Study on Nivolumab After Combined Therapy for High Risk Stage II-IIIB Anal Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03233711
This clinical trial is exploring whether the drug nivolumab, given after standard combined therapy, can help improve outcomes for patients with high risk stage II-IIIB anal cancer. Nivolumab is an immunotherapy that may help the immune system attack cancer cells and prevent them from growing and spreading.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this phase III study is to determine if using nivolumab after standard combined therapy can improve disease-free survival in patients with high risk anal cancer. Nivolumab is a type of immunotherapy that uses monoclonal antibodies to help the immune system target and destroy cancer cells. The study will compare the effects of nivolumab with observation (no additional treatment) to see which approach is more effective in preventing cancer from returning or progressing.
Description
The main goal of this study is to see if nivolumab can help patients with high risk anal cancer live longer without the disease coming back after they have completed standard combined therapy. The study will also look at other outcomes, such as how well patients respond to the treatment, how long they can live without needing a colostomy, and overall survival rates.
Participants in the study will be randomly assigned to one of two groups. One group will receive nivolumab through an IV, while the other group will be closely monitored without additional treatment. Throughout the study, participants will undergo various tests and procedures, including scans and blood tests, to track their progress and health.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of high risk stage IIB, IIIA, IIIB, or IIIC anal cancer.
- Must have a performance status score of 0-2, indicating good overall health.
- Must have adequate blood counts and organ function based on specific lab tests.
- HIV-positive patients are eligible if they meet certain health criteria and are receiving appropriate HIV treatment.
- Women of childbearing potential and sexually active men must agree to use effective contraception during the study and for several months after the last dose of nivolumab.
- Must not have any uncontrolled illnesses or conditions that could interfere with the study.
- Must not have received prior treatment with immune checkpoint inhibitors.
- Must not have received live vaccines within 30 days before starting the study.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Patients who have had a bone marrow or organ transplant.
- Patients with a history of different cancers unless they have been disease-free for at least 2 years.
- Patients with active autoimmune diseases that required treatment in the past 2 years.
- Patients with known lung diseases that could interfere with the study.
- Patients with a history of severe allergic reactions to similar drugs.
- Patients who have received other cancer treatments or experimental drugs at the same time as the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | 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 |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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