Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy

Phase 2

Active, not recruiting

• Conditions: Biliary Tract Cancer
• Interventions: Drug: Rucaparib; Drug: Nivolumab

• Registration Number: NCT03639935
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2019-03-28
• Primary Completion: 2023-02-07
• Results First Submitted: 2024-02-09
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Results First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rucaparib and Nivolumab	Nivolumab	Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15
Rucaparib and Nivolumab	Rucaparib	Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months	4 months	Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.; A clinical decision of progression by the site investigator will be based on the subject's overall clinical condition, including performance status, clinical symptoms, and laboratory data.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) Time as Measured From Treatment Start	Up to two years post treatment discontinuation
The Proportion of Patients That Respond to Treatment	Up to two years post treatment start	The proportion of patients that display a partial response (PR) or complete response (CR) to treatment.; Partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.; Complete response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.
Progression Free Survival (PFS) Time as Measured From Treatment Start	Up to two years post treatment discontinuation	Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Progression Free Survival (PFS) Time as Measured From Start of 1st Line Platinum Therapy	Up to two years post treatment discontinuation	Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Overall Survival (OS) Time as Measured From Start of 1st Line Platinum Therapy	Up to two years post treatment discontinuation

Trial Locations

Locations (3)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States