phase 3, Randomized, open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 expression ≥1%
RecruitingCTIS2024-513682-40-01
Bristol-Myers Squibb Services Unlimited CompanyNon-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer
Start: 2025-07-04Target: 288Updated: 2025-10-08