Neoplasms

All Conditions

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Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Fallopian Tube Diseases

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Peritoneal Diseases

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Ovarian Epithelial Cancer

Fallopian Tube Cancer

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Antibodies

Niraparib

Dostarlimab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Pancrelipase

Pancreatin

Immunologic Factors

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients receive niraparib PO QD on days 1-28 of cycle 1. Beginning cycle 2, patients receive niraparib PO QD on days 1-21 and dostarlimab intravenously (IV) on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 6, patients receive niraparib PO QD on days 1-42 and dostarlimab IV on day 1. Cycles repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Elizabeth M. Swisher

This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as TSR-042, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and TSR-042 may kill more cancer cells.

OUTLINE:

Patients receive niraparib orally (PO) once daily (QD) on days 1-28 of cycle 1. Beginning cycle 2, patients receive niraparib PO QD on days 1-21 and dostarlimab intravenously (IV) on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 6, patients receive niraparib PO QD on days 1-42 and dostarlimab IV on day 1. Cycles repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days, every 6 months for 2 years, and then annually for up to 5 years.

Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

Phase IB Trial of Niraparib and TSR-042 in Patients With BRCA-Mutated Breast, Pancreas or Ovary Cancer

Will be defined as a complete response (CR) or partial response (PR), confirmed and unconfirmed, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 using investigator's review.

Will assess events leading to dose reduction, events leading to permanent treatment discontinuation, overall incidence and Common Terminology Criteria for Adverse Events criteria grade of adverse events, as well as relatedness of adverse events to treatment, incidence of great 2 or greater non-hematologic toxicity and grade 3 or 4 hematologic toxicity, causes of death.

Progression will be assessed by method (RECIST v.1.1 etc.) criteria using (independent central or investigator's) review. PFS for patients last known to be alive and progression-free will be censored at the date of last follow-up.

Will be assessed by RECIST version 1.1 using investigator's review. DOR for patients last known to be alive and progression-free will be censored at the date of last follow-up.

Will be defined as a best response of CR, PR or stable disease (SD) (of at least 6 months) as assessed by RECIST version 1.1 using investigator's review. DC for patients not known to have a best response of CR or PR, or SD for at least 6 months from the start of study treatment will be coded as lacking disease control.

GlaxoSmithKline

University of Washington

Spots Global Cancer Trial Database for unresectable ovarian carcinoma