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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03101566
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 IV
  • Cisplatin — DRUG
    Cisplatin 25 mg/m2 IV
  • Ipilimumab — DRUG
    Ipilimumab 1 mg/kg IV
  • Nivolumab — DRUG
    Nivolumab 360 mg or 240 mg IV

Study Details

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.

Key Dates

Start date
Sep 8, 2017
Status verified
Sep 2022
Primary completion
Dec 3, 2019
Completion
Jun 7, 2021

Study Design

Enrollment
75 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + Cisplatin + Nivolumab
    Drug: Gemcitabine 1000 mg/m2 IV on days 1,8 every 3 weeks Drug: Cisplatin 25 mg/m2 IV on days 1,8 every 3 weeks Drug: Nivolumab 360 mg IV on day 1 every 3 weeks If there is continued benefit after 6 months, then: Drug: Nivolumab 240 mg IV on day 1 every 2 weeks
  • Experimental: Nivolumab + Ipilimumab
    Drug: Ipilimumab 1 mg/kg IV on day 1 every 6 weeks Drug: Nivolumab 240 mg IV on day 1 every 2 weeks

Primary Outcome Measure

The Percentage of Patients Alive and Without Progression at 6 Months Following the Initiation of Treatment [ Time Frame: 6 Months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of WashingtonSeattleWashington98109-
University of WisconsinMadisonWisconsin53705-

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GANorthwestern University· Chicago, ILUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIUniversity of Pennsylvania· Philadelphia, PAUniversity of Texas Southwestern Medical Center· Dallas, TXUniversity of Washington· Seattle, WA

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