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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:September 8, 2017
End Date:November 1, 2020
Contact:Vaibhav Sahai, MBBS, MS
Email:CTSU-Oncology-Multisite@med.umich.edu
Phone:734-936-4991

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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]

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.


Inclusion Criteria:

- Patients must have a pathologically confirmed adenocarcinoma of the biliary tract
(intra-hepatic, extra-hepatic (hilar, distal) or gall bladder) that is not eligible
for curative resection, transplantation, or ablative therapies. Tumors of mixed
histology are excluded.

- Patients may have received prior radiation, chemoembolization, radioembolization or
other local ablative therapies or hepatic resection if completed ≥ 4 weeks prior to
registration AND if patient has recovered to <= grade 1 toxicity. Extrahepatic
palliative radiation is permitted if completed ≥ 2 weeks prior to enrollment AND if
patient has recovered to ≤ grade 1 toxicity.

- Patients must have radiographically measurable disease in at least one site not
previously treated with radiation or liver directed therapy (including bland, chemo-
or radio-embolization, or ablation) either within the liver or in a metastatic site.

- Must be ≥18 years of age

- Must have a Child-Pugh score of A (prognosis in chronic liver disease and cirrhosis)

- Must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

- Ability to understand and willingness to sign IRB-approved informed consent

- Willing to provide archived tissue, if available, from a previous diagnostic biopsy

- Must be able to tolerate CT (computerized tomography) and/or MRI (magnetic resonance
imaging) with contrast

- Must have adequate organ function obtained ≤ 2 weeks prior to registration

Exclusion Criteria:

- Patients may not have received prior systemic treatment (chemotherapy or targeted
therapy) for advanced BTC (biliary tract cancer). Prior adjuvant chemotherapy is
permitted provided it was completed > 6 months from registration.

- Must not have a diagnosis of immunodeficiency, or have received systemic steroid
therapy, or any other form of immunosuppressive therapy within 7 days prior to trial
treatment.

- Must not have known Hepatitis B, Hepatitis C, or HIV seropositivity. Testing is not
required in absence of clinical suspicion.

- Must not have prior history of organ transplantation or brain metastasis.

- Must not have undergone a major surgical procedure < 4 weeks prior to registration.

- Must not have an active second malignancy other than non-melanoma skin cancer or
cervical carcinoma in situ. Patients with history of malignancy are eligible provided
primary treatment of that cancer was completed > 1 year prior to registration and the
patient is free of clinical or radiologic evidence of recurrent or progressive
malignancy.

- Must have no ongoing active, uncontrolled infections

- Must not have received a live vaccine within 30 days of planned start of the study
therapy.

- Must not have a psychiatric illness, other significant medical illness, or social
situation which, in the investigator's opinion, would limit compliance or ability to
comply with study requirements.

- Women must not be pregnant or breastfeeding since study drugs may harm the fetus or
child.

- Women of child-bearing potential and men must agree to use 2 methods of adequate
contraception (hormonal plus barrier or 2 barrier forms) OR abstinence prior to study
entry, for the duration of study participation and for 5 months (for women) and 7
months (for men) following completion of study therapy.

- Participants with an active, known or suspected autoimmune disease which may affect
vital organ function, or has/may require systemic immunosuppressive therapy for
management are excluded. Participants with type I diabetes mellitus, hypothyroidism
only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or
alopecia) not requiring systemic treatment, or conditions not expected to recur in the
absence of an external trigger are permitted to enroll.

- Participants with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalent) or other immunosuppressive medications within 7
days of start of study treatment. Inhaled or topical steroids, and adrenal replacement
steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of
active autoimmune disease.
We found this trial at
7
sites
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Al B. Benson, III, MD
Phone: 312-695-0990
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Walid Shaib, MD
Phone: 404-778-1900
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: David Zehn, MD
Phone: 206-606-1743
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Vaibhav Sahai, MBBS, MS
Phone: 734-936-4991
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Muhammad Beg, MD
Phone: 214-645-4673
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Dustin Deming, MD
Phone: 608-265-1700
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Jennifer Eads, MD
Phone: 215-360-0716
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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