Study on Lifileucel and Pembrolizumab Combination Compared to Pembrolizumab Alone for Untreated Advanced Melanoma
Sponsor: Iovance Biotherapeutics, Inc.
ClinicalTrials ID:NCT05727904
This clinical trial is testing whether a combination of the drugs lifileucel and pembrolizumab is more effective than pembrolizumab alone in treating patients with advanced melanoma that has not been treated before.
Patient Parameters
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Program Overview
This study is designed to compare the effectiveness and safety of a new treatment combination, lifileucel and pembrolizumab, against pembrolizumab alone in patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body. If the cancer progresses in patients receiving only pembrolizumab, they may have the option to switch to lifileucel treatment.
Description
The trial is for patients with advanced melanoma (Stage IIIC, IIID, or IV) that cannot be surgically removed or has spread to other areas. Participants should not have received any prior treatment for their metastatic melanoma. However, if they have previously received certain treatments like BRAF inhibitors, MEK inhibitors, PD-1 inhibitors, or CTLA-4 inhibitors, it must have been completed at least 6 months before their cancer progressed to the metastatic stage. The study will help determine if the combination of lifileucel and pembrolizumab is more effective than pembrolizumab alone.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced melanoma (Stage IIIC, IIID, or IV) that cannot be surgically removed or has spread.
- Good overall health with a performance status score of 0 or 1 and expected to live more than 6 months.
- Have at least one tumor that can be removed for lifileucel treatment.
- Have at least one measurable tumor after surgery.
- Have good organ function.
- Agree to use effective birth control if of childbearing potential.
- Participants over 70 may join after discussion with the study doctor.
Exclusion Criteria
- Melanoma that started in the eye.
- Untreated brain tumors causing symptoms.
- More than one previous treatment for melanoma.
- Previous treatment for metastatic melanoma.
- BRAF V600 mutation-positive tumors treated only with certain therapies.
- Serious medical conditions that increase study risks, like infections or heart, lung, or immune system diseases.
- Any form of immune system deficiency.
- Another cancer within the last 3 years, unless it was treated and not likely to return.
- History of organ or cell transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham: The Kirklin Clinic | 35233 | Birmingham | Alabama |
| City of Hope | 91010 | Duarte | California |
| USC Norris Comprehensive Cancer Center | 90007 | Los Angeles | California |
| California Pacific Medical Center | 94107 | San Francisco | California |
| Orlando Health Cancer Institute | 32806 | Orlando | Florida |
| University of Illinois Hospital & Health Sciences System | 60612 | Chicago | Illinois |
| University of Kansas | 66205 | Kansas City | Kansas |
| University of Louisville - James Graham Brown Cancer Center | 40202 | Louisville | Kentucky |
| National Cancer Institute | 20814 | Bethesda | Maryland |
| Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center | 48201 | Detroit | Michigan |
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