Cemiplimab for Secondary Angiosarcomas (NCT04873375) | Clinical Trial Compass
CompletedPhase 2
Cemiplimab for Secondary Angiosarcomas
Netherlands18 participantsStarted 2022-01-01
Plain-language summary
Secondary angiosarcomas are aggressive mesenchymal tumors with a poor prognosis and limited therapeutic options. Recent studies conducted in patients with cutaneous squamous-cell carcinoma provide evidence that cemiplimab has the potential to be an effective treatment also for patients with secondary angiosarcomas.
The purpose of this study is to evaluate the overall response rate after 24 weeks of cemiplimab treatment in patients with locally advanced or metastatic secondary angiosarcomas.
The investigators hypothesis is that cemiplimab could be an effective treatment for patients diagnosed with locally advanced and metastatic secondary angiosarcomas.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patient aged ≥ 18 years.
✓. Signed written informed consent.
✓. Histologically confirmed diagnosis of progressive unresectable locally advanced or metastatic secondary angiosarcoma.
✓. Patients in the first line of systemic treatment unfit for chemotherapy and patients in advanced lines of systemic treatment.
✓. Measurable disease per RECIST 1.1 or per physical examination / daylight photography (WHO Offset Publication No. 48) as determined by the investigator.
✓. Tumour tissue material available (archival or recent tumour biopsy).
✓. WHO ECOG 0-2.
✓. Hepatic function:
Exclusion criteria
✕. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 Diabetes mellitus, residual hypothyroidism that required only hormone therapy, or psoriasis that does not require systematic treatment.
What they're measuring
1
Overall Response Rate (ORR) after 24 weeks of cemiplimab
Timeframe: From the date of study inclusion until 24 weeks after inclusion. Interim analysis after 13 patients
✕. Prior treatment with immune checkpoint inhibitors.
✕. Continuous immunosuppressive corticosteroid treatment (doses \> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab. Note: patients who require a brief course of steroids (e.g. as prophylaxis for imaging studies) are not excluded.
✕. Active uncontrolled infection requiring therapy, including infection with HIV, active infection with HBV or HCV.
✕. History of pneumonitis within the last 5 years.
✕. Untreated brain metastasis(es) that may be considered active.
✕. Patients with allergy or hypersensitivity to cemiplimab or to any of the excipients must be excluded. Specifically, because of the presence of trace components in cemiplimab, patients with allergy or hypersensitivity to doxycycline or tetracycline are excluded.
✕. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments