NCT04926324

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rectal Neoplasms
• Rectal Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib is a drug FDA-approved for use in maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
DRUG	Dostarlimab	Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody medication used for the treatment of endometrial cancer.
RADIATION	Short course radiation	Participants will be treated with intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) to minimize mean dose to femoral, pelvic, and lumbar bone marrow. The entire mesorectum will be treated to a total dose of 25 Gy.

Timeline

• Start date: 2022-07-07
• Primary completion: 2024-11-18
• Completion: 2024-12-26
• First posted: 2021-06-15
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study