Evidence map›Paper›PMID 36083313›Full record

ArticleCancer immunology, immunotherapy : CII2023

A Phase I-II multicenter trial with Avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients; GEMCAD 1602 study.

Marta Español-Rego, Carlos Fernández-Martos, Elena Elez, Carles Foguet, Leire Pedrosa, Nuria Rodríguez, Ana Ruiz-Casado, Estela Pineda, Joan Cid, Raquel Cabezón and 12 more

Open access · hybridFull text readMulticenter Study
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 8% 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.

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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

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  16. Tumor Antigens beyond the Human Exome.International journal of molecular sciences · 2024
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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

22 authors at 8 institutions in 2 countries.

Marta Español-RegoImmunology Department, Hospital Clínic, Barcelona, Spain.
Carlos Fernández-MartosMedical Oncology Department, Instituto Valenciano de Oncología, Valencia, Spain.
Elena ElezMedical Oncology Department, Vall d'Hebrón Barcelona Hospital Campus, Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.
Carles FoguetDepartment of Biochemistry and Molecular Medicine, Universitat de Barcelona, Barcelona, Spain.
Leire PedrosaTranslational Genomics and Targeted Therapeutics in Solid Tumors Group, Medical Oncology Department, Hospital Clinic of Barcelona, IDIBAPS, University of Barcelona, C. Villarroel, 170. 08036, Barcelona, Spain.
Nuria RodríguezMedical Oncology Department, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Madrid, Spain.
Ana Ruiz-CasadoMedical Oncology Department, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
Estela PinedaTranslational Genomics and Targeted Therapeutics in Solid Tumors Group, Medical Oncology Department, Hospital Clinic of Barcelona, IDIBAPS, University of Barcelona, C. Villarroel, 170. 08036, Barcelona, Spain.
Joan CidApheresis & Cellular Therapy Unit, Department of Hemotherapy and Hemostasis, IDIBAPS, Hospital Clínic, Barcelona, Spain.
Raquel CabezónImmunology Department, Hospital Clínic, Barcelona, Spain.
Helena OliveresTranslational Genomics and Targeted Therapeutics in Solid Tumors Group, Medical Oncology Department, Hospital Clinic of Barcelona, IDIBAPS, University of Barcelona, C. Villarroel, 170. 08036, Barcelona, Spain.
Miquel LozanoApheresis & Cellular Therapy Unit, Department of Hemotherapy and Hemostasis, IDIBAPS, Hospital Clínic, Barcelona, Spain.
Angels GinésEndoscopic Unit, Gastrointestinal Service, Hospital Clínic Barcelona, IDIBAPS, CIBERehd, University of Barcelona, Barcelona, Spain.
Angeles García-CriadoRadiology Department, Hospital Clínic Barcelona, Barcelona, Spain.
Juan Ramon AyusoRadiology Department, Hospital Clínic Barcelona, Barcelona, Spain.
Mario PagésRadiology Department, Hospital Clínic Barcelona, Barcelona, Spain.
Miriam CuatrecasasPathology Department, Hospital Clínic de Barcelona, Barcelona, Spain.
Ferràn TorresBiostatistics Unit, Faculty of Medicine, Autonomous University of Barcelona, Barcelona, Spain.
Timothy ThomsonBarcelona Institute for Molecular Biology, National Science Council (IBMB-CSIC), Barcelona, Spain.
Marta CascanteDepartment of Biochemistry and Molecular Medicine, Universitat de Barcelona, Barcelona, Spain.
Daniel Benítez-RibasImmunology Department, Hospital Clínic, Barcelona, Spain. DBENITEZR@clinic.cat.
Joan MaurelTranslational Genomics and Targeted Therapeutics in Solid Tumors Group, Medical Oncology Department, Hospital Clinic of Barcelona, IDIBAPS, University of Barcelona, C. Villarroel, 170. 08036, Barcelona, Spain. JMAUREL@clinic.cat.
Hospital Clínic de Barcelona · ESInstituto de Salud Carlos III · ESUniversitat de Barcelona · ESUniversitat Autònoma de Barcelona · ESCentro de Investigación Biomédica en Red de Cáncer · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESFundación Instituto Valenciano de Oncología · ESHospital Universitario Puerta de Hierro Majadahonda · ES

Funding

Catalan Agency for Management of University and Research Grants (AGAUR) 2014-SGR-474Catalan Agency for Management of University and Research Grants (AGAUR) 2017-SGR-1174Fundació la Marató de TV3 201330.10Fundación Olga Torres Modalitat A.2019/2020Hospital Clinic de Barcelona Premi Fi de Residència Emili LetangInstituto de Salud Carlos III PI13/01728Instituto de Salud Carlos III PI17/00732Plan Nacional de I+D PID-107139RB-C21Plan Nacional de I+D PID2020-115051RB-I00
6 · The paper itself

Abstract

backgroundImmune check-point blockade (ICB) has shown clinical benefit in mismatch repair-deficient/microsatellite instability high metastatic colorectal cancer (mCRC) but not in mismatch repair-proficient/microsatellite stable patients. Cancer vaccines with autologous dendritic cells (ADC) could be a complementary therapeutic approach to ICB as this combination has the potential to achieve synergistic effects.

methodsThis was a Phase I/II multicentric study with translational sub-studies, to evaluate the safety, pharmacodynamics and anti-tumor effects of Avelumab plus ADC vaccine in heavily pre-treated MSS mCRC patients. Primary objective was to determine the maximum tolerated dose and the efficacy of the combination. The primary end-point was 40% progression-free survival at 6 months with a 2 Simon Stage.

resultsA total of 28 patients were screened and 19 pts were included. Combined therapy was safe and well tolerated. An interim analysis (Simon design first-stage) recommended early termination because only 2/19 (11%) patients were disease free at 6 months. Median PFS was 3.1 months [2.1-5.3 months] and overall survival was 12.2 months [3.2-23.2 months]. Stimulation of immune system was observed in vitro but not clinically. The evaluation of basal RNA-seq noted significant changes between pre and post-therapy liver biopsies related to lipid metabolism and transport, inflammation and oxidative stress pathways.

conclusionsThe combination of Avelumab plus ADC vaccine is safe and well tolerated but exhibited modest clinical activity. Our study describes, for the first-time, a de novo post-therapy metabolic rewiring, that could represent novel immunotherapy-induced tumor vulnerabilities.

Indexed as

Cancer VaccinesColonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDendritic CellsDNA Mismatch RepairHumansAntibodies, Monoclonal, HumanizedavelumabCancer VaccinesMetabolismResistanceVaccines

Identifiers

PMID36083313
PMCPMC10025226
OpenAlexW4295086517

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read45
identifiers read2
Read underepoch 390

Registered trials

None linked

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.