An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
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| ClinicalTrials.gov Identifier: NCT03994601 |
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Recruitment Status :
Recruiting
First Posted : June 21, 2019
Last Update Posted : June 2, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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Brief Summary:
The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer | Drug: BMS-986288 Drug: Nivolumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 344 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors |
| Actual Study Start Date : | September 6, 2019 |
| Estimated Primary Completion Date : | September 15, 2023 |
| Estimated Study Completion Date : | April 13, 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A BMS-986288 |
Drug: BMS-986288
Specified dose on specified days |
| Experimental: Arm B BMS-986288 in combination with Nivolumab |
Drug: BMS-986288
Specified dose on specified days Drug: Nivolumab Specified dose on specified days
Other Names:
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Primary Outcome Measures :
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 2 years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years ]
- Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria [ Time Frame: Up to 2 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
- Incidence of AEs leading to death [ Time Frame: Up to 2 years ]
- Incidence of AEs leading to laboratory abnormalities [ Time Frame: Up to 2 years ]
Secondary Outcome Measures :
- Maximum Observed Concentration (Cmax) of BMS-986288 [ Time Frame: Up to 2 years ]
- Time of Maximum Observed Concentration (Tmax) of BMS-986288 [ Time Frame: Up to 2 years ]
- Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 [ Time Frame: Up to 2 years ]
- Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 [ Time Frame: Up to 2 years ]
- Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 [ Time Frame: Up to 2 years ]
- Trough Observed Concentrations (Ctrough) of BMS-986288 [ Time Frame: Up to 2 years ]
- Total Body Clearance (CLT) of BMS-986288 [ Time Frame: Up to 4 months ]
- Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 [ Time Frame: Up to 4 months ]
- Accumulation Index (AI) of BMS-986288 [ Time Frame: Up to 4 months ]
- Terminal Half-Life (T-HALF) of BMS-986288 [ Time Frame: Up to 4 months ]
- Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 [ Time Frame: Up to 2 years ]
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment [ Time Frame: Up to 4 years ]
- Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
- Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
- Time to Response (TTR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
- Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 2 years ]
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:
- Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
Exclusion Criteria:
- Active, known or suspected autoimmune disease
- Active malignancy requiring concurrent intervention
- Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
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): NCT03994601
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site #. |
Locations
Show 27 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: | NCT03994601 |
| Other Study ID Numbers: |
CA043-001 |
| First Posted: | June 21, 2019 Key Record Dates |
| Last Update Posted: | June 2, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |