OncoMatch/Clinical Trials/NCT03645928
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
Is NCT03645928 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for metastatic melanoma.
Treatment: Lifileucel · LN-145 · Pembrolizumab · LN-145-S1 · Ipilimumab · Nivolumab · Nivolumab-relatlimab · Cisplatin · Carboplatin · Paclitaxel · Nab-Paclitaxel · Pemetrexed — A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Head and Neck Squamous Cell Carcinoma
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: ROS1 wild-type
Disease stage
Required: Stage IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: PD-1 blocking antibody — systemic therapy
must have previously received systemic therapy with a PD-1 blocking antibody (Cohorts 1B or 1C)
Must have received: immune checkpoint inhibitor — systemic therapy
NSCLC patients in Cohort 3B must have previously received systemic therapy with any ICI (except for those patients with known oncogene driver mutations that are sensitive to targeted therapies) as part of 1 - 3 prior lines of therapy
Must have received: immune checkpoint inhibitor — systemic therapy
NSCLC patients in Cohort 3C must have previously received 1 line of ICI monotherapy. No other systemic therapy for metastatic disease is allowed.
Cannot have received: immune checkpoint inhibitor
Exception: adjuvant/neoadjuvant ICI(s) for non-metastatic disease with immune-related AE(s) requiring systemic steroid treatment or discontinuation of immune checkpoint inhibitor therapy (Cohorts 1D, 3D, or 3E)
Patients in Cohorts 1D, 3D, or 3E who previously received adjuvant or neoadjuvant ICI(s) for non-metastatic disease and had an immune-related AE(s) requiring systemic steroid treatment or discontinuation of immune checkpoint inhibitor therapy
Lab requirements
Cardiac function
LVEF < 45% or NYHA Class II or higher excluded; cardiac stress test demonstrating any irreversible wall movement abnormality in patients ≥60 years or with cardiac history
Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association Class II or higher. A cardiac stress test demonstrating any irreversible wall movement abnormality in any patients ≥60 years of age or in patients who have a history of ischemic heart disease, cardiac chest pain, or clinically significant atrial and/or ventricular arrhythmias.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Diego · La Jolla, California
- University of Southern California · Los Angeles, California
- University of California, Los Angeles · Los Angeles, California
- University of Colorado · Denver, Colorado
- Yale University · New Haven, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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