An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers
Phase 1
Completed
- Conditions
- Advanced Solid Cancers
- Interventions
- Drug: BMS-986301Biological: NivolumabBiological: Ipilimumab
- Registration Number
- NCT03956680
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- Must have experienced radiographically documented progressive disease on or after the most recent therapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Read More
Exclusion Criteria
- Primary central nervous system (CNS) malignancy
- Other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria apply
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) BMS-986301 - Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) Nivolumab - Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) Ipilimumab - Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study Ipilimumab - Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study BMS-986301 - Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study Nivolumab - Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab BMS-986301 - Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study BMS-986301 - Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study Nivolumab - Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study Ipilimumab - Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab Nivolumab - Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab Ipilimumab - Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab BMS-986301 - Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab Nivolumab - Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab Ipilimumab -
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events (SAEs) From Baseline until study exit (up to approximately 2 years) Incidence of deaths From Baseline until study exit (up to approximately 2 years) Incidence of clinically significant changes in clinical laboratory results: Hematology tests From Baseline until disease progression (approximately 2 years) Incidence of dose-limiting toxicity (DLTs) Cycle 1 (28 days) Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests From Baseline until disease progression (approximately 2 years) Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests From Baseline until disease progression (approximately 2 years) Incidence of adverse events (AEs) From Baseline until study exit (up to approximately 2 years) Incidence of AEs leading to discontinuation From Baseline until study exit (up to approximately 2 years)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Local Institution - 0003
🇺🇸Chicago, Illinois, United States
Local Institution - 0002
🇺🇸Nashville, Tennessee, United States
Local Institution - 0005
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0006
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0001
🇨🇦Toronto, Ontario, Canada