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

Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer

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).

Study Overview

• Status: Withdrawn
• Conditions: Resectable Biliary Tract Cancer
• Intervention / Treatment: Drug: Nivolumab; Drug: Cabrilizumab

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: FPA008, BMS-986227

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants experiencing study drug-related toxicities	Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Number of months from the date of first treatment until death or end of follow-up.	4 years
Disease free survival (DFS)	Number of months until disease recurrence.	up to 4 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Adrian Murphy, MD, Johns Hopkins Medical Institution

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Nivolumab; Adjuvant chemotherapy; Immunotherapy; Anti-PD-1; Neoadjuvant chemotherapy; Tumor microenvironment; Cabiralizumab; Anti-CSF-1R; Biliary tract cancers (BTC)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: J18162; IRB00185328 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No