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Phase II Trial of Ivonescimab for Advanced Clear Cell Renal Cell Carcinoma

This study is testing a drug called ivonescimab for people with advanced clear cell renal cell carcinoma (a type of kidney cancer) that has already been treated with other medicines. The goal is to see if ivonescimab can help control the cancer and how safe it is. You might be able to join if you are 18 or older, have clear cell renal cell carcinoma that has spread, and have already received at least one prior treatment, including a PD-1/PD-L1 checkpoint inhibitor. Researchers will be looking at how many people respond to the treatment and how long the disease is kept under control. The study plans to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06940518

Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Ivonescimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events
Measured over Through study completion; an average of 1 year.

Conditions

Ivonescimab
Clear Cell Renal Carcinoma

Explore related trials

Clear Cell Renal Cell Carcinoma

NCT06940518

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pavlos Msaouel, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Pavlos Msaouel, MD
[email protected]
713-563-4585
Email the study team

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Eligibility criteria

Inclusion

Ability to understand and the willingness to sign a written informed consent document for this clinical trial and the companion Trials LAB02-152 and PA17-0577

Exclusion

Nasal bleeding /epistaxis. Bloody nasal discharge is allowed.
Hematuria associated with urinary obstruction. Microhematuria or macrohematuria not associated with urinary obstruction are allowed.
Radiologically documented evidence of major blood vessel encasement with narrowing of the vessel that the investigator determines will pose a significantly increased risk of bleeding. 5. History of major diseases prior to enrollment, specifically:
Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] classification . grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)
History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to enrollment. 6. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment.
Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to enrollment.
History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment. 7. Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrolmment, or potential need for CNS radiation within the first cycle of ivonescimab.
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.
Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted. 11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 12. Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, severe sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B or C). 13. Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic. Participants managed with indwelling catheters (e.g., PleurX) are allowed. 14. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab or other agents used in study. This includes known history of severe hypersensitivity to other monoclonal antibodies. 15. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 16. Participants with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment. All patients with active hepatitis C (hepatitis C virus \[HCV\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded. 17. Pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5.0. 18. Pregnant women are excluded from this study because ivonescimab is a bispecific agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ivonescimab, breastfeeding should be discontinued if the mother is treated with ivonescimab.

What this trial measures

  • Safety and adverse eventsThrough study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version