Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03768531
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).

Condition or disease Intervention/treatment Phase
Resectable Biliary Tract Cancer Drug: Nivolumab Drug: Cabrilizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A: Nivolumab Drug: Nivolumab
Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).
Other Name: OPDIVO; BMS-936558-01

Experimental: Arm B: Nivolumab and Cabrilizumab
Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks).
Drug: Nivolumab
Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).
Other Name: OPDIVO; BMS-936558-01

Drug: Cabrilizumab
Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).
Other Name: FPA008, BMS-986227




Primary Outcome Measures :
  1. Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]
    Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 4 years ]
    Number of months from the date of first treatment until death or end of follow-up.

  2. Disease free survival (DFS) [ Time Frame: up to 4 years ]
    Number of months until disease recurrence.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has confirmed biliary tract cancer
  • Ability to understand and willingness to sign a written informed consent document.
  • Age ≥18 years
  • Have biopsiable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patient must have adequate organ function defined by the study-specified laboratory tests.
  • Must use acceptable form of birth control while on study.

Exclusion Criteria:

  • Has active autoimmune disease that requires systemic treatment.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
  • Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication.
  • Has received a blood transfusion within 72 hours prior to first dose of study drug administration
  • Unwilling or unable to follow the study schedule for any reason.
  • Major surgery within 4 weeks prior to initiation of study treatment.
  • Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breastfeeding women.
  • Have known history of infection with HIV, hepatitis B, or hepatitis C.
  • Received any prophylactic vaccine within 30 days of first dose of study drug treatment.
  • Has a history of allergy to study treatments or any of its components of the study.

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): NCT03768531


Contacts
Layout table for location contacts
Contact: Susan Sartorius-Mergenthaler, RN 410-614-3644 Sartosu@jhmi.edu
Contact: Jane Zorzi, RN 410-614-5818 Jzorzi1@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Susan Sartorius-Mergenthaler, RN    410-614-3644    Sartosu@jhmi.edu   
Contact: Jane Zorzi, RN    410-614-5818    Jzorzi1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Adrian Murphy, MD Johns Hopkins Medical Institution

Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03768531     History of Changes
Other Study ID Numbers: J18162
IRB00185328 ( Other Identifier: JHM IRB )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Nivolumab
Cabiralizumab
Immunotherapy
Anti-PD-1
Anti-CSF-1R
Biliary tract cancers (BTC)
Neoadjuvant chemotherapy
Adjuvant chemotherapy
Tumor microenvironment

Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents