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Contact Information:

Iovance Biotherapeutics Study Team 1-844-845-4682
Clinical.Inquiries@iovance.com


Iovance Biotherapeutics https://www.tilvance-301.com 1-844-845-4682
Clinical.Inquiries@iovance.com


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Be Part of Research - Trial Details - Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
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Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Recruiting

Open to: ALL

Age: 18.0 - 70.0

London Chelsea Newcastle upon Tyne London Glasgow Birmingham

Medical Conditions

Melanoma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2023 Mar 2028

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression.

Intervention Arm Group : Arm A;

Intervention Type : BIOLOGICAL
Intervention Description : Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria.

Optional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2.

Intervention Arm Group : Arm B;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guy's Hospital
    London
    SE1 9RT
  • Royal Marsden Hospital
    Chelsea
    London
    SW3 6JJ
  • Freeman Hospital
    Newcastle upon Tyne
    England
    NE7 7DN
  • Sarah Cannon Research Institute UK
    London
    W1G 6AD
  • Beaston West of Scotland Canter Centre
    Glasgow
    G120YN
  • Queen Elizabeth Hospital Birmingham
    Birmingham
    England
    B15 2GW

Iovance Biotherapeutics https://www.tilvance-301.com 1-844-845-4682
Clinical.Inquiries@iovance.com


Iovance Biotherapeutics Study Team 1-844-845-4682
Clinical.Inquiries@iovance.com



The study is sponsored by Iovance Biotherapeutics, Inc.



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Read full details for Trial ID: NCT05727904
Last updated 18 April 2025

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