Evidence map›Paper›PMID 37620627›Full record

Trial reportNature medicine2023

Nivolumab plus ipilimumab in advanced salivary gland cancer: a phase 2 trial.

Joris L Vos, Bharat Burman, Swati Jain, Conall W R Fitzgerald, Eric J Sherman, Lara A Dunn, James V Fetten, Loren S Michel, Anuja Kriplani, Kenneth K Ng and 19 more

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

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03172624 (A Phase II Study of Nivolumab Plus Ipilimumab in Patients With Recurrent/Metastatic Salivary Cancers), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
15.6field-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.

NCT03172624 phase2completednot on this map

A Phase II Study of Nivolumab Plus Ipilimumab in Patients With Recurrent/Metastatic Salivary Cancers

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2017 to 2024Enrolled64ConditionsSalivary Gland CancerArmsNivolumab, Ipilimumab
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Axitinib plus Avelumab in Recurrent/Metastatic Adenoid Cystic Carcinoma: Biomarker Analysis and Updated Results of the Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Phase 2 Trial of Regorafenib in Recurrent/Metastatic Adenoid Cystic Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Contemporary Management of Malignancies of the Parotid Gland: A State-of-the-Art Review.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
    Review
  17. Review
  18. Article
  19. Review
  20. Article
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

29 authors at 4 institutions in 2 countries.

Joris L Vos *Head and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0002-8318-5455
Bharat Burman *Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Swati JainHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0002-8625-8218
Conall W R FitzgeraldHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Eric J ShermanDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Lara A DunnDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
James V FettenDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Loren S MichelDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Anuja KriplaniDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Kenneth K NgDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Juliana EngDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Vatche TchekmedyianDepartment of Medicine, Maine Medical Center-Tufts University School of Medicine, Portland, ME, USA.
Sofia HaqueDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Nora KatabiDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Fengshen KuoHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0003-1797-2896
Catherine Y HanHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Zaineb NadeemHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Wei YangHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Vladimir MakarovCenter for Immunotherapy and Precision Immuno-oncology, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-4104-5876
Raghvendra M SrivastavaCenter for Immunotherapy and Precision Immuno-oncology, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Irina OstrovnayaDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Manu PrasadHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Charlotte L ZuurDepartment of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.ORCID 0000-0002-1777-012X
Nadeem RiazDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0001-9873-5862
David G PfisterDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0002-2109-3221
Christopher A KlebanoffDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0001-9645-3896
Timothy A ChanCenter for Immunotherapy and Precision Immuno-oncology, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-9265-0283
Alan L HoDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. hoa@mskcc.org.ORCID 0000-0002-6885-3742
Luc G T MorrisHead and Neck Service and Immunogenomic Oncology Platform, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. morrisl@mskcc.org.ORCID 0000-0002-4417-2280
Memorial Sloan Kettering Cancer Center · USCleveland Clinic Lerner College of Medicine · USLeiden University Medical Center · NLTufts University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Targeting Oncogenic Pathways in Genetically Complex SarcomasP50CA217694 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI William D. Tap · 2018 to 2026
$21.5M
TOWARDS PRECISION IMMUNO-ONCOLOGY: UNRAVELING THE GENOMIC DETERMINANTS AND MECHANISMS UNDERLYING IMMUNOTHERAPY EFFICACY AND RESISTANCER35CA232097 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CHAN, TIMOTHY AN-THY · 2018 to 2024
$7.0M
Molecular mechanisms of T cell responses to a clonal neoantigen resulting from a mutated driver oncogene.R37CA259177 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Christopher Austin Klebanoff · 2021 to 2026
$3.1M
Identifying and targeting neoantigens in aggressive salivary carcinomasR01DE027738 · NIDCR · SLOAN-KETTERING INST CAN RESEARCH · PI CHAN, TIMOTHY AN-THY, HO, ALAN L. · 2018 to 2022
$2.8M
TOX-driven CD8 T cell differentiation and dysfunction in tumorsR01CA269733 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Andrea Schietinger · 2023 to 2026
$2.4M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA217694NCI NIH HHS R01 CA269733NCI NIH HHS R35 CA232097NCI NIH HHS R37 CA259177NIDCR NIH HHS R01 DE027738
6 · The paper itself

Abstract

Salivary gland cancers (SGCs) are rare, aggressive cancers without effective treatments when metastasized. We conducted a phase 2 trial evaluating nivolumab (nivo, anti-PD-1) and ipilimumab (ipi, anti-CTLA-4) in 64 patients with metastatic SGC enrolled in two histology-based cohorts (32 patients each): adenoid cystic carcinoma (ACC; cohort 1) and other SGCs (cohort 2). The primary efficacy endpoint (≥4 objective responses) was met in cohort 2 (5/32, 16%) but not in cohort 1 (2/32, 6%). Treatment safety/tolerability and progression-free survival (PFS) were secondary endpoints. Treatment-related adverse events grade ≥3 occurred in 24 of 64 (38%) patients across both cohorts, and median PFS was 4.4 months (95% confidence interval (CI): 2.4, 8.3) and 2.2 months (95% CI: 1.8, 5.3) for cohorts 1 and 2, respectively. We present whole-exome, RNA and T cell receptor (TCR) sequencing data from pre-treatment and on-treatment tumors and immune cell flow cytometry and TCR sequencing from peripheral blood at serial timepoints. Responding tumors universally demonstrated clonal expansion of pre-existing T cells and mutational contraction. Responding ACCs harbored neoantigens, including fusion-derived neoepitopes, that induced T cell responses ex vivo. This study shows that nivo+ipi has limited efficacy in ACC, albeit with infrequent, exceptional responses, and that it could be promising for non-ACC SGCs, particularly salivary duct carcinomas. ClinicalTrials.gov identifier: NCT03172624 .

Indexed as

CarcinomaSalivary Gland NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabNivolumabReceptors, Antigen, T-CellIpilimumabNivolumabReceptors, Antigen, T-Cell

Identifiers

PMID37620627
PMCPMC11293616
OpenAlexW4386135015

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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.