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

Phase 1 Terminated 3 enrolled University of Iowa GlaxoSmithKline · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2022-07-07
Primary completion: 2024-11-18
Completion: 2025-11-24

Publications

Background Seyedin SN, Hasibuzzaman MM, Pham V, Petronek MS, Callaghan C, Kalen AL, Mapuskar KA, Mott SL, Spitz DR, Allen BG, Caster JM. Combination Therapy with Radiation and PARP Inhibition Enhances Responsiveness to Anti-PD-1 Therapy in Colorectal Tumor Models. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):81-92. doi: 10.1016/j.ijrobp.2020.01.030. Epub 2020 Feb 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dostarlimab	Monoclonal antibody	500 mg	Intravenous
Subject	Niraparib	Small molecule	100 mg	Oral
Subject	Niraparib	Small molecule	200 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications