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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Rectal Cancer

Great Falls, MT

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

No Placebo-Only Group

Summary

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

Who is the study for?

This trial is for adults with locally advanced rectal cancer that hasn't spread far and can be measured by MRI or CT scans. Participants must have a certain level of white blood cells, liver and kidney function, not be pregnant or planning to become pregnant, use contraception, and not have had major surgery or pelvic radiation before. They should also not have active autoimmune diseases or need immune-suppressing steroids.

What is being tested?

The study tests combining two immunotherapy drugs (Nivolumab and Ipilimumab) with short-course radiation therapy to see if they help the body fight rectal cancer better. The goal is to determine whether this combination can more effectively kill cancer cells in patients whose tumors haven't spread widely but are locally advanced.

What are the potential side effects?

Possible side effects include typical reactions from immunotherapy such as fatigue, skin issues, inflammation in organs like the intestines or lungs (colitis or pneumonitis), hormonal gland problems (like thyroid dysfunction), infusion-related reactions, and potential worsening of pre-existing autoimmune conditions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease free survival

Incidence of adverse events

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2440

Ipilimumab

2015

Completed Phase 3

~3380