Trials / Recruiting
RecruitingNCT05182164
Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 119 (estimated)
- Sponsor
- Institut Bergonié · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.
Detailed description
3 independent, multicenter, prospective, signel-arm phase II trial, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of pembrolizumab + cabozantinib, in distinct populations of sarcomas: * stratum 1: advanced undiffenrentiated pleomorphic sarcoma * stratum 2: advanced osteosarcoma * stratum 3: advanced ewing sarcoma
Conditions
- Soft Tissue Sarcoma Adult
- Advanced Soft-tissue Sarcoma
- Ewing Sarcoma
- Osteosarcoma
- Undifferentiated Pleomorphic Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Association of pembrolizumab + cabozantinib | A treatment cycle consists of 3 weeks. Pembrolizumab will be administered intraveinously on day 1 every 3 weeks (200 mg). Cabozantinib will be administered per os, once daily (40 mg), and given on a continuous basis. |
Timeline
- Start date
- 2022-04-25
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2022-01-10
- Last updated
- 2025-10-07
Locations
10 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05182164. Inclusion in this directory is not an endorsement.