MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma

Sponsor
Centre Leon Berard
Study ID
NCT04216953
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Sarcoma,Soft Tissue

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cobimetinib — DRUG
    Adults: 20mg film coated tablet Paediatrics: i) powder for oral suspension containing 250mg of cobimetinib ii) for pediatric patients ≥12 years-old and with a BW ≥60kg : 20mg film coated tablet same as adults
  • Atezolizumab — DRUG
    20-mL glass vial containing 1200 mg of atezolizumab.

Study Details

The proposed study conducted in adult and pediatric patients aims to evaluate the safety and clinical activity of atezolizumab + cobimetinib in advanced/metastatic soft tissue sarcomas (up to 80 patients).

Key Dates

Start date
Feb 12, 2020
Status verified
Apr 2026
Primary completion
Dec 1, 2024
Completion
Mar 17, 2025

Study Design

Enrollment
229 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Cobimetinib
    Atezolimumab : * Adult Patient and patients ≥12 years-old with a BW ≥60kg: 840mg, Q2W * Pediatric Patient including patients ≥12 years-old with a BW \<60kg: 15mg/kg, Q2W with a maximum of 840mg. Cobimetinib : * Pediatric patients ≥ 12 and a BW \< 60kg:1mg/kg. Pediatric patients ≥ 12 and with a BW ≥ 60kg: 60mg/d. * Adult Patients: 60mg/d D1 to D21 over a 28-day cycle.

Primary Outcome Measure

Phase II part [ Time Frame: 16 weeks ]

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