Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016
Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients With Metastatic Melanoma.
Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01319565 (A Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Short-Term Cultured Tumor-Infiltrating Lymphocytes Plus IL-2 Following Either a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Alone or in Conjunction With 12Gy Total Body Irradiation), which is not on this map. Cited by 259 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
259citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.
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.
A Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Short-Term Cultured Tumor-Infiltrating Lymphocytes Plus IL-2 Following Either a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI)
Who cites it
259 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The cost-effectiveness of tumour-infiltrating lymphocyte cell therapy for advanced melanoma: a systematic review.BMC cancer · 2026Pooled it
- Current status and challenges of immunotherapy in ALK rearranged NSCLC.Frontiers in oncology · 2022Pooled it
- Neoantigen-specific tumor-infiltrating lymphocytes in gastrointestinal cancers: a phase 2 trial.Nature medicine · 2025Trial
- Reduced dose fludarabine and cyclophosphamide lymphodepletion before tumor-infiltrating lymphocyte therapy in melanoma.Future oncology (London, England) · 2025Trial
- Rapamycin-resistant polyclonal Th1/Tc1 cell therapy (RAPA-201) safely induces disease remissions in relapsed, refractory multiple myeloma.Journal for immunotherapy of cancer · 2025Trial
- Lifileucel, an Autologous Tumor-Infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-Small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors.Cancer discovery · 2024Trial
- Cost-effectiveness of treating advanced melanoma with tumor-infiltrating lymphocytes based on an international randomized phase 3 clinical trial.Journal for immunotherapy of cancer · 2024Trial
- Combination Nivolumab, CD137 Agonism, and Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes for Patients with Metastatic Melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- Randomized phase II trial of lymphodepletion plus adoptive cell transfer of tumor-infiltrating lymphocytes, with or without dendritic cell vaccination, in patients with metastatic melanoma.Journal for immunotherapy of cancer · 2021Trial
- Head-to-head comparison of in-house produced CD19 CAR-T cell in ALL and NHL patients.Journal for immunotherapy of cancer · 2020Trial
- First-in-human trial of rhIL-15 and haploidentical natural killer cell therapy for advanced acute myeloid leukemia.Blood advances · 2019Trial
- Phase II clinical trial of adoptive cell therapy for patients with metastatic melanoma with autologous tumor-infiltrating lymphocytes and low-dose interleukin-2.Cancer immunology, immunotherapy : CII · 2019Trial
- Salvage Metastasectomy After Adoptive Cell Transfer for Melanoma: Long-Term Updates.Annals of surgical oncology · 2026Article
- Combining Radiation Therapy and Tumor-Infiltrating Lymphocyte Therapy: Biological Rationale, Clinical Synergies, and Future Directions.Current oncology (Toronto, Ont.) · 2026Review
- Tumor-infiltrating lymphocyte (TIL) therapy: Historical context, clinical applications, and future directions.Cancer · 2026Review
- Tumor irradiation promotes antigen dressing of dendritic cells to enhance CAR T cell persistence and efficacy in lung metastases.Nature cancer · 2026Article
- Real-World Tumor-Infiltrating Lymphocyte Therapy for Metastatic Melanoma: Treatment Delivery, Immune Reconstitution, and Cardiac Monitoring During High-Dose IL-2.Current oncology (Toronto, Ont.) · 2026Article
- Breathing new life into T-cell receptor-engineered T-cell therapy in solid tumors: enhancing strategies to expand the universality of precision therapy.Experimental hematology & oncology · 2026Review
- CAR T cells for pediatric CNS tumors: Clinical experience and reverse translational opportunities.Molecular therapy. Oncology · 2026Review
- Tumour-infiltrating lymphocyte therapy in melanoma: ready for prime time?British journal of cancer · 2026Review
199 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
25 authors.
Stephanie L GoffStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA. stephanie.goff@nih.gov.
Mark E DudleyStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Deborah E CitrinStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Robert P SomervilleStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
John R WunderlichStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
David N DanforthStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Daniel A ZlottStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
James C YangStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Richard M SherryStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Udai S KammulaStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Christopher A KlebanoffStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Marybeth S HughesStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Nicholas P RestifoStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Michelle M LanghanStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Thomas E SheltonStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Lily LuStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Mei Li M KwongStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Sadia IlyasStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Nicholas D KlemenStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Eden C PayabyabStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Kathleen E MortonStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Mary Ann ToomeyStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Seth M SteinbergStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Donald E WhiteStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Steven A RosenbergStephanie L. Goff, Deborah E. Citrin, Robert P. Somerville, John R. Wunderlich, David N. Danforth, James C. Yang, Richard M. Sherry, Udai S. Kammula, Christopher A. Klebanoff, Marybeth S. Hughes, Nicholas P. Restifo, Michelle M. Langhan, Thomas E. Shelton, Lily Lu, Mei Li M. Kwong, Sadia Ilyas, Nicholas D. Klemen, Eden C. Payabyab, Kathleen E. Morton, Mary Ann Toomey, Seth M. Steinberg, Donald E. White, and Steven A. Rosenberg, National Cancer Institute, National Institutes of Health; Daniel A. Zlott, Clinical Center, National Institutes of Health, Bethesda, MD; and Mark E. Dudley, Novartis Institutes for BioMedical Research, Cambridge, MA.
Funding
Building on the success of the adoptive immunotherapy of cancerZIABC010763 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2020
$25.0MCell Production Core FacilityZICBC011569 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HALAS, HYUNMI · 2014 to 2025
$17.4MAbstract
purposeAdoptive cell transfer, the infusion of large numbers of activated autologous lymphocytes, can mediate objective tumor regression in a majority of patients with metastatic melanoma (52 of 93; 56%). Addition and intensification of total body irradiation (TBI) to the preparative lymphodepleting chemotherapy regimen in sequential trials improved objective partial and complete response (CR) rates. Here, we evaluated the importance of adding TBI to the adoptive transfer of tumor-infiltrating lymphocytes (TIL) in a randomized fashion. PATIENTS AND
methodsA total of 101 patients with metastatic melanoma, including 76 patients with M1c disease, were randomly assigned to receive nonmyeloablative chemotherapy with or without 1,200 cGy TBI before transfer of tumor-infiltrating lymphcytes. Primary end points were CR rate (as defined by Response Evaluation Criteria in Solid Tumors v1.0) and overall survival (OS). Clinical and laboratory data were analyzed for correlates of response.
resultsCR rates were 24% in both groups (12 of 50 v 12 of 51), and OS was also similar (median OS, 38.2 v 36.6 months; hazard ratio, 1.11; 95% CI, 0.65 to 1.91; P = .71). Thrombotic microangiopathy was an adverse event unique to the TBI arm and occurred in 13 of 48 treated patients. With a median potential follow-up of 40.9 months, only one of 24 patients who achieved a CR recurred.
conclusionAdoptive cell transfer can mediate durable complete regressions in 24% of patients with metastatic melanoma, with median survival > 3 years. Results were similar using chemotherapy preparative regimens with or without addition of TBI.
Indexed as
Immunotherapy, AdoptiveLymphocyte DepletionAdolescentAdultAgedFemaleHumansLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedNeoplasm MetastasisProspective StudiesWhole-Body Irradiation
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NCT01319565ClinicalTrials.gov
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.