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Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

NCT04895046 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-06-29

No results posted yet for this study

Summary

Phase II, single arm trial, evaluating molecularly selected, immune-based combination therapy in maintenance treatments for advanced cholangiocarcinoma, selecting patients on the homologous recombination deficient (HRD) signature.

Conditions

Interventions

DRUG

Niraparib

300 mg taken orally (all cycles)

DRUG

Dostarlimab

500 mg (cycles 1-4) intravenously

DRUG

Dostarlimab

1000 mg (cycle 5+) intravenously

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Walid Shaib, MD

    lead OTHER

Principal Investigators

  • Walid Shaib, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2022-09-30
Completion
2023-09-30
FDA Drug
Yes

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895046 on ClinicalTrials.gov