An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers
- Interventional
- Recruiting
- NCT03956680
Contact Information
A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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
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
- 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
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