Trial record 3 of 4 for:
BMS-986218
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab 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: NCT03110107 |
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Recruitment Status :
Terminated
(Business Objectives have changed.)
First Posted : April 12, 2017
Last Update Posted : May 3, 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 determine whether BMS-986218 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: Ipilimumab Biological: BMS-986218 Biological: Nivolumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 512 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors |
| Actual Study Start Date : | May 4, 2017 |
| Actual Primary Completion Date : | April 4, 2024 |
| Actual Study Completion Date : | April 4, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part 1A: Monotherapy (BMS-986218) |
Biological: BMS-986218
Specified dose on specified days |
| Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab) |
Biological: BMS-986218
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Name: Opdivo |
| Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab) |
Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy Biological: BMS-986218 Specified dose on specified days |
| Experimental: Part 2B: Monotherapy (BMS-986218) |
Biological: BMS-986218
Specified dose on specified days |
| Experimental: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab) |
Biological: BMS-986218
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Name: Opdivo |
| Experimental: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab) |
Biological: BMS-986218
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Name: Opdivo |
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 toxicity (DLT) criteria [ Time Frame: Up to 2 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
- Incidence of death [ Time Frame: Up to 2 years ]
- Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]Parts 2A, 2B, 2C and 2D
- Median Duration of Response (mDOR) [ Time Frame: Up to 4 years ]Parts 2A, 2B, 2C and 2D
- Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 4 years ]Parts 2A, 2B, 2C and 2D
Secondary Outcome Measures :
- ORR [ Time Frame: Up to 4 years ]Parts 1A and 1B
- mDOR [ Time Frame: Up to 4 years ]Parts 1A and 1B
- PFSR by RECIST v1.1 [ Time Frame: Up to 4 years ]Parts 1A and 1B
- Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 4 years ]
- Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 4 years ]
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 4 years ]
- Trough observed serum concentration (Ctrough) [ Time Frame: Up to 4 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
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
- Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
- Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C)
- Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)
Exclusion Criteria:
- Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
- Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted
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): NCT03110107
Locations
Show 52 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: | NCT03110107 |
| Other Study ID Numbers: |
CA022-001 2017-000597-11 ( EudraCT Number ) |
| First Posted: | April 12, 2017 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | April 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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BMS-986218 Nivolumab Ipilimumab |
Additional relevant MeSH terms:
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Nivolumab Ipilimumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |