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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT04926324
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Rectal Neoplasm Malignant
  • Rectal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib is a drug FDA-approved for use in maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • Dostarlimab — DRUG
    Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody medication used for the treatment of endometrial cancer.
  • Short course radiation — 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.

Study Details

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.

Key Dates

Start date
Jul 7, 2022
Status verified
Jun 2025
Primary completion
Nov 18, 2024
Completion
Dec 26, 2024

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (starting)
    niraparib, 100 mg orally once daily for up to 12 weeks dostarlimab, 500 mg infused (IV) once every 3 weeks for up to 12 weeks radiation therapy, 5 Gray (Gy) per day for 5 consecutive days
  • Experimental: Cohort 2
    niraparib, 200 mg orally once daily for up to 12 weeks dostarlimab, 500 mg infused (IV) once every 3 weeks for up to 12 weeks radiation therapy, 5 Gray (Gy) per day for 5 consecutive days

Primary Outcome Measure

Determination of recommended phase 2 niraparib dose [ Time Frame: From treatment day 1 for up to 16 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Holden Comprehensive Cancer Center at the University of IowaIowa CityIowa52242-

Find similar trials in Iowa City, IA

By research site
Holden Comprehensive Cancer Center at the University of Iowa· Iowa City, IA

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