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Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma

A Phase I Study of Adoptive Tumor-infiltrating Lymphocyte Transfer in Combination With Nivolumab in Patients With Advanced Melanoma

NCT04165967•University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

This study is to investigate safety and feasibility of a combination therapy of a tumor infiltrating lymphocytes (TIL) transfer with anti-programmed cell death protein (PD)-1 therapy in patients with metastatic melanoma that failed immunotherapy.Tumor-infiltrating lymphocytes will be expanded from resected melanoma samples from the patient and expanded TILs will be transferred to the patient after non-myeloablative chemotherapy with cyclophosphamide and fludarabine. TIL transfer will be combined with low dose Interleukin (IL)-2 and nivolumab anti-PD-1 treatment. The study uses a personalized Investigational Medicinal Product (IMP), i.e. TIL product and in combination with IL-2 treatment and nivolumab.

Detailed Description

Adoptive cell therapy has been previously shown to be an effective treatment option for patients with melanoma. Due to an immunosuppressive microenvironment, not all patients respond to this therapy. In this trial, the immune suppressive microenvironment will be targeted by adding a PD-1 blocking antibody in combination with a TIL Transfer. Tumor-infiltrating lymphocytes will be expanded from resected melanoma samples from the patient and expanded TILs will be transferred to the patient after non-myeloablative chemotherapy with cyclophosphamide and fludarabine. TIL transfer will be combined with low dose IL-2 and nivolumab anti-PD-1 treatment. The study uses a personalized IMP, i.e. TIL product and in combination with IL-2 treatment and nivolumab.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed unresectable or metastatic melanoma
•At least 1 PD-1 targeted immunotherapy and BRAF inhibition in case of BRAF mutated melanoma
•Resectable tumor mass and measurable disease by CT or MRI per RECIST 1.1 criteria (in addition to the resected lesion)
•World Health Organization (WHO) clinical performance Status (ECOG) 0-1
•Adequate organ function
•Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for five months after receiving the last dose of nivolumab for women and seven months for men
•Patients must be able to understand and sign the Informed consent document
•Hematology: Absolute neutrophil count greater than 1.5 x 109/L without support of filgrastim. Platelet count greater than 100 x 109/L. Hemoglobin greater than 5 mmol/L, or 80 g/L.
•Chemistry: Serum alanine aminotransferase (ALAT)/ aspartate transaminase (ASAT) less than 3 times the upper limit of normal, unless patients have liver metastases (\< 5 times ULN). Serum creatinine clearance 50 ml/min or higher. Total Bilirubin less than or equal to 20 micromol/L, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 50 micromol/L. Lactate dehydrogenase (LDH) ≤ 2x ULN
•Serology: Seronegative for HIV antibody. Seronegative for hepatitis B antigen, and hepatitis C antibody. Seronegative for syphilis.

Exclusion Criteria

•Life expectancy of less than three months
•Patients with metastatic ocular/ mucosal or other non-cutaneous melanoma.
•Requirement for immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to randomization
•Uncontrolled central nervous system (CNS) metastases. Controlled CNS metastases must be for at least 4 weeks stable.
•Documented Forced expiratory volume at one second (FEV1) less than or equal to 50% predicted for patients with:
•A prolonged history of cigarette smoking (greater than 20 pack/year within the past 2 years)
•Symptoms of respiratory distress
•All patients' toxicities due to prior non-systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less.
•Women who are pregnant or breastfeeding, because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
•Any active systemic infections, coagulation disorders or other active major medical illnesses.
+2 more criteria

Locations (1)

Division of Medical Oncology and Cancer Immunology, University Hospital Basel

Basel, Switzerland

Key Dates

Start Date

September 17, 2020

Primary Completion Date

March 30, 2023

Completion Date

March 30, 2023

Last Updated

April 10, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Melanoma

Interventions

Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma

Inclusion Criteria

Exclusion Criteria

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