NCT03101566

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

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]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Neoplasms

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 IV
DRUG	Cisplatin	Cisplatin 25 mg/m2 IV
DRUG	Ipilimumab	Ipilimumab 1 mg/kg IV
DRUG	Nivolumab	Nivolumab 360 mg or 240 mg IV

Timeline

• Start date: 2017-09-08
• Primary completion: 2019-12-03
• Completion: 2021-06-07
• First posted: 2017-04-05
• Last updated: 2022-10-28
• Results posted: 2021-08-10

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study