A 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

Study Name
A 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
ClinicalTrials.gov Identifier (if applicable)
Study Center
Institution Name
University of Michigan
Institution Address
1500 E Medical Center Dr
Ann Arbor
Zip Code
(734) 936-4991
Study Contacts
Principal Investigator
Vaibhav Sahai, MD
P.I. Phone
(734) 936-4991
P.I. Email
Study Coordinator
Courtney Wolf
Study Coordinator Phone
(734) 936-4786
Study Coordinator Email
OVERVIEW – in layman’s terms (150 words max)
The study is investigating the role of immunotherapy in combination with chemotherapy or dual immunotherapy as first line therapy for unresectable or metastatic patients with biliary tract cancer.
Study Start Date
Estimated Completion Date
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The goal of this clinical trial is to improve survival for patients with biliary tract cancer by using immunotherapy.
Inclusion Criteria – Patients Must:
  • 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.
  • 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.
  • 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.
  • Age≥18 years
  • Child-Pugh score of A (prognosis in chronic liver disease and cirrhosis)
  • 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
  • Adequate organ function obtained ≤ 2 weeks prior to registration
Exclusion Criteria – Patients Must NOT:
  • 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 receiving systemic steroid therapy, or any other form of immunosuppressive therapy within 7 days prior to trial treatment.
  • No known Hepatitis B, Hepatitis C, or HIV seropositivity. Testing is not required in absence of clinical suspicion.
  • No 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 nab-paclitaxel and/or gemcitabine 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. 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 14 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.
  • Imaging of the chest, abdomen and pelvis
  • Blood tests
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Chemotherapy and immunotherapy side effects will be explained in detail during the meeting with the study staff and investigators. Briefly, the immunotherapy allows the immune system to attack the cancer cells but sometimes it can attack the normal tissue in our body which can lead to side effects.
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