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

Resectable Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03768531
• Other study ID #: J18162
• Secondary ID: IRB00185328
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 14, 2019
• Est. completion date: January 2023

Study information

• Verified date: April 2020
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Resectable Biliary Tract Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Bristol-Myers Squibb

Outcome

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