Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers (NCT03935893) | Clinical Trial Compass
RecruitingPhase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers
United States240 participantsStarted 2019-12-03
Plain-language summary
This is a Phase 2 study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options by using the objective response rate (ORR).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
Measurable locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options
Patients with locally advanced disease should be unresectable by conventional surgical approaches.
Patients with distant metastatic spread must have previously received approved first-line systemic therapies if they are eligible to receive these treatments.
Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy.
Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
Greater than or equal to 18 years of age and less than or equal to age 75
Able to understand and sign the Informed Consent Document
Clinical performance status of ECOG 0 or 1
Life expectancy of greater than three months
Patients of both genders who are of chi…