COTESARC : A multicentre, open-label, Phase I-II study evaluating the combination of a MEK inhibitor and a PDL1 inhibitor in pediatric and adult patients with locally advanced and/or metastatic soft tissue sarcoma

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510712-75-00

Acronym

ET-19036

Enrollment

Registered

2024-12-04

Start date

2020-02-12

Completion date

Unknown

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced / metastatic

Brief summary

Safety run in Incidence of severe toxicities (ST) during the 1st cycle of treatment, Phase II part Progression Free rate after 16 weeks of treatment (PFR16w)

Detailed description

Nature, frequency and severity of AE according to NCI-CTCAE V5.0, ORR at 8 and 16 weeks according to RECIST V1.1 and iRECIST Duration of response; PFS; OS

Interventions

DRUGCOBIMETINIB

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGCotellic 20 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety run in Incidence of severe toxicities (ST) during the 1st cycle of treatment, Phase II part Progression Free rate after 16 weeks of treatment (PFR16w)	—

Secondary

Measure	Time frame
Nature, frequency and severity of AE according to NCI-CTCAE V5.0, ORR at 8 and 16 weeks according to RECIST V1.1 and iRECIST Duration of response; PFS; OS	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026