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A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma (PERTIL-01)

11 juin 2026 mis à jour par: Dr Ben Carnley, East Metropolitan Health Service, Australia

PERTIL-01: A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma

The goal of this study is to determine the activity of Perkileucel, a tumour infiltrating lymphocyte (TIL) adoptive cell transfer therapy (ACT), in patients with unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting.

Study details:

All participants will receive the investigational treatment, Perkileucel. To create this therapy, participants need to undergo surgical excision of a melanoma lesion to harvest the TILs prior to treatment. Once the TILs have been manufactured, participants will be admitted to hospital to receive 5 days of chemotherapy to prepare their body (lymphodepletion) for the TIL-ACT. Treatment with TIL-ACT will then be given on Day 0 as a single intravenous infusion followed by up to 6 intravenous infusions of high-dose interleukin 2. Blood tests and other assessments will be performed regularly to monitor safety and response.

The total duration of the study is 8 years. Safety will be assessed throughout the full duration of the study. Patients will be monitored for delayed adverse events.

This study will show whether Perkileucel can help control melanoma that has not responded to other treatments and demonstrate feasibility of manufacture and delivery of this treatment in an Australian healthcare setting.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a single arm, open label phase II study to determine the activity of Perkileucel, a tumour infiltrating lymphocyte (TIL) adoptive cell transfer therapy (ACT), in patients with unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting.

Patients with sufficient and accessible tumour tissue measuring at least 1.5 cm will undergo surgical excision. Harvested tumour tissue will be cultured at CTTWA and TIL will be expanded within 5 weeks.

Five days prior to infusion of TIL-ACT, patients will receive a nonmyeloablative lymphodepleting regimen with cyclophosphamide (60 mg/kg) once daily concurrently with fludarabine (25 mg/m^2) IV once daily for 2 days followed by fludarabine (25mg/m^2) once daily for 3 days.

Patients will then receive a single dose of TIL-ACT of 1 × 10^9 to 2 × 10^11 TIL intravenously on Day 0. Patients will receive up to 6 doses of intravenous high-dose interleukin-2 (600 000 IU/kg IV) every 8-12 hours.

The total inpatient stay from chemotherapy to recovery after IL-2 will be approximately 15 days.

Blood tests and imaging assessments will be performed regularly to monitor safety and response.

The total duration of the study is 8 years. Safety will be assessed throughout the full duration of the study. Patients will be monitored for delayed adverse events.

The assessment of the activity of TIL ACT in patients unresectable or metastatic melanoma resistant to anti-PD1 will be performed using best objective response rate as per RECIST criteria 1.1.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Australie
    • Western Australia
      • Perth, Western Australia, Australie, 6000

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Adult patients = 18 years = 70 years of age.
  2. ECOG 0-1 (Appendix A: Eastern Cooperative Oncology Group Performance Status Scale) with an estimated life expectancy of > 6 months
  3. Histologically confirmed unresectable or stage IV melanoma as per AJCC 8th edition. Unresectable melanoma is defined where the lesions are deemed to be unresectable by the treating surgeon.
  4. Metastatic melanoma with at least 1 surgically accessible metastatic lesion (or aggregate lesions) with an estimated minimum diameter of = 1.5 cm
  5. Measurable disease per RECIST 1.1 criteria (in addition to the resected lesion).
  6. At least one anti-PD1 containing line of systemic therapy for unresectable or metastatic melanoma. Alternatively, one prior line of an adjuvant or neoadjuvant anti-PD1 containing regimen and all related adverse events have either returned to baseline or stabilized.

Exclusion Criteria:

  1. Life expectancy of less than 3 months.
  2. Metastatic uveal melanoma.
  3. Requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs (e.g. mycophenolate, infliximab, or others) within the last 3 weeks prior to patient screening. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at =10 mg/day of prednisone or another steroid equivalent dose are acceptable.

