Advanced Cancer Clinical Trial
Official title:
A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
| Verified date | September 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.
| Status | Active, not recruiting |
| Enrollment | 255 |
| Est. completion date | November 10, 2026 |
| Est. primary completion date | April 22, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1 - Available tumor tissue for biomarker analysis - Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1 Exclusion Criteria: - Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease - History of interstitial lung disease / pneumonitis - Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer - Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0011 | Nedlands | Western Australia |
| Australia | Local Institution - 0012 | Wollstonecraft | New South Wales |
| France | Hopital De La Timone | Marseille Cedex 5 | |
| France | Institut Claudius Regaud | Toulouse Cedex 9 | |
| France | Institute Gustave Roussy | Villejuif | |
| Italy | Local Institution - 0010 | Forlì | |
| Italy | Local Institution - 0009 | Napoli | |
| Italy | Local Institution - 0023 | Rome | |
| Spain | Local Institution - 0019 | Barcelona | |
| Spain | Local Institution - 0018 | Madrid | |
| Spain | Local Institution - 0021 | Madrid | |
| Spain | Local Institution - 0022 | Málaga | |
| Spain | Local Institution - 0020 | Pamplona | |
| Switzerland | Local Institution - 0008 | Lausanne | |
| Switzerland | Local Institution - 0007 | Zuerich | |
| United Kingdom | Local Institution - 0013 | Headington | |
| United Kingdom | Local Institution - 0014 | Newcastle Upon Tyne | |
| United States | Local Institution - 0003 | Aurora | Colorado |
| United States | Local Institution - 0004 | Baltimore | Maryland |
| United States | Local Institution | Cleveland | Ohio |
| United States | Local Institution - 0006 | Duarte | California |
| United States | Local Institution - 0001 | Germantown | Tennessee |
| United States | Local Institution - 0005 | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, France, Italy, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of clinical laboratory test abnormalities | Approximately 4 years | ||
| Primary | Number of Adverse Events (AEs) | Approximately 4 years | ||
| Primary | Number of Serious Adverse Events (SAEs) | Approximately 4 years | ||
| Primary | Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to 6 weeks | ||
| Primary | Number of AEs leading to discontinuation | Approximately 4 years | ||
| Primary | Number of AEs leading to death | Approximately 4 years | ||
| Primary | Objective Response Rate (ORR) | Approximately 4 years | ||
| Primary | Disease Control Rate (DCR) | Approximately 4 years | ||
| Primary | Median Duration of Response (mDOR) | Approximately 4 years | ||
| Secondary | Progression-Free Survival (PFS) | Up to 4 years |
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