ImmunoSarc 2
Research type
Research Study
Full title
Phase I-II trial of sunitinib and/or nivolumab plus chemotherapy in advanced soft tissue and bone sarcomas
IRAS ID
276789
Contact name
Sandra Strauss
Contact email
Sponsor organisation
Grupo Español de Investigación en Sarcomas (GEIS)
Eudract number
2016-004040-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 7 months, 1 days
Research summary
Sarcomas are rare, aggressive, malignant tumours that affect soft tissues and bones, and patients of all ages including children, teenagers and young adults (TYA). Sarcomas are very heterogeneous (with more than 100 subtypes), many of which currently lack effective therapies. Surgery and intensive chemotherapy are the only available options for treatment. For patients with metastatic disease, there is no curative treatment. In view of this, new therapeutic approaches are urgently needed.
The ImmunoSARC trial, commenced in 2016, sought to investigate the role of immune modulation in sarcoma, by evaluating the safety and efficacy of sunitinib, given in combination with nivolumab. Phase I study conducted across Spain and Italy demonstrated this combination to be safe, and a preliminary phase 2 study met its primary endpoint with sunitinib and nivolumab being shown to be an active combination for the treatment of advanced selected soft tissue sarcomas, with 50% of patients free of progression at 6 months.
ImmunoSARC-2 is an extension of the original study focusing on the selected subtypes of sarcoma that showed most promise in the initial study. The trial is a phase I/II, multi-arm, eight-cohort, non-randomized, open-label, multicentre prospective study. Protocol V11.0 introduced two additional cohorts of Nivolumab and chemotherapy combination. It is an international study with sites in Spain, Italy and UK, with a recruitment period until January 2025. Cohort 7 and Cohort 8 will not open or recruit in the UK, only the current Cohorts (Cohort 1-6) will recruit.Cohort 1-6:
Treatment – induction phase;
Adults - Sunitinib 37.5 mg/day orally continuously
Paediatric patients (<18 years) - sunitinib will be given at 25 mg/day unless the body surface area (BSA) of the patient is >1.7. If BSA is >1.7, then sunitinib 37.5 mg/day will be given.
Treatment – maintenance phase;
Adults - Sunitinib 25 mg/day orally continuously + nivolumab 240 mg every 2 weeks regimen infused over 30 minutes
Paediatric patients - 25 mg/day orally continuously + nivolumab 240 mg every 2 weeks regimen infused over 30 minutes.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0978
Date of REC Opinion
10 Dec 2020
REC opinion
Further Information Favourable Opinion