Phase 2
Completed N=1,131
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov NCT01928394 ↗
Enrolled (actual)
1,131
Serious AEs
61.8%
Results posted
Mar 2020
Primary outcomePrimary: Objective Response Rate ( ORR ) — 5.6; 0.0; 0.0; 11.9 Percentage of Participants — p=0.0309
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate ( ORR ) |
5.6; 0.0; 0.0; 11.9; 0.0; 24.5 | 0.0309 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01928394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.