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Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer

NCT04751370 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-05-01

No results posted yet for this study

Summary

This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.

Conditions

  • Locally Advanced Rectal Adenocarcinoma
  • Stage II Rectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8

Interventions

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

RADIATION

Radiation Therapy

Undergo short-course radiation therapy

PROCEDURE

Sigmoidoscopy

Undergo sigmoidoscopy

PROCEDURE

Total Mesorectal Excision

Undergo TME

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kristen K Ciombor · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751370 on ClinicalTrials.gov