Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

Sponsor
Institut Bergonié
Study ID
NCT05182164
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Soft-tissue Sarcoma
  • Ewing Sarcoma
  • Osteosarcoma
  • Soft Tissue Sarcoma Adult
  • Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

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

Interventions

  • Association of pembrolizumab + cabozantinib — DRUG
    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.

Study Details

Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.

Key Dates

Start date
Apr 25, 2022
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
119 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1: advanced undifferentiated pleomorphic sarcoma
    Patients with advanced undifferentiated pleomorphic sarcoma will be treated by the combination of pembrolizumab + cabozantinib
  • Experimental: Stratum 2: advanced osteosarcoma
    Patients with advanced osteosarcoma will be treated by the combination of pembrolizumab + cabozantinib
  • Experimental: Stratum 3: advanced Ewing sarcoma
    Patients with advanced Ewing sarcoma will be treated by the combination of pembrolizumab + cabozantinib

Primary Outcome Measure

Assessment of the efficacy of pembrolizumab and cabozantinib (independently for each stratum) [ Time Frame: 6 months ]

Central Contacts

Related Studies