An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
- Conditions
- Advanced Cancer
- Interventions
- Biological: BMS-986258Biological: NivolumabDrug: rHuPH20
- Registration Number
- NCT03446040
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 92
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B Dose Escalation: BMS-986258 + nivolumab BMS-986258 - Part B Dose Escalation: BMS-986258 + nivolumab Nivolumab - Part C Cohort Expansion: BMS-986258 + nivolumab BMS-986258 - Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) BMS-986258 - Part A Dose Escalation: BMS-986258 BMS-986258 - Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) rHuPH20 - Part C Cohort Expansion: BMS-986258 + nivolumab Nivolumab -
- Primary Outcome Measures
Name Time Method Incidence of AEs leading to discontinuation Approximately 2 years Incidence of AEs leading to death Approximately 2 years Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria Approximately 2 years Incidence of serious adverse events (SAEs) Approximately 2 years Incidence of adverse events (AEs) Approximately 2 years
- Secondary Outcome Measures
Name Time Method Incidence of anti-drug antibody (ADA) to BMS-986258 Approximately 2 years Objective response rate (ORR) Up to 12 months Maximum observed serum concentration (Cmax) Approximately 2 years Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] Approximately 2 years Trough observed serum concentration at the end of the dosing interval (Ctrough) Approximately 2 years Median duration of response (mDOR) Up to 12 months Observed concentration at the end of a dosing interval (Ctau) Approximately 2 years Progression free survival (PFS) rate Up to 12 months Concentration at the end of infusion (Ceoi) Approximately 2 years Time of maximum observed concentration (Tmax) Approximately 2 years Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] Approximately 2 years
Trial Locations
- Locations (16)
Local Institution - 0012
🇺🇸Lebanon, New Hampshire, United States
Local Institution - 0007
🇺🇸Aurora, Colorado, United States
Local Institution - 0016
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0005
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0006
🇺🇸Los Angeles, California, United States
Local Institution - 0004
🇺🇸Los Angeles, California, United States
University Of Iowa Hospitals And Clinics
🇺🇸Iowa City, Iowa, United States
Local Institution - 0018
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0010
🇺🇸Grand Rapids, Michigan, United States
Local Institution - 0014
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0002
🇺🇸Germantown, Tennessee, United States
Local Institution - 0015
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0013
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0019
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0008
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0009
🇯🇵Kobe-shi, Hyogo, Japan