A Phase 2, Multicenter Study to Assess the Efficacy and Safety ofAutologous Tumor Infiltrating Lymphocytes (LN 144) for Treatment ofPatients with Metastatic Melanoma - Study of LN-144 in the Treatment of Patients with Metastatic Melanoma

Iovance Biotherapeutics, Inc.0 sites164 target enrollmentSeptember 14, 2017

ConditionsMetastatic melanoma MedDRA version: 21.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsCyclophosphamide Proleukin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic melanoma
Sponsor: Iovance Biotherapeutics, Inc.
Enrollment: 164
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 14, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Iovance Biotherapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•a. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV)
•b. Patients must have progressed following \= 1 prior systemic therapy including a PD\-1 blocking antibody; and if BRAF V600 mutation\-positive, a BRAF inhibitor or BRAF inhibitor in combination with MEK inhibitor
•c. Prior to study Enrollment, documentation of radiological disease progression after the most recent therapy
•d. At least one measurable target lesion, as defined by RECIST v1\.1
•Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was \= 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion
•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, but only as a non\-target lesion
•e. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1\.5 cm in diameter post\-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is \= 3 days)
•f. Patients must be \= 18 years of age at the time of consent. Enrollment of patients \> 70 years of age may be allowed after consultation with the Medical Monitor
•g. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 2\) and an estimated life expectancy of \= 3 months
•h. In the opinion of the Investigator, patients must be able to complete all study required procedures

Exclusion Criteria

•a. Patients who have been shown to be BRAF mutation positive (V600\), but have not received prior systemic therapy with a BRAF inhibitor alone or a BRAF inhibitor in combination with a MEK inhibitor
•b.Patients who have received an organ allograft or prior cell transfer therapy
•c.Patients with melanoma of uveal/ocular origin
•d.Patients who have a history of hypersensitivity to any component or excipient of LN\-144 or other study drugs:
•NMA\-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)
•Antibiotics (ABX) of the aminoglycoside group (ie, streptomycin, gentamicin); except those who are skin\-test negative for gentamicin hypersensitivity
•Any component of the LN\-144 infusion product formulation including DMSO, HSA, IL\-2, and dextran\-40
•e.Patients with symptomatic and/or untreated brain metastases (of any size and any number)
•Patients with definitively treated brain metastases may be considered for Enrollment, and must be stable for \= 14 days prior to beginning the NMA\-LD preconditioning regimen
•f.Patients who are on chronic systemic steroid therapy for any reason