Evidence map›Paper›PMID 34887574›Full record

Trial reportNature medicine2021

A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma.

Julie Westerlin Kjeldsen, Cathrine Lund Lorentzen, Evelina Martinenaite, Eva Ellebaek, Marco Donia, Rikke Boedker Holmstroem, Tobias Wirenfeldt Klausen, Cecilie Oelvang Madsen, Shamaila Munir Ahmed, Stine Emilie Weis-Banke and 7 more

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 142 papers.

0numbers the graph read from it
0cells of the map it votes in
142citing papers in PubMed
12.9field-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.

NCT03047928 phase1 / phase2completednot on this map

Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic Melanoma

TypeinterventionalSponsorInge Marie SvaneRan2018 to 2022Enrolled48ConditionsMetastatic MelanomaArmsNivolumab, PD-L1/IDO peptide vaccine
NCT05912244 phase2active not recruitingnot on this mapstarted 2023, after this paper: background citation

A Phase II Study of IO102/IO103 and Nivolumab-relatlimab Fixed Dose Combination in Untreated, Unresectable Stage III/IV Melanoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2023 to 2027Enrolled43ConditionsMelanomaArmsIO102/IO103, Nivolumab-Relatlimab
3 · Its place in the literature

Who cites it

142 citing papers in PubMed, 199 citations in OpenAlex.

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  3. Translational investigations in the HN1901 phase II window-of-opportunity study investigating the biological activity of an IDO1 (IO102) and PD-L1 (IO103) immune-modulatory peptide cancer vaccines in squamous cell carcinoma of the head and neck.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
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  11. Advances in Cancer Immunotherapy for Solid Tumors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
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  14. Strategies to target PD-1/PD-L1 in the tumor microenvironment.Cellular oncology (Dordrecht, Netherlands) · 2026
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82 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Julie Westerlin Kjeldsen *National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.ORCID http://orcid.org/0000-0001-6201-1758
Cathrine Lund Lorentzen *National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
Evelina MartinenaiteNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
Eva EllebaekNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.ORCID http://orcid.org/0000-0001-6748-9232
Marco DoniaNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.ORCID http://orcid.org/0000-0003-4966-9752
Rikke Boedker HolmstroemNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.ORCID http://orcid.org/0000-0002-5476-9937
Tobias Wirenfeldt KlausenNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
Cecilie Oelvang MadsenNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
Shamaila Munir AhmedNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
Stine Emilie Weis-BankeNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.ORCID http://orcid.org/0000-0002-6037-494X
Morten Orebo HolmströmNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
Helle Westergren HendelDepartment of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Herlev, Denmark.
Eva EhrnroothIO Biotech Aps, Copenhagen, Denmark.
Mai-Britt ZoccaIO Biotech Aps, Copenhagen, Denmark.
Ayako Wakatsuki PedersenIO Biotech Aps, Copenhagen, Denmark.
Mads Hald AndersenNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
Inge Marie SvaneNational Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, Herlev, Denmark. inge.marie.svane@regionh.dk.ORCID http://orcid.org/0000-0002-9451-6037
Copenhagen University Hospital · DKHerlev Hospital · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Anti-programmed death (PD)-1 (aPD1) therapy is an effective treatment for metastatic melanoma (MM); however, over 50% of patients progress due to resistance. We tested a first-in-class immune-modulatory vaccine (IO102/IO103) against indoleamine 2,3-dioxygenase (IDO) and PD ligand 1 (PD-L1), targeting immunosuppressive cells and tumor cells expressing IDO and/or PD-L1 (IDO/PD-L1), combined with nivolumab. Thirty aPD1 therapy-naive patients with MM were treated in a phase 1/2 study ( https://clinicaltrials.gov/ , NCT03047928). The primary endpoint was feasibility and safety; the systemic toxicity profile was comparable to that of nivolumab monotherapy. Secondary endpoints were efficacy and immunogenicity; an objective response rate (ORR) of 80% (confidence interval (CI), 62.7-90.5%) was reached, with 43% (CI, 27.4-60.8%) complete responses. After a median follow-up of 22.9 months, the median progression-free survival (PFS) was 26 months (CI, 15.4-69 months). Median overall survival (OS) was not reached. Vaccine-specific responses assessed in vitro were detected in the blood of >93% of patients during vaccination. Vaccine-reactive T cells comprised CD4

Indexed as

Adjuvants, ImmunologicB7-H1 AntigenCancer VaccinesHumansImmune Checkpoint InhibitorsIndoleamine-Pyrrole 2,3,-DioxygenaseMelanomaNivolumabSkin NeoplasmsAdjuvants, ImmunologicB7-H1 AntigenCancer VaccinesCD274 protein, humanImmune Checkpoint InhibitorsIndoleamine-Pyrrole 2,3,-DioxygenaseNivolumab

Identifiers

PMID34887574
PMCPMC8904254
OpenAlexW4200495164

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.