Loading clinical trials...
Loading clinical trials...
A Phase 1b/2 Trial of Preoperative Niraparib, Dostarlimab, and Hypofractionated Radiotherapy for the Treatment of Locally-advanced Rectal Cancers.
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa, United States
Start Date
July 7, 2022
Primary Completion Date
November 18, 2024
Completion Date
December 26, 2024
Last Updated
June 29, 2025
3
ACTUAL participants
Niraparib
DRUG
Dostarlimab
DRUG
Short course radiation
RADIATION
Lead Sponsor
University of Iowa
Collaborators
NCT06662786
NCT06663319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05239741