NCT03645928Phase 2Terminated

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Study sponsor: Iovance Biotherapeutics, Inc. · IOVA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-02-20Actual

Enrollment · participants225Actual

Source updated2026-05-15Last update listed in the registry record

Version history

Changes to this trial

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Posted 2026-05-15 · 6 fields changed

Primary outcomes · main study measures

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measure: Objective Response Rate; measure: Safety Profile Measured by Grade ≥3 TEAEs; measure: To evaluate the feasibility of producing lifileucel using tumor samples obtained before (Cohort 3D) or during (Cohort 3E) frontline platinum doublet chemotherapy and pembrolizumab in patients with Stage IV NSCLC

+ Updated value

measure: Objective Response Rate; measure: Safety Profile Measured by Grade ≥3 TEAEs; measure: Percentage of patients for whom lifileucel is successfully manufactured and meets release specification

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Participant count type

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Estimated

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Actual

Enrollment · participant count

Recorded edit

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count: 245; type: ESTIMATED

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count: 225; type: ACTUAL

Completion date type

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Estimated

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Actual

Primary completion date

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2029-08-09

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2026-02-20

Recruitment status

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Recruiting

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Terminated

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Study details

Conditions studied

Metastatic Melanoma; Squamous Cell Carcinoma of the Head and Neck; Non-small Cell Lung Cancer

Treatments or interventions studied

LifileucelBiologicalAlso known as LN-144, TIL, autologous tumor-infiltrating lymphocytes
LN-145BiologicalAlso known as TIL, autologous tumor infiltrating lymphocytes
PembrolizumabDrugAlso known as Keytruda
LN-145-S1BiologicalAlso known as TIL, autologous tumor-infiltrating lymphocytes, PD-1-selected TIL
IpilimumabDrugAlso known as Yervoy
NivolumabDrugAlso known as Opdivo
Nivolumab-relatlimabDrugAlso known as Opdualag
CisplatinDrug
CarboplatinDrug
PaclitaxelDrug
Nab paclitaxelDrug
PemetrexedDrug

Primary outcomes · main study measures

Read the study measures

measure: Objective Response Rate; description: To evaluate the efficacy of autologous TIL in combination with ICIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients as determined by objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Investigator; timeFrame: Up to 60 months; measure: Safety Profile Measured by Grade ≥3 TEAEs; description: To characterize the safety profile of autologous TIL in combination with ICIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs); timeFrame: Up to 60 months; measure: Percentage of patients for whom lifileucel is successfully manufactured and meets release specification; description: To evaluate the feasibility of producing lifileucel using tumor samples obtained before (Cohort 3D) or during (Cohort 3E) frontline platinum doublet chemotherapy and pembrolizumab in patients with Stage IV NSCLC; timeFrame: Up to 60 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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