NCT05727904 Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
| NCT ID | NCT05727904 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Iovance Biotherapeutics, Inc. |
| Condition | Metastatic Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 670 participants |
| Start Date | 2023-03-30 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 670 participants in total. It began in 2023-03-30 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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.
Contact & Investigator
Iovance Biotherapeutics https://www.tilvance-301.com
✉ Clinical.Inquiries@iovance.com📞 1-844-845-4682
Iovance Biotherapeutics Study Team
STUDY DIRECTOR
Iovance Biotherapeutics
Frequently Asked Questions
Who can join the NCT05727904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Metastatic Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05727904 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 670 participants.
Is NCT05727904 currently recruiting?
Yes, NCT05727904 is actively recruiting participants. Contact the research team at Clinical.Inquiries@iovance.com for enrollment information.
Where is the NCT05727904 trial being conducted?
This trial is being conducted at Birmingham, United States, Duarte, United States, Los Angeles, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT05727904 clinical trial?
NCT05727904 is sponsored by Iovance Biotherapeutics, Inc.. The principal investigator is Iovance Biotherapeutics Study Team at Iovance Biotherapeutics. The trial plans to enroll 670 participants.
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