Spots Global Cancer Trial Database for A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers

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Trial Identification

Brief Title: A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers

Official Title: A Phase 1b/2 Trial of Preoperative Niraparib, Dostarlimab, and Hypofractionated Radiotherapy for the Treatment of Locally-advanced Rectal Cancers.

Study ID: NCT04926324

Conditions

Rectal Neoplasms

Rectal Neoplasm Malignant

Interventions

Niraparib

Dostarlimab

Short course radiation

Study Description

Brief Summary: This clinical trial is designed to determine the maximum tolerated dose of niraparib when combined with dostarlimab and hypofractionated radiation for locally advanced rectal cancer. Once this is determined, this dose will be tested to identify what impact it has on the tumor as well as patient reported outcome measures.

Detailed Description: Standard of care therapy for resectable locally advanced rectal cancer includes pelvic radiation (short or long course), chemotherapy, and (if indicated) surgery. In this study, participants will: * Take niraparib by mouth once daily for up to 12 weeks. * Receive radiation therapy once daily for five days (Monday through Friday). * Receive intravenous (IV) dostarlimab once every three weeks for up to 12 weeks. * Provide feedback about how they feel and their quality of life. This is done through short surveys as well as discussing with the study team. * Undergo a sigmoidoscopy (i.e. scope of the tumor) and biopsy about halfway through treatment * Provide tumor tissue and blood samples for analysis