Description:
The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in
combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Title
- Brief Title: First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors
- Official Title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA022-001
- SECONDARY ID:
2017-000597-11
- NCT ID:
NCT03110107
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Ipilimumab | Yervoy | Part 2A: Monotherapy (BMS-986218 OR Ipilimumab) |
| BMS-986218 | | Part 1A: Monotherapy (BMS-986218) |
| Nivolumab | Opdivo | Part 1B: Combination Therapy (BMS-986218 + Nivolumab) |
Purpose
The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in
combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1A: Monotherapy (BMS-986218) | Experimental | | |
| Part 1B: Combination Therapy (BMS-986218 + Nivolumab) | Experimental | | |
| Part 2A: Monotherapy (BMS-986218 OR Ipilimumab) | Experimental | | |
| Part 2B: Monotherapy (BMS-986218) | Experimental | | |
Eligibility 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 Part 2B)
- Women must agree to follow methods of contraception, if applicable
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 could apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incidence of Adverse Events (AEs) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | ORR of BMS-986218 alone or in combination with Nivolumab |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | mDOR of BMS-986218 alone or in combination with Nivolumab |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | PFS of BMS-986218 alone or in combination with Nivolumab |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-drug antibody (ADA) to BMS-986218 |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed serum concentration (Cmax) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed concentration (Tmax) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the concentration-time curve from time zero to the time of the |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Trough observed serum concentration (Ctrough) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Total body clearance (CLT) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Terminal serum half-life if data permit (T-HALF) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Observed concentration at the end of a dosing interval (Ctau) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
July 12, 2021
