Trial record 1 of 1 for:
CA111-001
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05298592 |
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Recruitment Status :
Recruiting
First Posted : March 28, 2022
Last Update Posted : January 8, 2024
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer | Biological: BMS-986406 Biological: Nivolumab Drug: Carboplatin Drug: Pemetrexed Drug: Paclitaxel | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 154 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors |
| Actual Study Start Date : | March 31, 2022 |
| Estimated Primary Completion Date : | April 9, 2026 |
| Estimated Study Completion Date : | July 8, 2026 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part 1A: BMS-986406 (Monotherapy Dose Escalation) |
Biological: BMS-986406
Specified dose on specified days |
| Experimental: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation) |
Biological: BMS-986406
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion) |
Biological: BMS-986406
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) |
Biological: BMS-986406
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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| Experimental: Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel |
Biological: BMS-986406
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Drug: Carboplatin Specified dose on specified days Drug: Pemetrexed Specified dose on specified days Drug: Paclitaxel Specified dose on specified days |
Primary Outcome Measures :
- Number of participants with adverse events (AEs) [ Time Frame: Up to 100 days ]
- Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 100 days ]
- Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 28 days ]
- Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days ]
- Number of participants with death [ Time Frame: Up to 100 days ]
Secondary Outcome Measures :
- Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 14 days ]
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 14 days ]
- Trough observed plasma concentration (Ctrough) [ Time Frame: Up to 14 days ]
- Incidence of anti-drug antibody (ADAs) [ Time Frame: Up to 14 days ]
- Objective response rate (ORR) [ Time Frame: Up to 24 months ]
- Disease control rate (DCR) [ Time Frame: Up to 24 months ]
- Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma [ Time Frame: Up to 24 months ]
- DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer [ Time Frame: Up to 24 months ]
- DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types [ Time Frame: Up to 24 months ]
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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:
Parts 1A, 1B, 1C:
- Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
Part 1D:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.
All Parts:
- Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Prior organ or tissue allograft
- Leptomeningeal metastases
- Untreated CNS metastases
- Serious or uncontrolled medical disorders
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): NCT05298592
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT # and Site #. |
Locations
Show 34 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: | NCT05298592 |
| Other Study ID Numbers: |
CA111-001 2021-006872-17 ( EudraCT Number ) U1111-1270-3670 ( Registry Identifier: WHO ) |
| First Posted: | March 28, 2022 Key Record Dates |
| Last Update Posted: | January 8, 2024 |
| Last Verified: | January 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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Opdivo® Immunotherapy |
Additional relevant MeSH terms:
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Paclitaxel Carboplatin Nivolumab Pemetrexed 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 |