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

Recruiting Phase 3 Interventional Study
Metastatic Melanoma Unresectable Melanoma Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
670 (estimated)
Sponsor
Iovance Biotherapeutics, Inc. · Industry
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About This Trial
This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verifi…
Trial Locations
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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 est…
Contacts

Iovance Biotherapeutics https://www.tilvance-301.com

1-844-845-4682

Clinical.Inquiries@iovance.com

CONTACT

Iovance Biotherapeutics Study Team

1-844-845-4682

Clinical.Inquiries@iovance.com

CONTACT