A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01928394 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

To investigate the safety and efficacy of Nivolumab as a single agent or in combination with Ipilimumab in 4 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC) and Bladder Cancer (BC).

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Patrick Ott, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types: - Triple Negative Breast Cancer - Gastric Cancer - Pancreatic Cancer - Small Cell Lung Cancer - Subjects must have measurable disease - Eastern Cooperative Oncology Group (ECOG) of 0 or 1 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
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