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

Conditions

• Melanoma
• Metastatic Melanoma
• Unresectable Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Lifileucel plus Pembrolizumab — BIOLOGICAL
  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.
• Pembrolizumab with Optional Crossover Period — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Mar 30, 2023

Status verified

Apr 2026

Primary completion

Mar 1, 2028

Completion

Mar 1, 2030

Study Design

Enrollment

670 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Lifileucel plus Pembrolizumab
• Active Comparator: Arm B
  Pembrolizumab alone with Optional Crossover Period

Primary Outcome Measure

Objective Response Rate and Progression Free Survival [ Time Frame: 5 years total duration ]

Central Contacts

• Iovance Biotherapeutics https://www.tilvance-301.com
  1-844-845-4682
  [email protected]
• Iovance Biotherapeutics Study Team
  1-844-845-4682
  [email protected]

Locations (22)

Find similar trials in Birmingham, AL

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