Combining lifileucel with pembrolizumab for advanced melanoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, multicenter, open-label trial investigates the effectiveness and safety of lifileucel in combination with pembrolizumab compared to pembrolizumab alone in patients with untreated, unresectable or metastatic melanoma. Participants will be randomly assigned to receive either the combination therapy or pembrolizumab alone, with an option for crossover to lifileucel if their disease progresses. The study aims to enroll individuals with specific stages of melanoma who have not received prior treatment for metastatic disease, ensuring a focused evaluation of the new treatment regimen.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham: The Kirklin Clinic
  Birmingham, Alabama, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• Orlando Health Cancer Institute
  Orlando, Florida, United States Recruiting
• National Cancer Institute
  Bethesda, Maryland, United States Recruiting

+32 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Iovance Biotherapeutics https://www.tilvance-301.com
• Email: Clinical.Inquiries@iovance.com
• Phone: 1-844-845-4682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.