Actively Recruiting
Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas
Led by Institut Bergonié · Updated on 2025-10-07
119
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institut Bergonié
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pembrolizumab and cabozantinib in adults with advanced sarcomas, including undifferentiated pleomorphic sarcoma, osteosarcoma, and Ewing sarcoma. This phase II trial uses three independent groups to study the effects of this drug combination on these distinct sarcoma populations. The goal is to assess how this treatment works in patients with advanced, metastatic, or recurrent disease that has progressed after standard therapy. Participants receive pembrolizumab intravenously every three weeks at a dose of 200 mg, along with daily oral cabozantinib at 40 mg. Treatment cycles last three weeks, and all three sarcoma groups receive the same combination therapy. The study is designed as a single-arm, non-randomized trial, operating independently for each sarcoma type to measure treatment response and safety. During the study, participants will have regular assessments including scans to measure tumor size, blood tests to monitor immune markers, and evaluations of overall health and side effects. Researchers will track outcomes like response to treatment, progression-free survival, overall survival, and safety over months. The main focus is on treatment effectiveness at six months, with ongoing monitoring throughout the treatment period and up to one year for some outcomes. Participation involves multiple visits for treatment and testing, with careful safety monitoring.
CONDITIONS
Brief Title
Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with undifferentiated pleomorphic sarcoma, osteosarcoma, or Ewing sarcoma
- Advanced, unresectable, or metastatic disease
- Disease recurrence or progression after standard therapy
- Documented disease progression by RECIST criteria
- Provided tumor tissue sample less than 3 months old or new biopsy
- No more than three previous systemic therapies for advanced disease
- At least 18 years old
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease outside any irradiated field, with at least one lesion 10 mm or larger
- Life expectancy greater than 3 months
- Not eligible for other approved therapies offering significant benefit
- No symptomatic central nervous system disease
- No chronic glucocorticoid use
- Adequate blood, kidney, metabolic, and liver function
- No recent or active other cancers except certain treated in situ carcinomas
- Sufficient time since last chemotherapy, immunotherapy, or radiotherapy
- Recovery from previous treatment side effects to defined levels
- Negative pregnancy test for women of childbearing potential
- Agreement to use two forms of contraception during and 6 months after treatment
- Provided voluntary informed consent
- Valid social security according to French law
You will not qualify if you...
- Prior treatment with pembrolizumab or cabozantinib
- Prior therapy with certain immune checkpoint inhibitors or related antibodies
- Progressive or symptomatic central nervous system or leptomeningeal metastases
- Not using effective contraception or pregnant/breastfeeding
- Participation in another intervention study within 21 days
- Previous enrollment in this study
- Inability to comply with study procedures
- Unable to swallow oral medication
- Known allergy to study drugs or components
- Active autoimmune disease requiring recent systemic treatment
- Immunodeficiency or recent immunosuppressive therapy
- Lung conditions including pneumonitis or fibrosis
- Active hepatitis B or C infection
- HIV infection or active tuberculosis
- Use of anticoagulants or antiplatelet agents
- Previous bone marrow or solid organ transplant
- Active infection needing systemic treatment
- Abnormal heart rhythm interval (QTcF > 500 ms)
- Chronic use of strong CYP3A4 inducers
- Recent or significant gastrointestinal bleeding or tumor invasion of critical vessels or organs
- Uncontrolled serious illnesses including cardiovascular or gastrointestinal risks
- Recent live vaccinations
- Any condition or therapy interfering with study participation
- Planned oral surgery or invasive dental procedures within or shortly after study treatment period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles, with an expected average treatment period of 6 months
Participants receive a combination of pembrolizumab administered intravenously once every 3 weeks and cabozantinib taken orally daily on a continuous basis.
Infusion visits every 3 weeks and additional visits for assessments during treatment cycles
Trial Site Locations
Total: 10 locations
1
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
2
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
3
Centre Oscar Lambret
Lille, France, 59020
Not Yet Recruiting
4
Centre Leon Berard
Lyon, France, 69008
Not Yet Recruiting
5
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
6
Hôpital La Timone
Marseille, France, 13385
Actively Recruiting
7
Institut Curie
Paris, France, 75248
Not Yet Recruiting
8
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
9
IUCT Oncopole
Toulouse, France, 31059
Not Yet Recruiting
10
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
M
Maud TOULMONDE, MD
S
Simone MATHOULIN-PELISSIER, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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