Trial record 1 of 1 for:
CA099-003
A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05407675 |
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Recruitment Status :
Active, not recruiting
First Posted : June 7, 2022
Last Update Posted : March 15, 2024
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumors | Drug: BMS-986408 Biological: Nivolumab Biological: Ipilimumab Biological: Platinum-doublet chemotherapy Drug: Rabeprazole | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 402 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | August 2, 2022 |
| Estimated Primary Completion Date : | October 14, 2025 |
| Estimated Study Completion Date : | October 14, 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part 1: BMS-986408 Monotherapy |
Drug: BMS-986408
Specified dose on specified days |
| Experimental: Part 2: BMS-986408 in combination with nivolumab |
Drug: BMS-986408
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab |
Drug: BMS-986408
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
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| Experimental: Part 2: BMS-986408 in combination with nivolumab and chemotherapy |
Drug: BMS-986408
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Biological: Platinum-doublet chemotherapy Specified dose on specified days
Other Names:
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| Experimental: Part 2: BMS-986408 in combination with rabeprazole |
Drug: BMS-986408
Specified dose on specified days Drug: Rabeprazole Specified dose on specified days |
| Experimental: Part 3: BMS-986408 in combination with nivolumab |
Drug: BMS-986408
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 3: BMS-986408 in combination with nivolumab and chemotherapy |
Drug: BMS-986408
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Biological: Platinum-doublet chemotherapy Specified dose on specified days
Other Names:
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Primary Outcome Measures :
- Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to 29 months ]
- Number of deaths [ Time Frame: Up to 50 months ]
Secondary Outcome Measures :
- Maximum concentration (Cmax) [ Time Frame: Up to 27 months ]
- Time of maximum observed concentration (Tmax) [ Time Frame: Up to 27 months ]
- Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T)) [ Time Frame: Up to 27 months ]
- Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 50 months ]
- Duration of Response (DOR) assessed by RECIST v1.1 [ Time Frame: Up to 50 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407675
Locations
Show 18 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT05407675 |
| Other Study ID Numbers: |
CA099-003 |
| First Posted: | June 7, 2022 Key Record Dates |
| Last Update Posted: | March 15, 2024 |
| Last Verified: | March 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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Cancer Oncology Phase 1 Solid Tumor |
Additional relevant MeSH terms:
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Neoplasms Paclitaxel Cisplatin Nivolumab Pemetrexed Ipilimumab Rabeprazole Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |