At a glance
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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 [CA209-9FC]
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, Cisplatin, and 2 other interventions for Biliary Tract Neoplasms. Completed, enrolled 75 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
Gemcitabine 1000 mg/m2 IV
Cisplatin 25 mg/m2 IV
Ipilimumab 1 mg/kg IV
Nivolumab 360 mg or 240 mg IV