PERTIL-01: A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients with Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma
A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients with Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma
East Metropolitan Health Service
10 participants
Apr 1, 2026
Interventional
Conditions
Summary
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 adult patients with unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting. Who is it for? This study may be suitable for adults aged between 18 to 70 years of age who have unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting. Participants need to have a reasonable general health (ECOG 0–1) and a life expectancy greater than 6 months. Study details: All participants will receive the investigational treatment Perkileucel. To create this therapy, participants need to undergo surgical excision of the 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.
Eligibility
Inclusion Criteria6
- Adult patients between 18 years to 70 years of age.
- ECOG 0-1 (Appendix A: Eastern Cooperative Oncology Group Performance Status Scale) with an estimated life expectancy of > 6 months
- 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.
- Metastatic melanoma with at least 1 surgically accessible metastatic lesion (or aggregate lesions) with an estimated minimum diameter of = 1.5 cm
- Measurable disease per RECIST 1.1 criteria (in addition to the resected lesion).
- 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 Criteria7
- Life expectancy of less than 3 months.
- Metastatic uveal melanoma.
- 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, or less, of prednisone or another steroid equivalent dose are acceptable.
- 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 at least 60 days
- Participants with previously known asymptomatic brain metastases who do not clinically require treatment may be enrolled.
- More than three melanoma brain metastases or evidence of leptomeningeal disease
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Interventions
Perkileucel is an autologous Tumour Infiltrating Lymphocyte (TIL) Adoptive Cell Transfer (ACT). A surgically excised tumour sample of the melanoma tissue will be collected, soon after consent, to manufacture the autologous melanoma-reactive TILs Five days prior to infusion of the Perkileucel (Day -5), all patients will undergo lymphodepletive chemotherapy with fludarabine, given intravenously at 25mg/m^2/day and cyclophosphamide, given intravenously at 60mg/kg/day for 2 consecutive days, Followed by fludarabine, given intravenously at 25mg/m^2/day for another 3 consecutive days. Perkileucel will be given as a single intravenous infusion of 1x10^9 TIL up to a maximum of 2x10^11 TIL on Day 0. Up to 6 infusions of high-dose Interleukin-2, also known as aldesleukin, will be received after the TILs infusion. The Interleukin-2 infusions will commence between 3 - 24 hours after the Perkileucel infusion and will be administered every 8-12 hours. Doses may be skipped depending on patient tolerance. Patients will be admitted to hospital from Day -5 and total inpatient stay from chemotherapy to recovery after IL-2 infusions will be approximately 15 days. Regular safety monitoring of vital signs, laboratory tests and adverse events will occur regularly throughout the trial.
Locations(1)
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ACTRN12626000394347