Study Comparing Pembrolizumab with Other Treatments for High-Risk Melanoma After Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02506153
This clinical trial is comparing the effectiveness of pembrolizumab against other standard treatments chosen by doctors and patients, such as high-dose interferon alfa-2B or ipilimumab, in patients with stage III-IV melanoma that has been surgically removed but is at high risk of returning or spreading.
Patient Parameters
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Program Overview
The purpose of this study is to determine if pembrolizumab is more effective than the current standard treatments, which include high-dose interferon alfa-2B or ipilimumab, in preventing the return or spread of melanoma after surgery. These treatments work by helping the immune system attack cancer cells and may slow down or stop the growth of tumors. The study will also look at how safe these treatments are and how they affect patients' quality of life.
Description
This study aims to compare the overall survival and relapse-free survival of patients with stage III-IV melanoma who have had their tumors surgically removed. Participants will be randomly assigned to receive either pembrolizumab or a treatment chosen by their doctor and themselves, which could be high-dose interferon alfa-2B or ipilimumab. The study will also evaluate the safety and side effects of these treatments, as well as their impact on patients' quality of life.
Participants will undergo regular scans and blood tests to monitor their health and the effectiveness of the treatment. After completing the treatment, patients will have follow-up visits to check for any signs of cancer returning or spreading. The study will also collect tissue and blood samples for future research.
The trial will explore the relationship between certain genetic markers and the effectiveness of the treatments, as well as the presence of circulating tumor DNA and its association with cancer relapse. Participants will be closely monitored for any side effects and will receive support throughout the study.
Eligibility Criteria
Inclusion Criteria
- Must have had stage III or IV melanoma that has been completely removed by surgery.
- Melanoma must be of skin origin or unknown primary origin, but not from the eyes.
- Must not have a history of brain metastases.
- Must have had all current disease surgically removed with no evidence of remaining cancer.
- Must be willing to provide tissue samples for testing.
- Must not have received prior immunotherapy or neoadjuvant treatment for melanoma.
- Must have a good overall health status and meet specific blood test criteria.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
- Must be willing to participate in quality of life assessments if able to complete questionnaires in English, Spanish, or French.
- Must provide informed consent to participate in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Virginia G Piper Cancer Care-Del Camino | 85258 | Scottsdale | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Highlands Oncology Group - Rogers | 72758 | Rogers | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
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