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New treatment option for Soft Tissue Sarcoma Adult
Official title Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas
ClinicalTrials.gov ID: NCT05182164
What this study is testing
What is Association of pembrolizumab + cabozantinib?
Association of pembrolizumab + cabozantinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for soft tissue sarcoma adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histology: undifferentiated pleomorphic sarcoma (stratum 1), bone osteosarcoma (stratum 2), bone or extraskeletal or Ewing sarcoma (stratum 3),
- Advanced non resectable / metastatic disease,
- Recurrent disease or progression after standard therapy,
- Documented progression according to RECIST criteria.
- Have provided tissue of a tumor lesion from \< 3 months old archival tissue sample obtained on locally advanced disease, or metastatis with no...
You likely can't join if
- Previous treatment with Pembrolizumab or Cabozantinib,
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4)...
- Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,
- Men or women of childbearing potential who are not using an effective method of contraception; women who are pregnant or breast feeding, men or women...
- Participation to a study involving a medical or therapeutic intervention in the last 21 days,
- Previous enrolment in the present study,
See the full eligibility criteria
Who can join
- Histology: undifferentiated pleomorphic sarcoma (stratum 1), bone osteosarcoma (stratum 2), bone or extraskeletal or Ewing sarcoma (stratum 3),
- Advanced non resectable / metastatic disease,
- Recurrent disease or progression after standard therapy,
- Documented progression according to RECIST criteria.
- Have provided tissue of a tumor lesion from \< 3 months old archival tissue sample obtained on locally advanced disease, or metastatis with no subsequent treatment since or from a newly obtained core or excisional...
- No more of three previous lines of systemic therapy for advanced disease,
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group ≤ 1,
- Measurable disease according to RECIST v1.1 outside any previously irradiated field. At least one site of disease must be uni-dimensionally ≥ 10 mm,
- Life expectancy \> 3 months,
- Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgement,
- No symptomatic central nervous system disease,
- No chronic use of glucocorticoids.
- Adequate hematological, renal, metabolic and hepatic function,
- No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder...
- At least three weeks since last chemotherapy, immunotherapy and two weeks for any other pharmacological treatment and/or radiotherapy,
- Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia of any grade, non-painful peripheral neuropathy grade ≤ 2 and endocrine-related grade ≤ 2 requiring treatment or...
- Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Both women and men must agree to use 2 medically acceptable methods of...
- Voluntary signed and dated written informed consents prior to any specific study procedure,
- Patients with a social security in compliance with the French Law.
What rules you out
- Previous treatment with Pembrolizumab or Cabozantinib,
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumabor any other antibody or drug specifically...
- Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,
- Men or women of childbearing potential who are not using an effective method of contraception; women who are pregnant or breast feeding, men or women who are planning to conceive or father children within the projected...
- Participation to a study involving a medical or therapeutic intervention in the last 21 days,
- Previous enrolment in the present study,
- Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,
- Patient unable to swallow,
- Known hypersensitivity to any involved study drug or of its formulation components,
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy is not considered a...
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment,
- History of idiopathic pulmonary fibrosis, history of non-infectious pneumonitis that required steroids, current pneumonitis/interstitial lung disease, drug-induced pneumonitis, organizing pneumonia, or evidence of...
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Has a known history of HIV infection and/or of active TB (Bacillus Tuberculosis),
- Treatment with anticoagulants such as anti-Vitamin K, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel),
- Previous allogenic bone marrow transplant or solid organ transplantation,
- Has an active infection requiring systemic treatment at study entry,
- The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 28 days before treatment. Note: if initial QTcF is found to be \> 500 ms, two additional ECGs separated by at least 3...
- The subject requires chronic concomitant treatment of strong CYP3A4 inducers
- The subject has experienced any of the following: Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment, Hemoptysis of ≥ 2.5 mL of red blood within 3 months before the...
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions which are fully described in the study protocol: Cardiovascular disorders...
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Has an history or current evidence of any condition, therapy, or laboratory abnormality that might counfound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- The subject is planning to have oral surgery/invasive dental procedure within the projected duration of the study, starting with the screening visit through 3 months after the last dose of study treatment or had such a...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Dijon, France
- Lille, France
- Lyon, France
- Marseille, France
- Paris, France
- Saint-Herblain, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Dijon, France; Lille, France; Lyon, France; Marseille, France; Paris, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.