Pilot Study of Ivonescimab in Advanced/Metastatic Cutaneous Angiosarcoma
ConditionCutaneous Angiosarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
This is a pilot study evaluating the efficacy and safety of ivonescimab in subjects with advanced or metastatic cutaneous angiosarcoma who have previously been treated with taxane-based chemotherapy.
Eligibility criteria
Qualifiers
Patients must have histologically confirmed cutaneous angiosarcoma that is advanced, metastatic or unresectable.
Patients must have received prior paclitaxel or docetaxel containing therapy.
Patients must have measurable disease within 28 days of starting treatment, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, PET or calipers by clinical exam/medical photography.
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ivonescimab in patients <18 years of age, children are excluded from this study.
Disqualifiers
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
Patients who have not recovered from adverse events due to prior anti-cancer therapy (residual toxicities that are > Grade 2 by CTCAE v 5.0) with the exception of alopecia.
Patients who are receiving any other investigational agents.
Patients who have received prior immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 drugs).
Trial design
Treatments tested in this trial
- Ivonescimab
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov