Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma
ConditionCutaneous Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Age ≥18 years.
Has locally advanced surgically non-appropriate (unresectable and/or metastatic) cSCC (Cohort 1)..
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
Disqualifiers
Patients who have previously been treated with PD-1/PD-L1 inhibitors and required permanent discontinuation, or systemic immunosuppression due to irAEs.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab.
Pregnant or breastfeeding.
Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Trial design
Design model
Single group
Treatments tested in this trial
Ivonescimab
DrugGiven by PO
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: IvonescimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Summit Therapeutics
Collaborator
Source ClinicalTrials.gov