Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial

Immunoteràpia; Sarcoma; Investigació mèdica translacional

Bibliographic Details
Authors: Grignani, Giovanni, Martínez-Trufero, Javier, Valverde Morales, Claudia Maria, Martin-Broto, Javier, Hindi, Nadia, Redondo Sanchez, Andres
Format: article
Status:Published version
Publication Date:2020
Country:España
Institution:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repository:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/6405
Online Access:https://hdl.handle.net/11351/6405
http://hdl.handle.net/11351/6405
Access Level:Open access
Keyword:Sarcoma - Tractament
Càncer - Immunoteràpia
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Connective and Soft Tissue::Sarcoma
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Immunological
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de tejido conjuntivo y de tejidos blandos::sarcoma
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::inmunoterapia antineoplásica
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oai_identifier_str oai:recercat.cat:11351/6405
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
title Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
spellingShingle Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
Grignani, Giovanni
Sarcoma - Tractament
Càncer - Immunoteràpia
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Connective and Soft Tissue::Sarcoma
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Immunological
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de tejido conjuntivo y de tejidos blandos::sarcoma
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::inmunoterapia antineoplásica
title_short Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
title_full Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
title_fullStr Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
title_full_unstemmed Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
title_sort Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial
dc.creator.none.fl_str_mv Grignani, Giovanni
Martínez-Trufero, Javier
Valverde Morales, Claudia Maria
Martin-Broto, Javier
Hindi, Nadia
Redondo Sanchez, Andres
author Grignani, Giovanni
author_facet Grignani, Giovanni
Martínez-Trufero, Javier
Valverde Morales, Claudia Maria
Martin-Broto, Javier
Hindi, Nadia
Redondo Sanchez, Andres
author_role author
author2 Martínez-Trufero, Javier
Valverde Morales, Claudia Maria
Martin-Broto, Javier
Hindi, Nadia
Redondo Sanchez, Andres
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Martin-Broto J, Hindi N] Medical Oncology Department, University Hospital Virgen del Rocio, Sevilla, Spain. Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), Sevilla, Spain. [Grignani G] Division of Medical Oncology, Candiolo Cancer Institute, FPO - IRCCS - Str. Prov.le 142, km. 3,95 - Candiolo (TO) 10060, Candiolo, Italy. [Martinez-Trufero J] Medical Oncology Department, Miguel Servet University Hospital, Zaragoza, Spain. [Redondo A] Department of Medical Oncology, Hospital Universitario La Paz, Madrid, Spain. [Valverde C] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Sarcoma - Tractament
Càncer - Immunoteràpia
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Connective and Soft Tissue::Sarcoma
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Immunological
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de tejido conjuntivo y de tejidos blandos::sarcoma
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::inmunoterapia antineoplásica
topic Sarcoma - Tractament
Càncer - Immunoteràpia
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Connective and Soft Tissue::Sarcoma
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Immunological
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de tejido conjuntivo y de tejidos blandos::sarcoma
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::inmunoterapia antineoplásica
description Immunoteràpia; Sarcoma; Investigació mèdica translacional
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/6405
http://hdl.handle.net/11351/6405
url https://hdl.handle.net/11351/6405
http://hdl.handle.net/11351/6405
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Journal for ImmunoTherapy of Cancer;8(2)
http://dx.doi.org/10.1136/jitc-2020-001561
dc.rights.none.fl_str_mv Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869421591594532864
spelling Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trialGrignani, GiovanniMartínez-Trufero, JavierValverde Morales, Claudia MariaMartin-Broto, JavierHindi, NadiaRedondo Sanchez, AndresSarcoma - TractamentCàncer - ImmunoteràpiaDISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Connective and Soft Tissue::SarcomaCHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, ImmunologicalENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de tejido conjuntivo y de tejidos blandos::sarcomaCOMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::inmunoterapia antineoplásicaImmunoteràpia; Sarcoma; Investigació mèdica translacionalInmunoterapia; Sarcoma; Investigación médica traslacionalImmunotherapy; Sarcoma; Translational medical researchBackground Sarcomas exhibit low expression of factors related to immune response, which could explain the modest activity of PD-1 inhibitors. A potential strategy to convert a cold into an inflamed microenvironment lies on a combination therapy. As tumor angiogenesis promotes immunosuppression, we designed a phase Ib/II trial to test the double inhibition of angiogenesis (sunitinib) and PD-1/PD-L1 axis (nivolumab). Methods This single-arm, phase Ib/II trial enrolled adult patients with selected subtypes of sarcoma. Phase Ib established two dose levels: level 0 with sunitinib 37.5 mg daily from day 1, plus nivolumab 3 mg/kg intravenously on day 15, and then every 2 weeks; and level −1 with sunitinib 37.5 mg on the first 14 days (induction) and then 25 mg per day plus nivolumab on the same schedule. The primary endpoint was to determine the recommended dose for phase II (phase I) and the 6-month progression-free survival rate, according to Response Evaluation Criteria in Solid Tumors 1.1 (phase II). Results From May 2017 to April 2019, 68 patients were enrolled: 16 in phase Ib and 52 in phase II. The recommended dose of sunitinib for phase II was 37.5 mg as induction and then 25 mg in combination with nivolumab. After a median follow-up of 17 months (4–26), the 6-month progression-free survival rate was 48% (95% CI 41% to 55%). The most common grade 3–4 adverse events included transaminitis (17.3%) and neutropenia (11.5%). Conclusions Sunitinib plus nivolumab is an active scheme with manageable toxicity in the treatment of selected patients with advanced soft tissue sarcoma, with almost half of patients free of progression at 6 months.This work was supported by GEIS and ISG. BMS and Pfizer provided drug supply and partial funding for shipping. Translational studies were partially funded by Beca Buesa from the GEIS group.BMJ Publishing GroupInstitut Català de la Salut[Martin-Broto J, Hindi N] Medical Oncology Department, University Hospital Virgen del Rocio, Sevilla, Spain. Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), Sevilla, Spain. [Grignani G] Division of Medical Oncology, Candiolo Cancer Institute, FPO - IRCCS - Str. Prov.le 142, km. 3,95 - Candiolo (TO) 10060, Candiolo, Italy. [Martinez-Trufero J] Medical Oncology Department, Miguel Servet University Hospital, Zaragoza, Spain. [Redondo A] Department of Medical Oncology, Hospital Universitario La Paz, Madrid, Spain. [Valverde C] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, SpainVall d'Hebron Barcelona Hospital Campus202120212020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11351/6405http://hdl.handle.net/11351/6405Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésJournal for ImmunoTherapy of Cancer;8(2)http://dx.doi.org/10.1136/jitc-2020-001561Attribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/64052026-05-29T05:05:01Z
score 15,811543

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