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
292 weeks
Total Duration
On this page
Sponsors
I
Institut Bergonié
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.
CONDITIONS
Official Title
Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of undifferentiated pleomorphic sarcoma, osteosarcoma, or Ewing sarcoma
- Advanced, unresectable or metastatic disease
- Disease recurrence or progression after standard therapy
- Documented progression based on RECIST criteria
- Availability of tumor tissue sample obtained within 3 months or newly collected
- No more than three prior systemic therapies for advanced disease
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status 0 or 1
- Measurable disease outside previously irradiated areas with at least one lesion 10 mm
- Life expectancy greater than 3 months
- Advanced disease with no other approved beneficial therapeutic options
- No symptomatic central nervous system disease
- No chronic glucocorticoid use
- Adequate blood, kidney, metabolic, and liver function
- No prior or concurrent malignant disease treated in last 2 years except specific in situ carcinomas
- At least 3 weeks since last chemotherapy or immunotherapy, 2 weeks since other treatments
- Recovery to grade 1 from prior treatment side effects (with specific exceptions)
- Negative pregnancy test for women of childbearing potential within 72 hours before treatment
- Agreement to use two medically acceptable contraception methods during and 6 months after treatment
- Signed informed consent
- Have social security compliant with French law
You will not qualify if you...
- Prior treatment with pembrolizumab or cabozantinib
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
- Progressive or symptomatic central nervous system or leptomeningeal metastases
- Childbearing potential without effective contraception, pregnancy, breastfeeding, or planning pregnancy during study
- Participation in another interventional study within last 21 days
- Prior enrollment in this study
- Unable to follow study procedures due to personal reasons
- Unable to swallow
- Known hypersensitivity to study drugs or components
- Active autoimmune disease requiring systemic treatment in past 2 years (except replacement therapy)
- Immunodeficiency or recent immunosuppressive therapy within 7 days before treatment
- History or evidence of certain lung diseases or active pneumonitis
- Known active Hepatitis B, Hepatitis C, HIV, or active tuberculosis
- Treatment with anticoagulants or antiplatelet agents
- Prior allogenic bone marrow or solid organ transplantation
- Active infection requiring systemic treatment at study entry
- Prolonged corrected QT interval above 500 ms
- Chronic treatment with strong CYP3A4 inducers
- Significant recent gastrointestinal bleeding or pulmonary hemorrhage
- Tumor involvement of major blood vessels or gastrointestinal tract
- Uncontrolled serious illnesses including cardiovascular or gastrointestinal disorders
- Live vaccine within 30 days before treatment
- Any condition or therapy that may interfere with study results or participation
- Planned or recent oral surgery or invasive dental procedures within specified timeframes
AI-Screening
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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
CONTACT
S
Simone MATHOULIN-PELISSIER, MD, PhD
CONTACT
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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