TITRE |
(EN) 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 |
PROTOCOLE ID |
TILVANCE-301 |
CLINICAL TRIAL.gov ID |
NCT05727904 |
TYPE(S) DE CANCER |
Mélanome |
PHASE |
Phase III |
TYPE D'ÉTUDE |
Clinique |
INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Rahima Jamal
|
COORDONATEUR(RICE) |
Adeline Hamon parc.eligibilite.chum@ssss.gouv.qc.ca 514-890-8000 poste 30737
|
STATUT |
Actif en recrutement
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
- 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.
- Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
- Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
- Participants must have adequate organ function.
- Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
- Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
|
CRITÈRES D'EXCLUSION |
(EN)
- Participant has melanoma of uveal/ocular origin.
- Participant has symptomatic untreated brain metastases.
- Participant received more than 1 prior line of therapy.
- Participant received prior therapy for metastatic disease
- Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
- 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.
- Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
- 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.)
- Participant has a history of allogeneic cell or organ transplant.
Other protocol defined inclusion/exclusion criteria could apply.
|