Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
Immunotherapy has gained a significant amount of attention recently, but its efficacy as a single agent in gynecological cancers has been disappointing. Pre-clinical evidence supports the combination of using Vascular Endothelial Growth Factors (VEGF) inhibitors with immunotherapy. VEGF inhibitors suppress the activation of tumor-associated macrophages (TAMs) and VEGF has been shown to affect the functional maturation of dendritic cells; therefore, VEGF inhibitors could improve the function of antigen presentation. In this study, Cabozantinib (VEGF inhibitor) and Dostarlimab (immunotherapeutic drug) will be admnistered as a combination to patients with recurrent gynecologic carcinosarcoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis of carcinosarcoma (independent of organ of gynecologic origin)
Received at least one prior chemotherapy regimen for their cancer
Must have measurable or evaluable lesion defined by iRECIST
Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy
Disqualifiers
Prior treatment with cabozantinib.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives (whichever is longer) before first dose of study treatment.
Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Trial design
Design model
Single group
Treatments tested in this trial
Cabo + Dostarlimab
DrugCombination of standard dose of cabozantinib and 500 mg dostarlimab for first 4 cycles followed by standard dose of cabozantinib and 1000 mg of dostarlimab until 2 years of treatment
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Cabo + DostarlimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival at 6 months
To estimate the proportion of patients with recurrent carcinosarcoma-who survive progression-free for at least 6 months from the start of treatment-treated with cabozantinib + dostarlimab in the second line setting and beyond (per imaging Response Evaluation Criteria in Solid Tumours).
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov