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RecruitingLast updated: 16 August 2024

TILVANCE-301: This study is evaluating how safe and effective a new immunotherapy treatment called lifileucel is in combination with pembrolizumab immunotherapy, compared to pembrolizumab alone, in people with untreated melanoma that is metastatic or unable to be removed with surgeryA Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Skin Cancers Skin

Age

People18 - 70

Trial acronym

TILVANCE-301

Clinical summary

Summary

This study will enroll participants with unresectable (unable to be removed by surgery) or metastatic melanoma who have had no prior therapy for their metastatic disease. Previous adjuvant or neoadjuvant therapy with a single line of protooncogene B-raf (BRAF) inhibitor, with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 [CTLA] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease. 

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm A (Experimental), participants will receive lifileucel plus pembrolizumab. A tumour sample is resected from each patient for lifileucel manufacturing. Participants then receive pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Participants will then continue to receive pembrolizumab every 6 weeks until disease progression. 

In Arm B (Comparator Arm), participants will receive pembrolizumab alone with optional crossover period. Participants will receive pembrolizumab every 6 weeks until disease progression. Upon verified confirmed disease progression, participants may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria. 

Conditions

This trial is treating people with Stage IIIC, IIID, or IV unresectable or metastatic melanoma

Eligibility

Inclusion

  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

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Iovance Biotherapeutics, Inc.

Scientific Title

A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma

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