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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03768531

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Arms

42.6

Anticipated Duration (Months)

Study Details

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

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 :

Jun 14, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 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 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

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

Outcome Measures

Primary Outcome Measures

Number of participants experiencing study drug-related toxicities [4 years]
Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.