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

Primary Purpose

Resectable Biliary Tract Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Nivolumab

Cabrilizumab

About this trial

This is an interventional treatment trial for Resectable Biliary Tract Cancer focused on measuring Nivolumab, Cabiralizumab, Immunotherapy, Anti-PD-1, Anti-CSF-1R, Biliary tract cancers (BTC), Neoadjuvant chemotherapy, Adjuvant chemotherapy, Tumor microenvironment

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: Nivolumab

Arm B: Nivolumab and Cabrilizumab

Arm Description

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).

Outcomes

Primary Outcome Measures

Number of participants experiencing study drug-related toxicities

Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0

Secondary Outcome Measures

Overall survival (OS)

Number of months from the date of first treatment until death or end of follow-up.

Disease free survival (DFS)

Number of months until disease recurrence.

Full Information

NCT ID

NCT03768531

First Posted

December 5, 2018

Last Updated

April 9, 2020

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03768531

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No subjects were enrolled

Study Start Date

June 14, 2019 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Biliary Tract Cancer

Keywords

Nivolumab, Cabiralizumab, Immunotherapy, Anti-PD-1, Anti-CSF-1R, Biliary tract cancers (BTC), Neoadjuvant chemotherapy, Adjuvant chemotherapy, Tumor microenvironment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Nivolumab

Arm Type

Experimental

Arm Title

Arm B: Nivolumab and Cabrilizumab

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

OPDIVO; BMS-936558-01

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Cabrilizumab

Other Intervention Name(s)

FPA008, BMS-986227

Intervention Description

Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).

Primary Outcome Measure Information:

Title

Number of participants experiencing study drug-related toxicities

Description

Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

Number of months from the date of first treatment until death or end of follow-up.

Time Frame

4 years

Title

Disease free survival (DFS)

Description

Number of months until disease recurrence.

Time Frame

up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Murphy, MD

Organizational Affiliation

Johns Hopkins Medical Institution

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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