  4. Participant has symptomatic untreated brain metastases.

    • A participant with historically treated brain metastases (ie, treatment was completed >60 days prior to consenting for study participation) may be considered for study participation if the participant is clinically and radiologically stable for = 60 days
    • Participants with previously known asymptomatic brain metastases who do not clinically require treatment may be enrolled.
  5. More than three melanoma brain metastases or evidence of leptomeningeal disease

Other protocol defined exclusion criteria could apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Tumour infiltrating lymphocytes adoptive cell therapy (TIL-ACT)

Patients with sufficient and accessible tumour tissue measuring at least 1.5 cm will undergo surgical excision. Harvested tumour tissue will be cultured at CTTWA and TILs will be expanded within 5 weeks. Five days prior to infusion of TIL-ACT, patients will receive a nonmyeloablative lymphodepleting regimen with cyclophosphamide (60 mg/kg) once daily concurrently with fludarabine (25 mg/m^2) IV once daily for 2 days followed by fludarabine (25mg/m^2) once daily for 3 days.

Patients will then receive 1 × 10^9 to 2 × 10^11 TILs intravenously on Day 1. Patients will receive up to 6 doses of intravenous IL-2 (600 000 IU/kg IV) every 8-12 hours post infusion of the TILs
Biologique: Tumour Infiltrating Lymphocytes Adoptive Cell Therapy
TILs are autologous melanoma reactive cells, that are harvested from patient's own melanoma tissue. Patients will receive the TIL-ACT by a single intravenous infusion on Day 0 at of dose of 5 x 10^9 to 2 x 10^11 TILs.
Médicament: Cyclophosphamide + Fludarabine Lymphodepletive Conditioning
Five days prior to infusion of TIL-ACT, patients will receive a lymphodepleting chemotherapy with cyclophosphamide (60 mg/kg) once daily concurrently with fludarabine (25 mg/m^2) IV once daily for 2 days followed by fludarabine (25mg/m^2) once daily for 3 days.
Autres noms:
  • Flu-Cy
Médicament: Aldesleukin
Patients will receive up to 6 doses of intravenous aldesleukin (600 000 IU/kg IV) every 8-12 hours post the TIL-ACT infusion.
Autres noms:
  • Interleukine-2

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Assess the activity of TIL ACT in patients unresectable or metastatic melanoma resistant to anti-PD1 using objective response rate as per RECIST 1.1
Délai: From enrolment to 6 months, date of documented progression per RECIST criteria 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first
Best objective response rate as per RECIST criteria 1.1
From enrolment to 6 months, date of documented progression per RECIST criteria 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Median Progression Free Survival
Délai: From enrolment to 12 months post infusion of Perkileucel
Median, calculated as the date between randomisation and the date of documented progression per RECIST 1.1 to month 12 post Perkileucel infusion
From enrolment to 12 months post infusion of Perkileucel
Median Overall Survival
Délai: From enrolment to 12 months post infusion of Perkileucel
Median, calculated by the date from randomisation to 12 months post Perkileucel infusion, or date of death
From enrolment to 12 months post infusion of Perkileucel
Median Progression Free Survival
Délai: From enrolment to 24 months post Perkileucel infusion
Median, calculated as the date between randomisation and the date of documented progression per RECIST 1.1 to month 24 post Perkileucel infusion
From enrolment to 24 months post Perkileucel infusion
Median Overall Survival
Délai: From enrolment to 24 months post Perkileucel infusion
Median, calculated by the date from randomisation to 24 months post Perkileucel infusion, or date of death
From enrolment to 24 months post Perkileucel infusion
Safety Analysis of Perkileucel
Délai: From enrolment to Day 100 post infusion of Perkileucel
Safety analyses will be performed in all treated patients. Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 by treatment group. All on-study AEs, treatment-related AEs, SAEs and treatment-related SAEs will be tabulated using worst grade per NCI CTCAE v6.0 criteria by system organ class and preferred term. On-study lab parameters including haematology, chemistry, liver function, and renal function will be summarised using worst grade NCI CTCAE v6.0 criteria.
From enrolment to Day 100 post infusion of Perkileucel

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

East Metropolitan Health Service, Australia

Collaborateurs

Harry Perkins Institute of Medical Research

Les enquêteurs

  • Chaise d'étude: Peter Lau, MBBS, Harry Perkins Institute for Medical Research
  • Chercheur principal: Ben Carnley, MBBS, Royal Perth Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 juillet 2029

Achèvement de l'étude (Estimé)

1 avril 2032

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

11 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • U1111-1315-9162
  • HREC/114234/PMCC (Autre identifiant: Peter MacCallum Cancer Centre Human Research Ethics Committee)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

Data will be published in a de-identified format. Sharing individual participant data will be considered on a case by case basis.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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