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Clinical Trials/EUCTR2017-000760-15-IT
EUCTR2017-000760-15-IT
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

IOVANCE BIOTECHNOLOGIES, INC0 sites85 target enrollmentNovember 4, 2020
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DrugsFludarabine PhosphateCyclophosphamideProleukinFludarabine Phosphate for injection

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
IOVANCE BIOTECHNOLOGIES, INC
Enrollment
85
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 4, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IOVANCE BIOTECHNOLOGIES, INC

Eligibility Criteria

Inclusion Criteria

  • •a. Patients with unresectable or metastatic melanoma (Stage IIIc or
  • •Stage IV) who progressed following \= 1 lines of prior systemic
  • •therapy, including immune checkpoint inhibitor (eg, anti\-PD\-1\), and
  • •if BRAF mutation\-positive, after BRAF inhibitor systemic therapy.
  • •Patients must have no other therapy options that are expected to have
  • •significant benefit in the opinion of the Investigator and must have:
  • •At least 1 measurable target lesion, as defined by RECIST 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 disease progression in the lesion

Exclusion Criteria

  • •a. Patients with melanoma of uveal/ocular origin
  • •b. Patients who have received an organ allograft or prior cell transfer
  • •therapy that included a nonmyeloablative or myeloablative
  • •chemotherapy regimen (not applicable for patients in the retreatment
  • •c. 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 after discussion with the Medical
  • •Monitor, and must be stable for \= 2 weeks prior to the start of
  • •d. Patients who are pregnant or breastfeeding

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
A study to find out if an investigational product, called LN-144 (alsocalled tumour infiltrating lymphocytes) is safe and beneficial in thetreatment of patients with metastatic melanomaMetastatic melanomaMedDRA version: 20.0Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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A study to find out if an investigational product, called LN-144 (also called tumour infiltrating lymphocytes) is safe and beneficial in the treatment of patients with metastatic melanomaMetastatic melanomaMedDRA version: 20.0 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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A study to find out if an investigational product, called LN-144 (alsocalled tumour infiltrating lymphocytes) is safe and beneficial in thetreatment of patients with metastatic melanoma
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Phase 1
A study to find out if an investigational product, called LN-144 (alsocalled tumour infiltrating lymphocytes) is safe and beneficial in thetreatment of patients with metastatic melanomaMetastatic melanomaMedDRA 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]
EUCTR2017-000760-15-DEIovance Biotherapeutics, Inc.164