Evidence map›Paper›PMID 35258987›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O

Federica Morano, Alessandra Raimondi, Filippo Pagani, Sara Lonardi, Lisa Salvatore, Chiara Cremolini, Sabina Murgioni, Giovanni Randon, Federica Palermo, Lorenzo Antonuzzo and 23 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 86 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 4 pooled it
12.6field-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.

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

86 citing papers in PubMed, 4 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Pooled it
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  14. Acquired High Tumor Mutational Burden and Activity of Immunotherapy after Targeted Therapy in Microsatellite Stable Colorectal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
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26 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

33 authors at 11 institutions in 1 country.

Federica MoranoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-5306-3596
Alessandra RaimondiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Filippo PaganiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Sara LonardiMedical Oncology 3, Istituto Oncologico Veneto IOV-IRCSS, Padua, Italy.ORCID 0000-0002-7593-8138
Lisa SalvatoreComprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0003-3864-0719
Chiara CremoliniUnit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.ORCID 0000-0002-0520-4841
Sabina MurgioniMedical Oncology 1, Istituto Oncologico Veneto IOV-IRCSS, Padua, Italy.ORCID 0000-0002-4682-9872
Giovanni RandonDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Federica PalermoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Lorenzo AntonuzzoClinical Oncology Unit, Careggi University Hospital, Florence, Italy.
Nicoletta PellaDepartment of Oncology, ASUFC University Hospital of Udine, Udine, Italy.
Patrizia RaccaColoRectal Cancer Unit, Department of Oncology, AOU Città della Salute e della Scienza di Torino, Turin, Italy.
Michele PrisciandaroDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Monica NigerDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-9055-5338
Francesca CortiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0001-5245-0060
Francesca BergamoMedical Oncology 1, Istituto Oncologico Veneto IOV-IRCSS, Padua, Italy.ORCID 0000-0002-8795-4653
Alberto ZaniboniMedical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.
Margherita RattiDepartment of Medical Oncology, Azienda Socio Sanitaria Territoriale of Cremona, Cremona, Italy.
Michele PalazzoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Celeste CagnazzoDepartment of Public Health and Pediatric Sciences, University of Turin, Turin, Italy.ORCID 0000-0003-4055-3139
Maria Alessandra CalegariComprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0001-6856-2593
Federica MarmorinoUnit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Iolanda CaponeDepartment of the Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.ORCID 0000-0002-6572-614X
Elena ConcaDepartment of the Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.ORCID 0000-0003-2052-8104
Adele BusicoDepartment of the Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.ORCID 0000-0002-5808-0387
Silvia BrichDepartment of the Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Elena TamboriniDepartment of the Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Federica PerroneDepartment of the Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Massimo Di MaioDepartment of Oncology, University of Turin, Division of Medical Oncology, Ordine Mauriziano Hospital, Turin, Italy.ORCID 0000-0001-8906-3785
Massimo MilioneDepartment of the Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Maria Di BartolomeoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Filippo de BraudDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Filippo PietrantonioDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-8530-8420
Fondazione IRCCS Istituto Nazionale dei Tumori · ITIstituto Oncologico Veneto · ITUniversity of Pisa · ITAgostino Gemelli University Polyclinic · ITA. O. Ordine Mauriziano di Torino · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Ospedaliero-Universitaria Careggi · ITFondazione Poliambulanza Istituto Ospedaliero · ITIstituti Ospitalieri di Cremona · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis is a multicenter, single-arm phase II trial evaluating the efficacy and safety of an immune-sensitizing strategy with temozolomide priming followed by a combination of low-dose ipilimumab and nivolumab in patients with microsatellite-stable (MSS) and O PATIENTS AND

methodsPatients with pretreated mCRC were centrally prescreened for MSS status and MGMT silencing (ie, lack of MGMT expression by immunohistochemistry plus

resultsAmong 716 prescreened patients, 204 (29%) were molecularly eligible and 135 started the first treatment part. Among these, 102 (76%) were discontinued because of death or disease progression on temozolomide priming, whereas 33 patients (24%) who achieved disease control started the second treatment part and represented the final study population. After a median follow-up of 23.1 months (interquartile range, 14.9-24.6 months), 8-month PFS rate was 36%. Median PFS and overall survival were 7.0 and 18.4 months, respectively, and overall response rate was 45%. Grade 3-4 immune-related adverse events were skin rash (6%), colitis (3%), and hypophysitis (3%). No unexpected adverse events or treatment-related deaths were reported.

conclusionThe MAYA study provided proof-of-concept that a sequence of temozolomide priming followed by a combination of low-dose ipilimumab and nivolumab may induce durable clinical benefit in MSS and MGMT-silenced mCRC.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabMicrosatellite RepeatsNivolumabO(6)-Methylguanine-DNA MethyltransferaseTemozolomideIpilimumabNivolumabO(6)-Methylguanine-DNA MethyltransferaseTemozolomide

Identifiers

PMID35258987
PMCPMC9084437
OpenAlexW4220750583

What OpenQuestion holds

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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.