Description:
The purpose of this study is to determine whether BMS-986258 both monotherapy and in
combination with Nivolumab is safe and tolerable in the treatment of advanced malignant
tumors.
Title
- Brief Title: An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
- Official Title: A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA031-002
- SECONDARY ID:
2019-000442-35
- NCT ID:
NCT03446040
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986258 | | Part A Dose Escalation: BMS-986258 |
| Nivolumab | Opdivo, BMS-936558 | Part B Dose Escalation: BMS-986258 + nivolumab |
| rHuPH20 | Enhanze | Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) |
Purpose
The purpose of this study is to determine whether BMS-986258 both monotherapy and in
combination with Nivolumab is safe and tolerable in the treatment of advanced malignant
tumors.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part A Dose Escalation: BMS-986258 | Experimental | | |
| Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) | Experimental | | |
| Part B Dose Escalation: BMS-986258 + nivolumab | Experimental | | |
| Part C Cohort Expansion: BMS-986258 + nivolumab | Experimental | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal
cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head
and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or
unresectable), with measurable disease per response evaluation criteria in solid
tumors v1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Participants 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 solid tumor histologies
- Women must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- Active, known or suspected autoimmune disease
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior
anti-cancer therapy and initiation of study therapy
- Other active malignancy requiring concurrent intervention
Other protocol-defined inclusion/exclusion criteria 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: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Objective response rate (ORR) |
| Time Frame: | up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Median duration of response (mDOR) |
| Time Frame: | up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Progression free survival (PFS) rate |
| Time Frame: | up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed serum concentration (Cmax) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed concentration (Tmax) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Observed concentration at the end of a dosing interval (Ctau) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Trough observed serum concentration at the end of the dosing interval (Ctrough) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Concentration at the end of infusion (Ceoi) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-drug antibody (ADA) to BMS-986258 |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
May 12, 2021
