Study on Nivolumab With or Without Ipilimumab for Treating Advanced Anal Canal Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02314169
This clinical trial is exploring how well the drugs nivolumab, with or without ipilimumab, work in treating anal canal cancer that has spread and not responded to previous treatments. These drugs are a type of immunotherapy that may help the immune system fight cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is testing the effectiveness of the immunotherapy drugs nivolumab and ipilimumab in patients with anal canal cancer that has spread and not responded to previous treatments. The goal is to see if these drugs can help the immune system attack the cancer and stop it from growing and spreading.
Description
The study has two main parts:
Part A:
- Patients receive nivolumab through an IV every two weeks. The treatment continues as long as the cancer does not worsen and side effects are manageable. Patients will have regular scans and blood tests.
Part B:
- Patients are randomly assigned to one of two groups:
- Group 1: Receives nivolumab through an IV every four weeks.
- Group 2: Receives nivolumab as in Group 1, plus ipilimumab through an IV every eight weeks.
- Treatment continues as long as the cancer does not worsen and side effects are manageable. Patients will have regular scans and blood tests.
After finishing the treatment, patients will be monitored for 100 days and then every three months for two years to check their health and cancer status.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with metastatic squamous cell carcinoma of the anal canal that has been treated before.
- Have measurable cancer according to specific medical criteria.
- Have received at least one prior treatment for advanced or metastatic cancer.
- Be 18 years or older.
- Be in good overall health with a performance status score of 0 or 1.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
- Willing to sign an informed consent form and follow study procedures.
- Brain metastases are allowed if treated and stable for at least three months.
- Willing to undergo heart function tests if there is a history of heart issues.
- Willing to be tested for HIV and hepatitis, and meet specific health criteria if positive.
Exclusion Criteria
- Have had chemotherapy or radiotherapy within the last four weeks.
- Currently receiving other investigational treatments.
- Have had prior treatment with similar immunotherapy drugs.
- Have severe allergies to similar drugs.
- Have uncontrolled illnesses or infections.
- Have active autoimmune diseases requiring treatment.
- Require systemic steroid treatment above a certain dose.
- Have other cancers, except for certain treated skin cancers or early-stage cancers in remission.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
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