Study on Talimogene Laherparepvec and Pembrolizumab for Treating Stage III-IV Melanoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02965716
This clinical trial is testing a combination of two treatments, talimogene laherparepvec and pembrolizumab, to see if they can help shrink tumors in patients with advanced melanoma (stage III-IV). These treatments work by boosting the immune system to fight cancer cells.
Patient Parameters
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Program Overview
This study is exploring how well two treatments, talimogene laherparepvec and pembrolizumab, work together to treat advanced melanoma. Talimogene laherparepvec is a biological therapy that uses substances from living organisms to help the immune system fight cancer. Pembrolizumab is an immunotherapy that helps the body's immune system attack cancer cells. The goal is to see if this combination can shrink tumors more effectively than previous treatments.
Description
The main goal of this study is to see how well the combination of talimogene laherparepvec (T-VEC) and pembrolizumab works in patients whose melanoma has progressed after previous treatments. Researchers will look at how many patients experience a reduction in tumor size, both in injected and non-injected areas, and how long patients live without the cancer getting worse. They will also study the safety of the treatment and any side effects.
Participants will receive talimogene laherparepvec injected directly into the tumor and pembrolizumab through an IV every 21 days, for up to 36 cycles, unless the cancer progresses or side effects become too severe. After finishing the treatment, patients will have follow-up visits every 6 months for a year, and then once a year for up to 5 years.
Researchers will also study how the treatment affects the immune system's ability to attack the cancer, including changes in immune cells and tumor characteristics.
Eligibility Criteria
Inclusion Criteria
- Have stage IV or unresectable stage III melanoma that cannot be treated with local therapy.
- Have measurable disease as determined by specific imaging tests.
- Be eligible for injections into skin, under the skin, or lymph node tumors.
- May have brain metastases if treated and stable without steroids for at least 14 days.
- Have previously been treated with anti-PD-1 or anti-PD-L1 therapy and shown disease progression.
- Be 18 years or older.
- Have a performance status score of 2 or less, indicating ability to carry out daily activities.
- Meet specific blood count and organ function criteria.
- Be willing to provide tissue and blood samples for research purposes.
- Sign an informed consent form agreeing to participate in the study.
Exclusion Criteria
- Cannot have visceral lesions if in Cohort B.
- Cannot have had recent surgery, biologic, hormonal, or chemotherapy treatments within 14 days before starting the study.
- Cannot have received talimogene laherparepvec before.
- Cannot have received a live vaccine within 30 days before starting the study.
- Cannot be planning to receive other cancer treatments during the study.
- Cannot require systemic corticosteroids or have severe autoimmune diseases needing treatment.
- Cannot have active infections or a history of certain viral infections.
- Cannot have organ transplants or uncontrolled illnesses that could interfere with the study.
- Cannot have active autoimmune diseases needing treatment in the past 2 years.
- Cannot have significant immunosuppression or other active cancers needing treatment.
- Cannot be pregnant or nursing, and must agree to use effective contraception during and after the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UCLA / Jonsson Comprehensive Cancer Center | 90095 | Los Angeles | California |
| Keck Medical Center of USC Pasadena | 91105 | Pasadena | California |
| Loyola University Medical Center | 60153 | Maywood | Illinois |
| Indiana University/Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| University of Kansas Hospital-Westwood Cancer Center | 66205 | Westwood | Kansas |
| Henry Ford Cancer Institute-Downriver | 48183 | Brownstown | Michigan |
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