To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.
Active, not recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Nivolumab | BMS-936558, MDX-1106 | Arm N - Nivolumab |
| Ipilimumab | Yervoy, BMS-734016, MDX-010 | Arm N-I, Level 1: Nivolumab+Ipilimumab |
| Cobimetinib | Cotellic | Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib |
All tumor types are now closed for enrollment:
Triple Negative Breast Cancer
Gastric Cancer
Pancreatic Cancer
Small Cell Lung Cancer
Bladder Cancer
Ovarian Cancer
| Name | Type | Description | Interventions |
|---|---|---|---|
| Arm N - Nivolumab | Experimental | Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Arm N-I, Level 1: Nivolumab+Ipilimumab | Experimental | Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Arm N-I, Level 2: Nivolumab+Ipilimumab | Experimental | Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Arm N-I, Level 2b: Nivolumab+Ipilimumab | Experimental | Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Arm N-I, Level 2c: Nivolumab+Ipilimumab | Experimental | Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib | Experimental | Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects with histologically or cytologically confirmed locally advanced or metastatic
disease of the following tumor types:
- Triple Negative Breast Cancer
- Gastric Cancer
- Pancreatic Cancer
- Small Cell Lung Cancer
- Bladder Cancer
- Ovarian Cancer
- Subjects must have measurable disease
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Adequate hematological and organ function as confirmed by laboratory values
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Subjects with active, known or suspected autoimmune disease
- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of treatment
- Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or
checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting
T cell is also prohibited
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Objective Response Rate ( ORR ) |
| Time Frame: | 60 months |
| Safety Issue: | |
| Description: | The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
August 11, 2020
