Evidence map›Paper›PMID 21498393›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy.

Steven A Rosenberg, James C Yang, Richard M Sherry, Udai S Kammula, Marybeth S Hughes, Giao Q Phan, Deborah E Citrin, Nicholas P Restifo, Paul F Robbins, John R Wunderlich and 5 more

7 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 1,241 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,241citing papers in PubMed, 2 pooled it
59.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01585428 phase2completednot on this mapstarted 2012, after this paper: background citation

A Phase II Study of Lymphodepletion Followed by Autologous Tumor-Infiltrating Lymphocytes and High-Dose Aldesleukin for Human Papillomavirus-Associated Cancers

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2012 to 2016Enrolled29ConditionsCervical Cancer, Oropharyngeal Cancer, Vaginal Cancer, Anal CancerArmsFludarabine, Cyclophosphamide, Young TIL, Aldesleukin
NCT01814046 phase2terminatednot on this mapstarted 2013, after this paper: background citation

Phase II Study in Patients With Metastatic Ocular Melanoma Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Autologous Tumor-Infiltrating Lymphocytes With or Without High Dose Aldesleukin

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2017Enrolled24ConditionsMetastatic Ocular Melanoma, Metastatic Uveal MelanomaArmsAldesleukin, Cyclophosphamide, Fludarabine, Young Tumor Infiltrating Lymphocytes (TIL)
NCT01967823 phase2completednot on this mapstarted 2013, after this paper: background citation

Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2020Enrolled11ConditionsMelanoma, Meningioma, Breast Cancer, Non-Small Cell Lung CancerArmsAnti-NY ESO-1 mTCR PBL, Cyclophosphamide, Fludarabine, Aldesleukin
NCT02062359 phase2terminatednot on this mapstarted 2014, after this paper: background citation

Phase II Study of CD62L+-Derived T Lymphocytes Transduced With a T Cell Receptor Recognizing the NY-ESO-1 Antigen and Aldesleukin Following Lymphodepletion in Patients With NY-ESO-1 Expressing Melanoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2014 to 2016Enrolled2ConditionsMetastatic Cancer, Metastatic MelanomaArmsAnti-NY ESO-1 T cell receptor (TCR) cluster of differentiation 62L (CD62L)+ cells, Aldesleukin, Cyclophosphamide, Fludarabine
NCT02489266 phase1withdrawnnot on this mapstarted 2015, after this paper: background citation

A Phase I Trial for the Evaluation of the In Vivo Persistence of Adoptively-transferred Tumor-Infiltrating Lymphocytes Cultured With a Pharmacologic Inhibitor of AKT in Patients With Metastatic Melanoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2015 to 2016Enrolled0ConditionsMetastatic MelanomaArmsAKTi-treated TIL, Cyclophosphamide, Fludarabine, Aldesleukin
NCT02621021 phase2recruitingnot on this mapstarted 2015, after this paper: background citation

A Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2015 to 2029Enrolled53ConditionsMelanomaArmsyoung TIL, Pembrolizumab, Aldesleukin, Fludarabine, Cyclophosphamide
NCT02661685 phase1completednot on this mapstarted 2016, after this paper: background citation

An Immunotherapy for Metastatic Cancer Patients by Adoptive Transfer of Autologous IKDC-like Cells - Phase 1 Clinical Trial

TypeinterventionalSponsorNational Defense Medical Center, TaiwanRan2016 to 2019Enrolled6ConditionsNeoplasm MetastasisArmsautologous IKDC-like cells
3 · Its place in the literature

Who cites it

1,241 citing papers in PubMed, 2 syntheses or guidelines pooled it, 2,095 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. FDA Approval Summary: Lifileucel for Unresectable or Metastatic Melanoma Previously Treated with an Anti-PD-1-Based Immunotherapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Adoptive cell therapy in lung cancer: progress, challenges, and prospects.Chinese medical journal pulmonary and critical care medicine · 2026
    Review
  16. Review
  17. Review
  18. Cell surface ADGRG1 and CD86 expression identifies antitumor CD4Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  19. Review
  20. Review

1,181 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Steven A RosenbergSurgery Branch, National Cancer Institute, NIH, Bethesda, Maryland, USA. sar@nih.gov
James C Yang
Richard M Sherry
Udai S Kammula
Marybeth S Hughes
Giao Q Phan
Deborah E Citrin
Nicholas P Restifo
Paul F Robbins
John R Wunderlich
Kathleen E Morton
Carolyn M Laurencot
Seth M Steinberg
Donald E White
Mark E Dudley
National Cancer Institute · US

Funding

Adoptive Cell Transfer Immunotherapy of CancerZIABC010984 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2025
$56.8M
Building on the success of the adoptive immunotherapy of cancerZIABC010763 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2020
$25.0M
Surgery Branch Cell Prep CoreZICBC010905 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HALAS, HYUNMI · 2009 to 2025
$23.9M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Cell Production Facility CoreZICBC011020 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI DUDLEY, MARK · 2009 to 2013
$6.5M
THE IMMUNOTHERAPY OF ANIMAL AND HUMAN CANCERZ01SC003811 · SC · CLINICAL SCIENCES · PI ROSENBERG, STEVEN A · 1996 to 2007
$3.2M
Intramural NIH HHS Z01 SC003811
6 · The paper itself

Abstract

purposeMost treatments for patients with metastatic melanoma have a low rate of complete regression and thus overall survival in these patients is poor. We investigated the ability of adoptive cell transfer utilizing autologous tumor-infiltrating lymphocytes (TIL) to mediate durable complete regressions in heavily pretreated patients with metastatic melanoma. EXPERIMENTAL

designNinety-three patients with measurable metastatic melanoma were treated with the adoptive transfer of autologous TILs administered in conjunction with interleukin-2 following a lymphodepleting preparative regimen on three sequential clinical trials. Ninety-five percent of these patients had progressive disease following a prior systemic treatment. Median potential follow-up was 62 months.

resultsObjective response rates by Response Evaluation Criteria in Solid Tumors (RECIST) in the 3 trials using lymphodepleting preparative regimens (chemotherapy alone or with 2 or 12 Gy irradiation) were 49%, 52%, and 72%, respectively. Twenty of the 93 patients (22%) achieved a complete tumor regression, and 19 have ongoing complete regressions beyond 3 years. The actuarial 3- and 5-year survival rates for the entire group were 36% and 29%, respectively, but for the 20 complete responders were 100% and 93%. The likelihood of achieving a complete response was similar regardless of prior therapy. Factors associated with objective response included longer telomeres of the infused cells, the number of CD8(+)CD27(+) cells infused, and the persistence of the infused cells in the circulation at 1 month (all P(2) < 0.001).

conclusionsCell transfer therapy with autologous TILs can mediate durable complete responses in patients with metastatic melanoma and has similar efficacy irrespective of prior treatment. Clin Cancer Res; 17(13); 4550-7. ©2011 AACR.

Indexed as

Immunotherapy, AdoptiveAdolescentAdultAgedCombined Modality TherapyFemaleHumansLymphocyte CountLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedSurvival AnalysisTelomereTreatment OutcomeYoung Adult

Identifiers

PMID21498393
PMCPMC3131487
OpenAlexW2132923173

What OpenQuestion holds

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Registered trials

and 1 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.