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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Computed Tomography — PROCEDURE
  Undergo CT
• Ipilimumab — BIOLOGICAL
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV
• Radiation Therapy — RADIATION
  Undergo short-course radiation therapy
• Sigmoidoscopy — PROCEDURE
  Undergo sigmoidoscopy
• Total Mesorectal Excision — PROCEDURE
  Undergo TME

Study Details

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.

Key Dates

Start date

Feb 8, 2022

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

31 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (nivolumab, ipilimumab, radiation therapy, TME)
  Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles. Starting at least 2 weeks but no longer than 6 weeks after completion of cycle 2 of nivolumab and ipilimumab, patients undergo short-course radiation therapy of 5 fractions daily for 1 week. Patients then continue to receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 8-12 weeks after completion of 4th cycle of nivolumab and ipilimumab, patients undergo TME. Patients also undergo MRI and CT prior to TME and during follow up, and undergo sigmoidoscopy prior to TME.

Primary Outcome Measure

Pathological complete response [ Time Frame: At the time of total mesorectal excision ]

Locations (215)

Find similar trials in Mobile, AL

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