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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03101566
Recruitment Status : Active, not recruiting
First Posted : April 5, 2017
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasms Drug: Gemcitabine Drug: Cisplatin Drug: Ipilimumab Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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]
Actual Study Start Date : September 8, 2017
Actual Primary Completion Date : December 3, 2019
Estimated Study Completion Date : June 7, 2021


Arm Intervention/treatment
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

Drug: Gemcitabine
Gemcitabine 1000 mg/m2 IV

Drug: Cisplatin
Cisplatin 25 mg/m2 IV

Drug: Nivolumab
Nivolumab 360 mg or 240 mg IV

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

Drug: Ipilimumab
Ipilimumab 1 mg/kg IV

Drug: Nivolumab
Nivolumab 360 mg or 240 mg IV




Primary Outcome Measures :
  1. The percentage of patients alive and without progression at 6 months following the initiation of treatment [ Time Frame: 6 Months ]
    The primary endpoint is PFS (Progression Free Survival) at 6 months following the initiation of treatment. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (irRECIST) definition.


Secondary Outcome Measures :
  1. The percentage of patients that respond to treatment [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest ]
    Overall response rate is defined as the sum of partial responses and complete responses. Partial and complete response will be defined as per irRECIST criteria.

  2. Median progression free survival time [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest ]
    The median time patients are alive without progression following the initiation of treatment wherein progression will be defined clinically or on imaging as per irRECIST criteria.

  3. Median overall survival time [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest ]
    The median overall survival time following the initiation of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101566


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Vaibhav Sahai, MBBS, MS University of Michigan Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03101566    
Other Study ID Numbers: UMCC 2017.026
HUM00126271 ( Other Identifier: University of Michigan )
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Nivolumab
Ipilimumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological