Actively Recruiting
Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Strategic Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ccRCC.
CONDITIONS
Official Title
Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic/advanced clear cell renal cell carcinoma with a clear cell component
- Received at least one prior systemic treatment including a PD-1/PD-L1 checkpoint inhibitor for advanced/metastatic disease
- Evidence of disease progression after the last treatment
- At least one measurable tumor site per RECIST 1.1 criteria
- ECOG performance status of 0, 1, or 2
- Age 18 years or older
- Adequate organ and marrow function
- INR and PT 1.5 times upper limit of normal (ULN) and PTT or aPTT 1.5 ULN unless unrelated to coagulopathy
- Participants with cardiac disease should be New York Heart Association Functional Classification class 2B or better
- Undetectable hepatitis B viral load if on suppressive therapy
- Treated and cured hepatitis C infection or undetectable viral load if on treatment
- Able to understand and willing to sign informed consent
- Women and men must agree to use adequate contraception during and for 90 days after study participation
- Female participants of childbearing potential must have a negative pregnancy test before study entry
You will not qualify if you...
- Other malignancies within the past 2 years except certain treated or low-risk cancers
- Major surgery or serious trauma within 4 weeks before enrollment or planned within 4 weeks after first dose
- Uncontrolled hypertension despite treatment
- History of bleeding disorders or significant bleeding risk within 4 weeks prior to enrollment
- Serious cardiac conditions or hospitalization for cardiac events within 12 months before enrollment
- Recent severe gastrointestinal conditions or bleeding within 6 months before enrollment
- History of recent thromboembolic events or cerebrovascular accidents within 12 months
- Symptomatic or untreated central nervous system metastases or recent CNS radiation
- Active or prior inflammatory bowel disease
- Use of other investigational agents
- Active autoimmune disease requiring systemic therapy within 2 years
- History of organ or stem cell transplantation
- Severe infection within 4 weeks prior to enrollment
- Uncontrolled pleural, pericardial effusions, or ascites causing symptoms
- Known allergy or severe hypersensitivity to ivonescimab or similar agents
- Active hepatitis C infection
- Pre-existing peripheral neuropathy grade 2 or higher
- Pregnant or breastfeeding women
- Persistent grade 2 or higher adverse events from prior therapies that interfere with study participation
- Any condition or laboratory abnormality that may interfere with study results or patient safety as judged by investigator
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
P
Pavlos Msaouel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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