Actively Recruiting
Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-04-20
24
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.
CONDITIONS
Official Title
Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign informed consent before starting the study
- Age 18 years or older
- Has locally advanced, unresectable, or metastatic cutaneous squamous cell carcinoma (Cohort 1)
- Has metastatic castration-resistant prostate cancer confirmed by biopsy and progression documented by PSA levels (Cohort 2)
- Surgically or medically castrated with serum testosterone level below 50 ng/dL (Cohort 2)
- Refractory or naive to anti-PD-1 therapy (Cohort 1) with no limit on prior therapy lines
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease per appropriate criteria for skin cancer (Cohort 1)
- Adequate organ and marrow function within 28 days before starting treatment
- Adequate washout from prior therapies as specified
- Prior anti-VEGF therapy allowed (Cohort 1)
- Controlled blood pressure with 0 or 1 antihypertensive medication
- Negative pregnancy test within 72 hours before treatment for women of childbearing potential
- Agree to use adequate contraception during and up to 120 days after treatment for women of childbearing potential and men of childbearing potential
You will not qualify if you...
- Previous treatment with PD-1/PD-L1 inhibitors requiring permanent discontinuation or systemic immunosuppression due to immune-related adverse events
- History of allergic reactions to ivonescimab or similar compounds
- Pregnant or breastfeeding
- Active known or suspected autoimmune disease, except certain controlled conditions
- Known HIV/AIDS infection
- Known acute or chronic hepatitis B or C infection
- Previous solid organ or allogeneic stem cell transplant
- Active infection requiring IV antibiotics or uncontrolled illness needing hospitalization
- Unresolved or irreversible toxicities from prior therapy except specified exceptions
- Major blood vessel invasion
- Major surgery or serious trauma within 4 weeks before treatment or planned within 4 weeks after
- Unstable heart conditions or recent serious cardiac events within 12 months
- Recent severe gastrointestinal conditions within 6 months
- Recent serious thromboembolic or cerebrovascular events within 6 months
- Recent acute exacerbation of chronic obstructive pulmonary disease within 4 weeks
- History of gastrointestinal tract perforation, obstruction, or extensive bowel surgery within 6 months
- Treatment with live attenuated vaccine within 4 weeks before treatment or planned during study
- Additional progressing malignancies requiring active treatment except certain skin and cervical cancers
- Psychiatric or substance abuse disorders interfering with study cooperation
- Inability to comply with study and follow-up procedures
- Receiving other investigational agents
- Psychiatric or social conditions limiting compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Aung Naing, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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