Trial record 1 of 1 for:
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
|
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: NCT03369223 |
|
Recruitment Status :
Active, not recruiting
First Posted : December 11, 2017
Last Update Posted : May 16, 2023
|
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer | Biological: BMS-986249 Biological: Nivolumab Biological: Ipilimumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 425 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors |
| Actual Study Start Date : | December 6, 2017 |
| Estimated Primary Completion Date : | September 19, 2024 |
| Estimated Study Completion Date : | September 19, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part 1A: BMS-986249 |
Biological: BMS-986249
Specified dose on specified days |
| Experimental: Part 1B: BMS-986249 + nivolumab (nivo) |
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
|
Experimental: Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
|
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
|
Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
|
Experimental: Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
|
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
|
Experimental: Part 2B Cohort 1: BMS-986249 + nivo
Advanced or intermediate hepatocellular carcinoma (HCC)
|
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
|
Experimental: Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
|
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
|
Experimental: Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
|
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
|
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A Arm B: BMS-986249 + nivo
|
Biological: BMS-986249
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A Arm E: Nivo
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
|
Primary Outcome Measures :
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 2.5 years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2.5 years ]
- Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 2.5 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 2.5 years ]
- Incidence of death [ Time Frame: Up to 4 years ]
- Number of participants with laboratory abnormalities [ Time Frame: Up to 2.5 years ]
- Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
- Objective Response Rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2.5 years ]
Secondary Outcome Measures :
- Cmax (Maximum observed serum concentration) [ Time Frame: Up to 2 years ]
- Tmax (Time of maximum observed concentration) [ Time Frame: Up to 2 years ]
- AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) [ Time Frame: Up to 2 years ]
- ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer) [ Time Frame: Up to 4 years ]
- Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
- Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
- Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
- Incidence of AEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
- Incidence of SAEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
- Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
- Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
- Number of participants with clinical laboratory abnormalities Part 2 of study [ Time Frame: Up to 2.5 years ]
- Time to Deterioration (TTD) in Part 2 of study [ Time Frame: Up to 4 Years ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
- Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
- Willing and able to comply with all study procedures
Exclusion Criteria:
- Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
- Other active malignancy requiring concurrent intervention
- Prior organ allograft
- Active, known, or suspected autoimmune disease
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): NCT03369223
Locations
Show 44 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: | NCT03369223 |
| Other Study ID Numbers: |
CA030-001 2018-000416-21 ( EudraCT Number ) |
| First Posted: | December 11, 2017 Key Record Dates |
| Last Update Posted: | May 16, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
|
Antibodies Antineoplastic Agents Immunologic Factors |
Nivolumab Antibodies, Monoclonal Physiological Effects of Drugs |
Additional relevant MeSH terms:
|
Nivolumab Ipilimumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |