EUCTR2017-000760-15-FR
Active, not recruiting
Phase 1
A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN 144) for Treatment of Patients with Metastatic Melanoma - Study of LN-144 in the Treatment of Patients with Metastatic Melanoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic melanoma
- Sponsor
- Iovance Biotherapeutics, Inc.
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a. Patients with unresectable metastatic melanoma (Stage IIIc or
- •Stage IV) who progressed following \=1 line of prior systemic therapy,
- •including immune checkpoint inhibitor (e.g., anti\-PD\-1\), and if BRAF
- •mutation\-positive, after BRAF inhibitor systemic therapy
- •\- At least one measurable target lesion as defined by RECIST version
- •1\.1\. Lesions in previously irradiated areas should not be selected as
- •target lesion, unless treatment was \= 3 months prior, and there has
- •been demonstrated progression in the lesion
- •\- At least one resectable lesion to generate TILs of a minimum 1\.5 cm
- •in diameter post\-resection
Exclusion Criteria
- •a. Patients with melanoma of uveal/ocular origin
- •b. Patients who have received prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen (not applicable for patients in the retreatment Cohort 3\)
- •c. Patients with symptomatic and/or untreated brain metastases (of any size and any number)
- •\- Patients with definitively treated brain metastases, will be considered for enrollment after discussion with Medical Monitor, and must be stable for 2\-4 weeks prior to the start of treatment nonmyeloablative lymphodepletion)
- •d. Patients who are pregnant or breastfeeding
- •e. Patients who are on a systemic steroid therapy at a dose of \> 10 mg of prednisone or equivalent per day
- •\- A short course of higher dose steroid therapy is allowed in cases of
- •exacerbation of known disease or for treatments of new acute symptoms
- •f. Patients who have active medical illness(es) that in the opinion of the Investigator would pose increased risk for study participation, such as systemic infections requiring antibiotics, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system
- •g. Patients who have any form of primary immunodeficiency (such as
Outcomes
Primary Outcomes
Not specified
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