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Clinical Trial VICCGI13104

Title

A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer

Principal Investigator(s)

Emily Chan

Details

  • Protocol No. VICCGI13104
  • Open Date: 08/06/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To evaluate the investigator objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with metastatic MSI-H CRC.
  • Disease Sites: Colon
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Ipilimumab; Nivolumab (BMS-936558)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02060188
  • Secondary Protocol No: CA209142

Description

Patients are being asked to take part in this research study because they have colon cancer. The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) either as a single agent therapy or when combined with a drug called ipilimumab. This study will specifically test the safety and effectiveness of the investigational drug in patients whose tumors contain a certain genetic marker called microsatellite instability.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
• Men and women ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Histologically confirmed colorectal cancer
• Measurable disease by CT or MRI
• Testing for MSI Status
• Adequate organ function as defined by study-specific laboratory tests
• Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP
• Signed informed consent
• Willing and able to comply with study procedures
Exclusion Criteria:
• Active brain metastases or leptomeningeal metastases are not allowed.
• Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Prior malignancy active within the previous 3 years except for locally curable cancers
• Subjects with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration