Study on Nivolumab and Ipilimumab with Short-Course Radiation for Locally Advanced Rectal Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04751370
This clinical trial is exploring the effects of combining two immunotherapy drugs, nivolumab and ipilimumab, with short-course radiation therapy to treat rectal cancer that has spread to nearby tissues or lymph nodes. The study aims to see if this combination can help the immune system better attack the cancer and improve treatment outcomes.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is testing a combination of two immunotherapy drugs, nivolumab and ipilimumab, along with short-course radiation therapy to treat rectal cancer that has spread locally. Immunotherapy helps the body's immune system fight cancer, while radiation therapy uses high-energy x-rays to kill cancer cells. The goal is to see if this combination can kill more cancer cells and improve treatment results for patients with locally advanced rectal cancer.
Description
The main goal of this study is to see if using nivolumab and ipilimumab with short-course radiation before surgery can increase the rate of complete cancer disappearance in patients with a specific type of rectal cancer. Researchers also want to find out if this treatment can help preserve the sphincter in low-lying tumors, improve survival rates, and ensure the treatment is safe.
Patients will receive nivolumab and ipilimumab through an IV on the first day of treatment, repeating every 28 days for two cycles. After these cycles, patients will undergo short-course radiation therapy for one week. Following radiation, patients will continue with nivolumab and ipilimumab for another two cycles. Surgery will take place 8-12 weeks after the last cycle. Patients will also have MRI and CT scans before surgery and during follow-up, along with a sigmoidoscopy before surgery.
After completing the treatment, patients will be monitored for five years to track their progress and health.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of rectal adenocarcinoma within 15 cm from the anal verge.
- Have stage II or III rectal cancer based on recent imaging scans.
- Have tumors with specific genetic markers (MSI-H or dMMR).
- Be in good overall health with an ECOG performance status of 0-2.
- Have not received previous chemotherapy, immunotherapy, or pelvic radiotherapy for rectal cancer.
- Be able to understand and sign a consent form, or have a representative to do so.
- Not have had major surgery within 28 days before joining the study.
- Not have lung disease or serious infections requiring IV antibiotics.
- Agree not to receive live vaccines during the study.
- Not have active autoimmune diseases or require high-dose steroids.
- Not be pregnant or breastfeeding, and agree to use effective contraception.
- Meet specific blood count and organ function criteria.
- Have controlled HIV, hepatitis B, or hepatitis C infections if applicable.
- Not have had live vaccines within 30 days before joining the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
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