Nivolumab + Ipilimumab for Rectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take certain medications like high-dose corticosteroids or immunosuppressive drugs within 14 days before starting the trial. It's best to discuss your specific medications with the trial team.
What are the safety concerns of using Nivolumab and Ipilimumab in cancer treatment?
How does the drug combination of nivolumab and ipilimumab differ from other treatments for rectal cancer?
The combination of nivolumab and ipilimumab is unique because it uses the body's immune system to fight cancer, unlike traditional chemotherapy. This approach, known as immunotherapy, has shown effectiveness in other cancers like melanoma and lung cancer, and it may offer a new option for rectal cancer patients, especially those with specific genetic markers.678910
What data supports the effectiveness of the drug combination of Nivolumab and Ipilimumab for rectal cancer?
Research shows that the combination of Nivolumab and Ipilimumab has been effective in treating other types of cancer, such as advanced non-small cell lung cancer and metastatic colorectal cancer, by improving survival rates and achieving higher response rates compared to using Nivolumab alone.610111213
Who Is on the Research Team?
Kristen K Ciombor
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab and ipilimumab intravenously every 28 days for 2 cycles, followed by short-course radiation therapy for 1 week, and then continue with nivolumab and ipilimumab for another 2 cycles
Surgery
Participants undergo total mesorectal excision (TME) 8-12 weeks after completion of the 4th cycle of nivolumab and ipilimumab
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI, CT, and sigmoidoscopy
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Radiation Therapy
Ipilimumab is already approved in United States, European Union for the following indications:
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor