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.
Recruiting
Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| BMS-986301 | Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) | |
| Nivolumab | OPDIVO | Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) |
| Ipilimumab | YERVOY | Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) | Experimental |
| |
| Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study | Experimental |
| |
| Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study | Experimental |
| |
| Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab | Experimental |
| |
| Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab | Experimental |
|
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
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 could apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Incidence of dose-limiting toxicity (DLTs) |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: |
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
December 3, 2020
