Evidence map›Paper›PMID 32867715›Full record

ArticleBMC cancer2020

Phase II study on first-line treatment of NIVolumab in combination with folfoxiri/bevacizumab in patients with Advanced COloRectal cancer RAS or BRAF mutated - NIVACOR trial (GOIRC-03-2018).

Angela Damato, Francesco Iachetta, Lorenzo Antonuzzo, Guglielmo Nasti, Francesca Bergamo, Roberto Bordonaro, Evaristo Maiello, Alberto Zaniboni, Giuseppe Tonini, Alessandra Romagnani and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04072198 (Phase II Study on NIVolumab in Combination With FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced COloRectal Cancer RASm/BRAFm Patients), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
1.4field-weighted citation impact, top 16% 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.

NCT04072198 phase2completednot on this map

Phase II Study on NIVolumab in Combination With FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced COloRectal Cancer RASm/BRAFm Patients

TypeinterventionalSponsorGruppo Oncologico Italiano di Ricerca ClinicaRan2019 to 2024Enrolled73ConditionsColorectal CancerArmsNivolumab, Bevacizumab, Irinotecan, Oxaliplatin, Leucovorin
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 29 citations in OpenAlex.

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  9. Regulation of VEGF-A expression and VEGF-A-targeted therapy in malignant tumors.Journal of cancer research and clinical oncology · 2024
    Review
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  14. New developments in targeted therapy for metastatic colorectal cancer.Therapeutic advances in medical oncology · 2023
    Review
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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

13 authors at 9 institutions in 1 country.

Angela DamatoMedical Oncology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Oncologia Medica, Dipartimento Oncologico e Tecnologie Avanzate, Viale Risorgimento 80, 42123, Reggio Emilia, Italy. angela.damato@ausl.re.it.ORCID http://orcid.org/0000-0001-8286-1274
Francesco IachettaMedical Oncology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Oncologia Medica, Dipartimento Oncologico e Tecnologie Avanzate, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
Lorenzo AntonuzzoAzienda Ospedaliero - Universitaria Careggi, Dipartimento di Oncologia Medica, Largo G. Alessandro Brambilla 3, 50134, Firenze, Italy.
Guglielmo NastiIstituto Nazionale Tumori IRCCS Fondazione G. Pascale, Dipartimento di Oncologia Addominale, Via Mariano Semmola 53, Napoli, Italy.
Francesca BergamoIstituto Oncologico Veneto I.R.C.C.S., S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata 64, 35128, Padova, Italy.
Roberto BordonaroARNAS Garibaldi - Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi, U.O.C. Oncologia Medica, Via Palermo 636, 95122, Catania, Italy.
Evaristo MaielloCasa Sollievo della Sofferenza, Oncologia Medica, Dipartimento Onco-Ematologico, Viale Cappuccini 1, 71013, San Giovanni Rotondo, Italy.
Alberto ZaniboniFondazione Poliambulanza Istituto Ospedaliero, U.O. Oncologia, Dipartimento Oncologico, Vial Leonida Bissolati 57, 25124, Brescia, Italy.
Giuseppe ToniniPoliclinico Universitario Campus Bio-Medico, Oncologia Medica, Via Alvaro del Portillo 200, 00128, Roma, Italy.
Alessandra RomagnaniMedical Oncology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Oncologia Medica, Dipartimento Oncologico e Tecnologie Avanzate, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
Annalisa BerselliMedical Oncology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Oncologia Medica, Dipartimento Oncologico e Tecnologie Avanzate, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
Nicola NormannoIstituto Nazionale Tumori IRCCS Fondazione G. Pascale, Dipartimento della Ricerca, Via Mariano Semmola 53, Napoli, Italy.
Carmine PintoMedical Oncology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Oncologia Medica, Dipartimento Oncologico e Tecnologie Avanzate, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
Tecnologie Avanzate (Italy) · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITAzienda Ospedaliero-Universitaria Careggi · ITCampus Bio Medico University Hospital · ITCasa Sollievo della Sofferenza · ITFondazione Poliambulanza Istituto Ospedaliero · ITIstituto Oncologico Veneto · ITOspedale Garibaldi · ITUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab has shown to be one of the therapeutic regimens in first line with the highest activity in patients (pts.) with metastatic colorectal cancer (mCRC) unselected for biomolecular alterations. Generally, tumors co-opt the programmed death-1/ligand 1 (PD-1/PD-L1) signaling pathway as one key mechanism to evade immune surveillance. As today, anti-PD-1 monoclonal antibodies are FDA approved only for DNA mismatch repair deficient/microsatellite instability-high (MMRd/MSI-H), which represent only about 5% among all mCRC. Nowadays, there are no data demonstrating anti PD-1 activity in proficient and stable disease (MMRp/MSS). A different target in mCRC is also the Vascular Endothelial Growth Factor A (VEGF-A), which acts on endothelial cells to stimulate angiogenesis. VEGF-A inhibition with bevacizumab has shown to increase the immune cell infiltration, providing a solid rationale for combining VEGF targeted agents with immune checkpoint inhibitors. Based on these evidences, we explore the combination of triplet chemotherapy (FOLFOXIRI) with bevacizumab and nivolumab in pts. with mCRC RAS/BRAF mutant regardless of microsatellite status. METHODS/

designThis is a prospective, open-label, multicentric phase II trial where pts. with mCRC RAS/BRAF mutated, in first line will receive nivolumab in combination with FOLFOXIRI/bevacizumab every 2 weeks for 8 cycles followed by maintenance with bevacizumab plus nivolumab every 2 weeks. Bevacizumab will be administered intravenously at dose of 5 mg/kg every 2 weeks and nivolumab intravenously as a flat dose of 240 mg every 2 weeks. The primary endpoint is the overall response rate (ORR). This study hypothesis is that the treatment is able to improve the ORR from 66 to 80%. Secondary endpoints include OS, safety, time to progression, duration of response. Collateral translational studies evaluate the i) tumor mutational burden, and ii) genetic alterations by circulating free DNA (cfDNA) obtained from plasma samples. The trial is open to enrollment, 9 of planned 70 pts. have been enrolled.

trial registrationNIVACOR is registered at ClinicalTrials.gov: NCT04072198 , August 28, 2019.

Indexed as

MutationAdolescentAdultAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinClinical Trials, Phase II as TopicColorectal NeoplasmsFemaleFluorouracilHumansLeucovorinMaleMiddle AgedAntineoplastic Agents, ImmunologicalBevacizumabBRAF protein, humanCamptothecinFluorouracilLeucovorinNivolumabOrganoplatinum CompoundsProto-Oncogene Proteins B-rafProto-Oncogene Proteins p21(ras)Vascular Endothelial Growth Factor AVEGFA protein, humanFirst line therapyFOLFOXIRI BevacizumabMetastatic colorectal CancerNivolumab

Identifiers

PMID32867715
PMCPMC7457535
OpenAlexW3082484300

What OpenQuestion holds

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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.