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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 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

10

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Biologisk: 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.
Läkemedel: 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.
Andra namn:
  • Flu-Cy
Läkemedel: 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.
Andra namn:
  • Interleukin-2

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Median Progression Free Survival
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

East Metropolitan Health Service, Australia

Samarbetspartners

Harry Perkins Institute of Medical Research

Utredare

  • Studiestol: Peter Lau, MBBS, Harry Perkins Institute for Medical Research
  • Huvudutredare: Ben Carnley, MBBS, Royal Perth Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 juli 2029

Avslutad studie (Beräknad)

1 april 2032

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

11 juni 2026

Första postat (Faktisk)

16 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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