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NCT02375984: TIL

A Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanomas

Terminated Phase 2 Results posted Last updated 22 September 2021
What this trial tests

Phase 2 trial testing Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanoma in 1 participant. Terminated before completion.

Timeline
16 March 2016
Primary endpoint
1 June 2017
1 June 2017

Quick facts

Lead sponsorSaint John's Cancer Institute
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1
Start date16 March 2016
Primary completion1 June 2017
Estimated completion1 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Saint John's Cancer Institute

Who can join

18 and older, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Response Primary · 12 weeks, or until development of new metastases or recurrence

At the end of 12 week follow up, the proportion of patients that showed clinical response (CR) determined by the disappearance of all target lesions, or partial response (PR) will be calculated. The patient is determined to have partial response as if 30% reduction in the sum of the longest diameter (SLD) of target lesions are shown from the baseline sum LD.

GroupValue95% CI
Tumor Infiltrating Lymphocytes (TIL)0
Tumor Infiltrating Lymphocytes (TIL)0
Tumor Infiltrating Lymphocytes (TIL)1

Adverse events — posted to ClinicalTrials.gov

Time frame: Single patient treated, data collected from baseline up to 72 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tumor Infiltrating Lymphocytes (TIL)
Serious: 0/1 (0%)
Deaths: 1/1
Other adverse events (23 terms — click to expand)

ReactionSystemTumor Infiltrating Lymphoc…
headacheNervous system disorders
constipationGastrointestinal disorders
blurred visionEye disorders
diarrheaGastrointestinal disorders
alopeciaSkin and subcutaneous tissue disorders
anorexiaMetabolism and nutrition disorders
fatigueGeneral disorders
hiccupsRespiratory, thoracic and mediastinal disorders
nauseaGastrointestinal disorders
back painMusculoskeletal and connective tissue disorders
facial painGeneral disorders
abdominal painGastrointestinal disorders
Alanine aminotransferase increasedInvestigations
Alkaline phosphatase increasedInvestigations
Lymphocyte count decreasedInvestigations
neutrophil count decreasedInvestigations
Platelet count decreasedInvestigations
White blood cell decreasedInvestigations
Aspartate aminotransferase increasedInvestigations
Rash maculo-papularSkin and subcutaneous tissue disorders
agitationPsychiatric disorders
Other, sunburnSkin and subcutaneous tissue disorders
Mucositis oralGastrointestinal disorders

Data from ClinicalTrials.gov NCT02375984 adverse events section.

Sponsor's own description

The purpose of this protocol is to determine whether autologous TIL infused in conjunction with systemic high-dose IL-2 after non-myeloablative chemotherapy with cyclophosphamide and fludarabine can cause consistent and durable objective responses in patients who have metastatic melanoma at the John Wayne Cancer Institute (JWCI).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Trial Watch: Adoptive cell transfer for oncological indications.
    Aranda F, Buqué A, Bloy N, Castoldi F, et al · · 2015 · cited 28× · PMID 26451319 · DOI 10.1080/2162402x.2015.1046673
  2. Current Situation and Prospect of Adoptive Cellular Immunotherapy for Malignancies.
    Zhao D, Zhu D, Cai F, Jiang M, et al · · 2023 · cited 12× · PMID 38037341 · DOI 10.1177/15330338231204198

Verify or expand the search:

Other trials of Tumor Infiltrating Lymphocytes (TIL)

Trials testing the same drug.

Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

Other Saint John's Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02375984.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing