Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma
An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL; LN-144), for Patients with Unresectable or Metastatic Melanoma
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Grofsik, Kiera; Frankos, Marie; Djuro, Victor; Walton, Sherri
Trial Phone: 321.841.9821 ; 321.841.6626 ; 321.841.7303 ; 321.841.7477 ; 321.841.1907
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IRB No: 22.089.04
Protocol Abbrev: IOV-EAP-401
Principal Investigator: Sajeve Samuel Thomas, MD
Age Group: Adult
Secondary Protocol No: IOV-EAP-401
Treatment: Lifileucel: Autologous TIL derived from the patient’s tumor
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05398640
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Objective
To provide access to lifileucel therapy (adoptive T cell therapy) for patients with unresectable or metastatic melanoma
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Key Eligibility
Patients must meet all of the following inclusion criteria to be eligible for this protocol:
1. Patients with unresectable or metastatic cutaneous, mucosal and acral melanoma (Stages IIIC, IIID or IV using AJCC 8th Edition)
2. Patients must have progressed on or did not achieve a response for at least 6 months or were intolerant due to toxicity following 1-4 prior lines of systemic therapy including a programmed cell death protein-1 (PD-1) or ligand-1 (PD-L1) blocking antibody and a BRAF inhibitor with or without a MEK inhibitor if BRAF V600 mutation positive, unless BRAF/MEK inhibition is not required by the Treating Physician’s evaluation. Additional prior lines of therapy may be considered through consultation between Treating Physician and Sponsor.
3. Patients may have received prior adjuvant PD-1/PD-L1 blocking antibody if they recurred within 6 months of discontinuation of therapy or while on therapy
4. At least one measurable target lesion, as defined by RECIST v1.1; if a lesion is partially resected to generate TIL and remains visible on the Baseline scan after surgery, then the partially resected lesion can be used for RECIST v1.1 response assessment by radiographic imaging and follow-up
5. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
6. Patients must be ≥ 18 years of age at the time of consent.
7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months.
8. Patients must have the following hematologic parameters:
• Absolute neutrophil count (ANC) ≥ 1000/mm3
• Hemoglobin (Hb) ≥ 9.0 g/dL
• Platelet ≥ 100,000/mm3
9. Patients must have adequate organ function:
• Serum alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN
• Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula
• Total bilirubin ≤ 2 mg/dL
• Patients with Gilbert’s syndrome must have a total bilirubin ≤ 3 mg/dL
10. Palliative radiation therapy is permitted so long as it does not involve lesions selected for TIL generation. Lesions in previously irradiated areas should not be selected as target lesions unless there has been documented progression in those lesions and irradiation has not occurred within the past 3 months. In addition, irradiated lesions may not be selected as non-target lesions if irradiation has occurred within the past 2 weeks.
11. Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the protocol and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy.
12. Patients (or legally authorized representative) must have the ability to understand the requirements of the protocol, have provided written informed consent as evidenced by signature on an ICF and agree to abide by protocol restrictions and assessments.
13. In the Treating Physician’s opinion, there is no comparable or satisfactory alternative therapy to treat the patient’s advanced melanoma. Patients who were intolerant to prior therapies should have their toxicities resolved to ≤ Grade 1 per CTCAE v5.0 or controlled by medication except for alopecia and vitiligo. There should also be no evidence of ongoing colitis by sigmoidoscopy if patient has clinical symptoms or signs of colitis.
