Evidence map›Paper›PMID 40169866›Full record

Trial reportNature medicine2025

Neoantigen-specific tumor-infiltrating lymphocytes in gastrointestinal cancers: a phase 2 trial.

Frank J Lowery, Stephanie L Goff, Billel Gasmi, Maria R Parkhurst, Nivedita M Ratnam, Hyunmi K Halas, Thomas E Shelton, Michelle M Langhan, Aarushi Bhasin, Aaron J Dinerman and 23 more

Erratum issuedAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Predicting Neoantigen Immunogenicity frombioRxiv : the preprint server for biology · 2026
    Article
  6. Innovative immunotherapeutic strategies for thyroid cancer: challenges and opportunities.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  7. Cell surface ADGRG1 and CD86 expression identifies antitumor CD4Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  8. Review
  9. Article
  10. The evolution of cellular-based immunotherapy in the treatment of gastric cancer: an overview of clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  11. Review
  12. Article
  13. Article
  14. CD4Science (New York, N.Y.) · 2026
    Article
  15. Review
  16. Review
  17. Article
  18. Spatiotemporal dynamics of adoptively transferred stem-like CD8bioRxiv : the preprint server for biology · 2026
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors.

Frank J Lowery *National Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Stephanie L Goff *National Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA. stephanie.goff@nih.gov.ORCID http://orcid.org/0000-0003-3317-9804
Billel GasmiNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Maria R ParkhurstNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Nivedita M RatnamNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Hyunmi K HalasNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0009-0007-3933-6459
Thomas E SheltonNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Michelle M LanghanNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Aarushi BhasinNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Aaron J DinermanNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Victoria DulembaNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Ian S GoldlustNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Alexandra M GustafsonNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Abraham A HakimNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Kyle J HitscherichNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Lisa M KenneyNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Lior LevyNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-2727-025X
Juliette G Rault-WangNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-6718-9712
Alakesh BeraNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Satyajit RayNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Courtney D SeaveyNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Chuong D HoangNational Cancer Institute, Center for Cancer Research, Thoracic Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0000-0003-4016-1434
Jonathan M HernandezNational Cancer Institute, Center for Cancer Research, Surgical Oncology Program, Bethesda, MD, USA.
Jared J GartnerNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0000-0003-2924-3519
Sivasish SindiriNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Todd D PrickettNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Lori S McIntyreNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Sri KrishnaNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0000-0003-4994-3758
Paul F RobbinsNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-1260-8123
Nicholas D KlemenNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
Mei Li M KwongNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.
James C YangNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA.ORCID http://orcid.org/0000-0001-8935-5008
Steven A RosenbergNational Cancer Institute, Center for Cancer Research, Surgery Branch, Bethesda, MD, USA. sar@nih.gov.ORCID http://orcid.org/0000-0002-8939-8910

Funding

Building on the success of the adoptive immunotherapy of cancerZIABC010763 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2020
$25.0M
Intramural NIH HHS ZIA BC010763
6 · The paper itself

Abstract

Adoptive transfer of unselected autologous tumor-infiltrating lymphocytes (TILs) has mediated meaningful clinical responses in patients with metastatic melanoma but not in cancers of gastrointestinal epithelial origin. In an evolving single-arm phase 2 trial design, TILs were derived from and administered to 91 patients with treatment-refractory mismatch repair proficient metastatic gastrointestinal cancers in a schema with lymphodepleting chemotherapy and high-dose interleukin-2 (three cohorts of an ongoing trial). The primary endpoint of this study was the objective response rate as measured using Response Evaluation Criteria in Solid Tumors 1.0; safety was a descriptive secondary endpoint. In the pilot phase, no clinical responses were observed in 18 patients to bulk, unselected TILs; however, when TILs were screened and selected for neoantigen recognition (SEL-TIL), three responses were seen in 39 patients (7.7% (95% confidence interval (CI): 2.7-20.3)). Based on the high levels of programmed cell death protein 1 in the infused TILs, pembrolizumab was added to the regimen (SEL-TIL + P), and eight objective responses were seen in 34 patients (23.5% (95% CI: 12.4-40.0)). All patients experienced transient severe hematologic toxicities from chemotherapy. Seven (10%) patients required critical care support. Exploratory analyses for laboratory and clinical correlates of response were performed for the SEL-TIL and SEL-TIL + P treatment arms. Response was associated with recognition of an increased number of targeted neoantigens and an increased number of administered CD4

Indexed as

Antigens, NeoplasmGastrointestinal NeoplasmsLymphocytes, Tumor-InfiltratingAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedFemaleHumansInterleukin-2MaleMiddle AgedProgrammed Cell Death 1 ReceptorAntibodies, Monoclonal, HumanizedAntigens, NeoplasmInterleukin-2pembrolizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID40169866
PMCPMC12315913

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Registered trials

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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.