NCT03083873Phase 2Completed

Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck

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 completion2022-08-08Actual

Enrollment · participants64Actual

Source updated2023-10-12Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Squamous Cell Carcinoma of the Head and Neck

Treatments or interventions studied

LN-145BiologicalAlso known as TIL, autologous tumor infiltrating lymphocytes
LN-145-S1BiologicalAlso known as TIL, autologous tumor infiltrating lymphocytes

Primary outcomes · main study measures

Read the study measures

measure: Objective Response Rate; description: The percentage of patients who have a confirmed complete response or partial response as assessed by the investigator per RECIST v1.1. Objective response rate (ORR) will be defined as the percentage of the patients with a confirmed complete or partial response (CR or PR),by MRI or CT scan as per RECIST 1.1 criteria. Complete response (CR), Disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size(\<10mm short axis). No new lesions. Partial response (PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion(s) and/or maintenance above the normal limits (Non-CR/Non-PD). No new lesions.; timeFrame: Up to 24 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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