Clinical Trial: Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Multi-Center Randomized Phase II Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer [CA209-

Brief Summary:

The purpose of this trial is to evaluate the effect of investigational drug nivolumab in combination with either gemcitabine/cisplatin chemotherapy, or in combination with another investigational agent ipilimumab in patients with advanced unresectable biliary tract cancer.

Gemcitabine/cisplatin is the standard of care treatment for biliary tract cancer.

Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab (Opdivo) is FDA approved for the treatment of several cancers including metastatic melanoma, advanced lung, kidney, head & neck and bladder cancer. The combination of nivolumab and ipilimumab (Yervoy) is FDA approved for metastatic melanoma.


Detailed Summary:
Sponsor: University of Michigan Cancer Center

Current Primary Outcome: The percentage of patients alive and without progression at 6 months following the initiation of treatment [ Time Frame: 6 Months ]

The primary endpoint is PFS (Progression Free Survival) at 6 months following the initiation of treatment. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (irRECIST) definition.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The percentage of patients that respond to treatment [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest ]
    Overall response rate is defined as the sum of partial responses and complete responses. Partial and complete response will be defined as per irRECIST criteria.
  • Median progression free survival time [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest ]
    The median time patients are alive without progression following the initiation of treatment wherein progression will be defined clinically or on imaging as per irRECIST criteria.
  • Median overall survival time [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest ]
    The median overall survival time following the initiation of treatment.


Original Secondary Outcome: Same as current

Information By: University of Michigan Cancer Center

Dates:
Date Received: March 30, 2017
Date Started: May 1, 2017
Date Completion: November 1, 2020
Last Updated: May 24, 2017
Last Verified: May 2017