Evidence map›Paper›PMID 30747243›Full record

Trial reportCancer immunology, immunotherapy : CII2019

Phase II clinical trial of adoptive cell therapy for patients with metastatic melanoma with autologous tumor-infiltrating lymphocytes and low-dose interleukin-2.

Linh T Nguyen, Samuel D Saibil, Valentin Sotov, Michael X Le, Leila Khoja, Danny Ghazarian, Luisa Bonilla, Habeeb Majeed, David Hogg, Anthony M Joshua and 34 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01883323 (Phase II Study Evaluating The Infusion Of Autologous Tumor-Infiltrating Lymphocytes), which is not on this map. Cited by 89 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 2 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT01883323 phase2completednot on this map

Phase II Study Evaluating The Infusion Of Autologous Tumor-Infiltrating Lymphocytes (TILs) And Low-Dose Interleukin-2 (IL-2) Therapy Following A Preparative Regimen Of Non-Myeloablative Lymphodepletion Using Cyclophosphamide And Fludarabine In Patients With Metastatic Melanoma

TypeinterventionalSponsorUniversity Health Network, TorontoRan2013 to 2018Enrolled12ConditionsMetastatic, Stage III or Stage IV, MelanomaArmsCyclophosphamide, Fludarabine, Tumor-Infiltrating Lymphocytes, Low-Dose Interleukin
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 2 syntheses or guidelines pooled it, 134 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Cell-Based Therapies for Solid Tumors: Challenges and Advances.International journal of molecular sciences · 2025
    Review
  19. Review
  20. Article

29 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

44 authors at 3 institutions in 2 countries.

Linh T NguyenTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.ORCID http://orcid.org/0000-0003-3470-1318
Samuel D SaibilDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Valentin SotovTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Michael X LeTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Leila KhojaDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Danny GhazarianDepartment of Laboratory Medicine, University Health Network, Toronto, Canada.
Luisa BonillaDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Habeeb MajeedDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
David HoggDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Anthony M JoshuaDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Michael CrumpDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Norman FrankeDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Anna SpreaficoDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Aaron HansenDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Ayman Al-HabeebDepartment of Laboratory Medicine, University Health Network, Toronto, Canada.
Wey LeongDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
Alexandra EassonDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
Michael ReedijkDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
David P GoldsteinDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
David McCreadyDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
Kazuhiro YasufukuDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
Thomas WaddellDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
Marcelo CypelDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
Andrew PierreDepartment of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
Bianzheng ZhangDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Sarah Boross-HarmerTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Jane CipolloneTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Megan NellesTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Elizabeth ScheidTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Michael FyrstaTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Charlotte S LoTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Jessica NieTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Jennifer Y YamTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Pei Hua YenTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Diana GrayTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Vinicius MottaTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Alisha R ElfordTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Stephanie DeLucaDepartment of Pharmacy, Princess Margaret Cancer Centre, Toronto, Canada.
Lisa WangDrug Development Program, Princess Margaret Cancer Centre, Toronto, Canada.
Stephanie EffendiDrug Development Program, Princess Margaret Cancer Centre, Toronto, Canada.
Ragitha EllencheryDrug Development Program, Princess Margaret Cancer Centre, Toronto, Canada.
Naoto HiranoTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Pamela S OhashiTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada.
Marcus O ButlerTumor Immunotherapy Program, Princess Margaret Cancer Centre, Toronto, Canada. Marcus.Butler@uhn.ca.ORCID http://orcid.org/0000-0002-9840-7057
Princess Margaret Cancer Centre · CAUniversity Health Network · CAUniversity of Toronto · CA

Funding

Princess Margaret Cancer Foundation n/a
6 · The paper itself

Abstract

Adoptive cell therapy using autologous tumor-infiltrating lymphocytes (TIL) has shown significant clinical benefit, but is limited by toxicities due to a requirement for post-infusion interleukin-2 (IL-2), for which high dose is standard. To assess a modified TIL protocol using lower dose IL-2, we performed a single institution phase II protocol in unresectable, metastatic melanoma. The primary endpoint was response rate. Secondary endpoints were safety and assessment of immune correlates following TIL infusion. Twelve metastatic melanoma patients were treated with non-myeloablative lymphodepleting chemotherapy, TIL, and low-dose subcutaneous IL-2 (125,000 IU/kg/day, maximum 9-10 doses over 2 weeks). All but one patient had previously progressed after treatment with immune checkpoint inhibitors. No unexpected adverse events were observed, and patients received an average of 6.8 doses of IL-2. By RECIST v1.1, two patients experienced a partial response, one patient had an unconfirmed partial response, and six had stable disease. Biomarker assessment confirmed an increase in IL-15 levels following lymphodepleting chemotherapy as expected and a lack of peripheral regulatory T-cell expansion following protocol treatment. Interrogation of the TIL infusion product and monitoring of the peripheral blood following infusion suggested engraftment of TIL. In one responding patient, a population of T cells expressing a T-cell receptor Vβ chain that was dominant in the infusion product was present at a high percentage in peripheral blood more than 2 years after TIL infusion. This study shows that this protocol of low-dose IL-2 following adoptive cell transfer of TIL is feasible and clinically active. (ClinicalTrials.gov identifier NCT01883323.).

Indexed as

AdultCell ProliferationCells, CulturedFemaleHumansImmunotherapy, AdoptiveInterleukin-15Interleukin-2Lymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedNeoplasm MetastasisSkin NeoplasmsTreatment OutcomeInterleukin-15Interleukin-2Adoptive cell therapyClinical trialInterleukin-2Metastatic melanomaTumor-infiltrating lymphocytes

Identifiers

PMID30747243
PMCPMC11028227
OpenAlexW2911882091

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.