NCT04751370|Active Not RecruitingPhase 2FDA Drug

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

A Phase II Study of Neoadjuvant Nivolumab Plus Ipilimumab and Short-Course Radiation in MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2021-00912EA2201U10CA180820

Study Type

interventional

Target

Locations

1 country

Sites

215

Timeline

RegisteredFeb 2021

StartedFeb 2022

CompletionDec 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

8mo left

Started Feb 2022

Longer than P75 for phase_2

Geographic Reach

1 country

215 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.9 years study duration

Study Progress87%

Feb 2022Dec 2026

First Submitted

Initial submission to the registry

February 11, 2021

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed

12 months until next milestone

Study Start

First participant enrolled

February 8, 2022

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 1, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

February 11, 2021

Last Update Submit

April 30, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

Pathological complete response
At the time of total mesorectal excision

Secondary Outcomes (4)

Rate of sphincter preservation in low-lying tumors
Up to 5 years
Disease free survival
Up to 5 years
Overall survival
Up to 5 years
Incidence of adverse events
Up to 5 years

Study Arms (1)

Treatment (nivolumab, ipilimumab, radiation therapy, TME)

EXPERIMENTAL

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.

Procedure: Computed TomographyBiological: IpilimumabProcedure: Magnetic Resonance ImagingBiological: NivolumabRadiation: Radiation TherapyProcedure: SigmoidoscopyProcedure: Total Mesorectal Excision

Interventions

Computed TomographyPROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography