Advanced Solid Tumors Clinical Trial
Official title:
A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
| Verified date | March 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.
| Status | Active, not recruiting |
| Enrollment | 402 |
| Est. completion date | October 14, 2025 |
| Est. primary completion date | October 14, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant - Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS) - Participants must have experienced radiographically documented progressive disease on or after the most recent therapy Exclusion Criteria: - An active, known or suspected autoimmune disease - Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment - Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug - Untreated central nervous system (CNS) metastases or leptomeningeal metastasis Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 0007 | Edmonton | Alberta |
| Canada | Local Institution - 0011 | Hamilton | Ontario |
| Canada | Local Institution - 0005 | Ottawa | Ontario |
| Canada | Local Institution - 0006 | Toronto | Ontario |
| France | Local Institution - 0015 | Bordeaux | Aquitaine |
| France | Local Institution - 0018 | Marseille | |
| France | Local Institution - 0019 | Toulouse | |
| France | Local Institution - 0014 | Villejuif | Paris |
| Spain | Local Institution - 0022 | Madrid | |
| Spain | Local Institution - 0023 | Madrid | |
| Spain | Local Institution - 0025 | Madrid | Madrid, Comunidad De |
| Spain | Local Institution - 0024 | Málaga | Andalucía |
| Switzerland | Local Institution - 0012 | Basel | |
| Switzerland | Local Institution - 0020 | Genève | |
| Switzerland | Local Institution - 0021 | st.Gallen | Sankt Gallen |
| United States | Local Institution - 0010 | Boston | Massachusetts |
| United States | Local Institution - 0001 | Hackensack | New Jersey |
| United States | Local Institution - 0003 | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada, France, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Dose-Limiting Toxicities (DLTs) | Up to 28 days | ||
| Primary | Number of participants with Adverse Events (AEs) | Up to 29 months | ||
| Primary | Number of deaths | Up to 50 months | ||
| Secondary | Maximum concentration (Cmax) | Up to 27 months | ||
| Secondary | Time of maximum observed concentration (Tmax) | Up to 27 months | ||
| Secondary | Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T)) | Up to 27 months | ||
| Secondary | Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 50 months | ||
| Secondary | Duration of Response (DOR) assessed by RECIST v1.1 | Up to 50 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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