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Soft Tissue Sarcoma AdultPhase 2PEMBROCABOSARCNCT05182164

Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

A Phase 2 study testing Association of pembrolizumab + cabozantinib in people with Soft Tissue Sarcoma Adult and Advanced Soft-tissue Sarcoma, run by Institut Bergonié at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Association of pembrolizumab + cabozantinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
10 sitesFrance
Study dates
25 Apr 2022to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 biopsy,
  • No more of three previous lines of systemic therapy for advanced disease,
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  • 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 cell carcinoma,
  • 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 hormone replacement) (according to NCI-CTCAE, version 5.0). For patients previously treated by radiotherapy, they must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis,
  • 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 contraception throughout the treatment period and for 6 months after discontinuation of treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year,
  • Voluntary signed and dated written informed consents prior to any specific study procedure,
  • Patients with a social security in compliance with the French Law.

Who cannot join

  • 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 targeting T-cell co-stimulation or checkpoint pathways),
  • 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 duration of the study, starting with the screening visit through 120 days after the last dose of study treatment,
  • Participation to a study involving a medical or therapeutic intervention in the last 21 days,
  • Previous enrolment in the present study,
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  • 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 form of systemic treatment and is allowed.
  • 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 active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted,
  • 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 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard,
  • 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 first dose of study treatment, Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment, The subject has radiographic evidence of cavitating pulmonary lesion(s), The subject has tumor in contact with, invading or encasing any major blood vessels, or The subject has evidence of tumor invading the GI tract, or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib.
  • 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, Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation, Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy,
  • 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 fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • 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 not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • 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 procedure within 3 months of first dose of study treatment.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maud TOULMONDE, MD contact

+33556333333

m.toulmonde@bordeaux.unicancer.fr

Simone MATHOULIN-PELISSIER, MD, PhD contact

s.mathoulin@bordeaux.unicancer.fr

10 sites in 1 country

France10 sites, 10 recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Maud TOULMONDE, MD, m.toulmonde@bordeaux.unicancer.fr

    Antoine ITALIANO, MD, PhD, a.italiano@bordeaux.unicancer.fr

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Isabelle DESMOULINS, MD, idesmoulins@cgfl.fr

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Loic LEBELLEC, MD, l-lebellec@o-lambret.fr

    Not yet recruiting

  • Centre Leon Berard

    Lyon, 69008

    Armelle DUFRESNE, MD, armelle.dufresne@lyon.unicancer.fr

    Not yet recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Francois BERTUCCI, MD, PhD, bertuccif@ipc.unicancer.fr

    Recruiting

  • Hôpital La Timone

    Marseille, 13385

    Florence DUFFAUD, MD, PhD, florence.duffaud@ap-hm.fr

    Recruiting

  • Institut Curie

    Paris, 75248

    Sarah WATSON, MD, sarah.watson@curie.fr

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest - Site René Gauducheau

    Saint-Herblain, 44805

    Emmanuelle BOMPAS, MD, emmanuelle.bompas@ico.unicancer.fr

    Recruiting

  • IUCT Oncopole

    Toulouse, 31059

    Thibaud VALENTIN, MD, valentin.thibaud@iuct-oncopole.fr

    Not yet recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Benjamin VERRET, MD, benjamin.verret@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

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

Read the 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
Being tested
Association of pembrolizumab + cabozantinib
Keywords
soft-tissue sarcoma, immune checkpoint inhibitor
Medical subject headings
Sarcoma, Ewing, Osteosarcoma, Histiocytoma, Malignant Fibrous, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Association of pembrolizumab + cabozantinibDrug

    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 groups in NCT05182164
Study groupRoleWhat they receive
Stratum 1: advanced undifferentiated pleomorphic sarcomaExperimentalPatients with advanced undifferentiated pleomorphic sarcoma will be treated by the combination of pembrolizumab + cabozantinib
Receives: Drug: Association of pembrolizumab + cabozantinib
Stratum 2: advanced osteosarcomaExperimentalPatients with advanced osteosarcoma will be treated by the combination of pembrolizumab + cabozantinib
Receives: Drug: Association of pembrolizumab + cabozantinib
Stratum 3: advanced Ewing sarcomaExperimentalPatients with advanced Ewing sarcoma will be treated by the combination of pembrolizumab + cabozantinib
Receives: Drug: Association of pembrolizumab + cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the efficacy of pembrolizumab and cabozantinib (independently for each stratum)

    Efficacy will be assessed in terms of non-progression rate at 6 months and is defined as the proportion of patients with complete response (CR), or partial response (PR), or stable disease (SD) at 6 months from the start of the treatment, based on RECIST 1.1 criteria.

    Measured: 6 months

Secondary outcomes (9)

  1. Best overall response, independently for each stratum

    Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).

    Measured: Throughout the treatment period, an expected average of 6 months

  2. 1-year progression-free survival, independently for each stratum

    Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.

    Measured: 1 year

  3. 1-year overall survival, independently for each stratum

    Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).

    Measured: 1 year

  4. Safety profile, independently for each stratum: Common Terminology Criteria for Adverse Events version 5

    Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.

    Measured: Throughout the treatment period, an expected average of 6 months

  5. 6-months non-progression rate according to iRECIST

    Efficacy will be assessed in terms of non-progression rate at 6 months and is defined as the proportion of patients with complete response (CR), or partial response (PR), or stable disease (SD) at 6 months from the start of the treatment, based on iRECIST criteria (Seymour, 2017).

    Measured: 6 months

  6. Blood cytokines levels

    Levels of cytokines in blood will be measured by ELISA.

    Measured: baseline, cycle 2 day 1, cycle 2 day 8, cycle 3 day 1, cycle 4 day 1, cycle 6 day 1 and at progression (each cycle is 21 days)

  7. Blood lymphocytes levels

    Levels of lymphocytes in blood will be measured by flow cytometry.

    Measured: baseline, cycle 2 day 1, cycle 2 day 8, cycle 3 day 1, cycle 4 day 1, cycle 6 day 1 and at progression (each cycle is 21 days)

  8. Blood kynurenine levels

    Levels of kynurenine in blood will be measured by ELISA.

    Measured: baseline, cycle 2 day 1, cycle 2 day 8, cycle 3 day 1, cycle 4 day 1, cycle 6 day 1 and at progression (each cycle is 21 days)

  9. Tumor immune cells levels

    Levels of immune cells in tumor will be measured by immunohistochemistry.

    Measured: before treatment onset and cycle 2 day 8 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start25 Apr 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
3 independent sigle-arm, multicenter, phase II trials, based on 2-stage Simon's optimal design
Masking
None (open label)
Enrolment
119 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182164
Sponsor's protocol ID
IB2020-02
Acronym
PEMBROCABOSARC
Status last verified
Oct 2025
First submitted
20 Dec 2021
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Association of pembrolizumab + cabozantinib in people with Soft Tissue Sarcoma Adult and Advanced Soft-tissue Sarcoma, run by Institut Bergonié at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maud TOULMONDE, MD (+33556333333, m.toulmonde@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the efficacy of pembrolizumab and cabozantinib (independently for each stratum) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05182164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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