Neoplasms

Symptoms and General Pathology

All Conditions

Rare Diseases

Neoplasm Metastasis

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Dostarlimab

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Cycle 1-4 (cycle length 4 weeks): Niraparib 300 mg taken orally on days 1-21 and Dostarlimab 500 mg intravenously on day 1

Cycle 5 and above (cycle length 3 weeks): Niraparib 300 mg taken orally on days 1-21 and 1000 mg intravenously on day 1 of every other cycle

Walid Shaib, MD

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.

Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Molecularly Driven, Immune-Based, Maintenance Niraparib and Dostarlimab in Advanced Stage Cholangiocarcinoma

Evaluate PFS of patients who achieved a complete response (CR), partial response (PR) or stable disease (SD). PFS is defined as the date of treatment initiation (C1D1) until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs

ORR is the proportion of all subjects with confirmed PR or CR as the Best Overall Response according to RECIST 1.1, from treatment initiation (C1D1) until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).

OS is defined as the period measured from the date of treatment initiation (C1D1) to the date of death from any cause.

DoR is defined as the period measured from the time that RECIST 1.1 criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).

Disease control rate (DCR) is the percentage of subjects with SD, PR, or CR according to RECIST 1.1.

Adverse events will be assessed using the National Cancer Institution Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5

Spots Global Cancer Trial Database for Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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