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Checkpoint Inhibitor

Radiation Therapy for Rectal Cancer

Phase 2

Waitlist Available

Led By Kristen K Ciombor

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing immunotherapy and radiation therapy to treat rectal cancer that has spread.

Eligible Conditions

Locally Advanced Rectal Cancer
Rectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathological complete response

Secondary outcome measures

Disease free survival

Incidence of adverse events

Overall survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, ipilimumab, radiation therapy, TME)Experimental Treatment7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Ipilimumab

2014

Completed Phase 3

~2670

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Radiation Therapy

2017

Completed Phase 3

~7250

Nivolumab

2014

Completed Phase 3

~4750

Sigmoidoscopy

2007

Completed Phase 2

~140

Total Mesorectal Excision

2016

Completed Phase 3

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,122 Total Patients Enrolled

Kristen K CiomborPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

14 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many facilities are administering this trial?

"The trial is currently running in 94 different locations, including Coon Rapids, Saint Paul and Bozeman. To reduce unnecessary travelling demands for participants, it is advised to pick a nearby clinic when enrolling."

Answered by AI

Has Radiation Therapy been accorded regulatory authorization by the FDA?

"There is some existing evidence of radiation therapy's safety, so it was rated a 2. Unfortunately, this trial has not yet yielded data supporting its efficacy."

Answered by AI

What medical conditions often necessitate Radiation Therapy?

"Radiation therapy is frequently used following anti-angiogenic treatments, with additional applications in cases of malignant neoplasms, melanoma that can't be removed surgically and squamous cell carcinomas."

Answered by AI

What other research has been conducted with regard to the efficacy of Radiation Therapy?

"At this moment, 764 studies are looking into the efficacy of Radiation Therapy with 86 in Phase 3. While many Pittsburgh-based trials focus on Radiation Therapy, a total of 42751 locations around the globe have clinical trials running for it."

Answered by AI

Are there still opportunities to participate in this research endeavor?

"Affirmative. Clinicaltrials.gov data substantiates this clinical trial's active recruitment of participants, which began on May 13th 2021 and was last modified October 28th 2022. Across 94 different sites, 31 patients are being enrolled into the study."

Answered by AI

How many volunteers are engaging in this medical study?

"Affirmative. Data hosted on clinicaltrials.gov points to this medical trial's active recruitment status, which began in May 2021 and was recently updated in October 2022. 31 participants must be gleaned from 94 distinct sites for the study to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04751370.