Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Launched by IOVANCE BIOTHERAPEUTICS, INC. · Feb 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced melanoma, which is a serious type of skin cancer. Researchers want to see if combining two medications, lifileucel and pembrolizumab, works better than using pembrolizumab alone for patients who have not received treatment before and have melanoma that cannot be removed by surgery or has spread to other parts of the body. If participants in the pembrolizumab-only group experience disease progression (meaning their cancer worsens), they may have the opportunity to receive the lifileucel treatment as well.

To be eligible for this trial, participants must have a confirmed diagnosis of specific advanced stages of melanoma and meet certain health criteria, such as having a good performance status and adequate organ function. The trial welcomes adults of all genders aged 18 and older. Participants can expect regular check-ups and monitoring throughout the study to ensure their safety and track how well the treatments are working. It's important to note that this trial is currently recruiting participants, so there is an opportunity to take part in this potentially beneficial research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
• • 2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
• • 3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
• • 4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
• • 5. Participants must have adequate organ function.
• • 6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
• • 7. Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
• Exclusion Criteria:
• • 1. Participant has melanoma of uveal/ocular origin.
• • 2. Participant has symptomatic untreated brain metastases.
• • 3. Participant received more than 1 prior line of therapy.
• • 4. Participant received prior therapy for metastatic disease
• • 5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
• • 6. Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• • 7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
• • 8. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
• • 9. Participant has a history of allogeneic cell or organ transplant.
• • Other protocol defined inclusion/exclusion criteria could apply.