Trials / Active Not Recruiting
Active Not RecruitingNCT04216953
MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma
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
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- Sponsor
- Centre Leon Berard · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
The hypothesis of the proposed combination is as follows: cobimetinib via MEK1/2 inhibition could modify the tumor microenvironment and improve the response of T cells against tumor cells. Therefore, the addition of cobimetinib to atezolizumab may improve immune recognition and result in improved anti-tumour activity. The combination of cobimetinib and atezolizumab showed clinical activity in a Phase I trial in patients with metastatic colorectal cancer (Atezolizumab 840 mg every 2 weeks and Cobimetinib 60 mg/d) with a disease control rate of 31%. Atezolizumab and cobimetinib are currently being tested in pediatrics in the iMatrix clinical trial with no major safety concerns to date. A molecular screening step is mandatory for all patients enrolled in this trial in order to document MAPK pathway status and Tumor Mutational Burden (TMB) using FoundationOne test (FOne Heme).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cobimetinib | 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 |
| DRUG | Atezolizumab | 20-mL glass vial containing 1200 mg of atezolizumab. |
Timeline
- Start date
- 2020-02-12
- Primary completion
- 2026-02-01
- Completion
- 2027-02-01
- First posted
- 2020-01-03
- Last updated
- 2024-07-08
Locations
6 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04216953. Inclusion in this directory is not an endorsement.