Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

May 31, 2017

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2024

Conditions
Soft Tissue SarcomaBone Sarcoma
Interventions
DRUG

Sunitinib 37.5 MG, Sunitinib 25 MG [Sutent]

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

DRUG

Nivolumab 100 MG/10 ML [Opdivo]

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

DRUG

Epirubicin

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

DRUG

Ifosfamide

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

DRUG

Doxorubicin

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

DRUG

Dacarbazine

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

DRUG

Cisplatin

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

DRUG

Methotrexate

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

Trial Locations (13)

10060

Candiolo Cancer Institute - FPO, IRCCS, Candiolo

20133

Istituto Nazionale dei Tumori, Milan

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

38320

Complejo Hospitalario Universitario de Canarias, San Cristóbal de La Laguna

40136

Istituto Ortopedico Rizzoli, Bologna

41013

Hospital Universitario Virgen del Rocío, Seville

46026

Hospital Universitari i Politècnic La Fe, Valencia

50009

Hospital Universitario Miguel Servet, Zaragoza

08035

Hospital Universitari Vall d'Hebrón, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

NW1 2PG

University College London Hospitals NHS Foundation Trust, London

All Listed Sponsors
lead

Grupo Espanol de Investigacion en Sarcomas

OTHER

NCT03277924 - Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas | Biotech Hunter | Biotech Hunter