Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer

• ClinicalTrials.gov Identifier: NCT03768531
• Recruitment Status: Withdrawn
• First Posted: December 7, 2018
• Last Update Posted: April 13, 2020
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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
• Actual Study Start Date: June 14, 2019
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Bristol-Myers Squibb

Investigators

• Principal Investigator: Adrian Murphy, MD; Johns Hopkins Medical Institution

More Information

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT03768531
• Other Study ID Numbers: J18162; IRB00185328 ( Other Identifier: JHM IRB )
• First Posted: December 7, 2018
• Last Update Posted: April 13, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Nivolumab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action