Ivonescimab for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Anticoagulants, Corticosteroids

Disqualifiers: Hypertension, Autoimmune, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of ivonescimab, an immunotherapy drug, in shrinking tumors in patients with high-risk clear cell kidney cancer before surgery. The drug aids the immune system in attacking cancer and may prevent tumor growth by blocking blood vessel development. This study suits those with high-risk localized clear cell kidney cancer who are candidates for tumor removal surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants the chance to contribute to significant advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), they must be stable before you enroll. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ivonescimab is likely to be safe for humans?

Research has shown that ivonescimab is generally well-tolerated by patients with advanced solid tumors. In studies, most patients experienced manageable side effects, meaning they were not severe. It is important to note that this treatment remains under investigation, so not all potential risks are known. However, current evidence suggests that ivonescimab could be a safe option for treating kidney cancer before surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney cancer, which typically involve surgery, chemotherapy, or targeted therapies, ivonescimab acts on a different mechanism. It is a novel antibody designed to target specific proteins involved in tumor growth, potentially offering a more targeted attack on cancer cells. Researchers are excited about ivonescimab because it may reduce tumor size before surgery, potentially making it easier to remove the cancer. Additionally, its administration as an intravenous infusion allows for precise control over dosing, which could minimize side effects compared to traditional chemotherapies.

What evidence suggests that ivonescimab might be an effective treatment for kidney cancer?

Research has shown that ivonescimab, the treatment under study in this trial, may combat kidney cancer by attacking cancer cells and inhibiting the growth of blood vessels that tumors require. In studies with patients who had advanced kidney cancer, ivonescimab appeared promising, particularly for those who had already tried other immune treatments. This indicates that ivonescimab could help shrink tumors before surgery. It has also demonstrated better results than some other treatments in certain cancers, such as lung cancer, suggesting it might be effective against kidney cancer as well. While more information is needed, early findings indicate that ivonescimab could be a powerful option for treating kidney cancer that hasn't spread. ^{3 5 6 7 8}

Who Is on the Research Team?

Wesley Yip

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with high-risk localized clear cell renal cell cancer that hasn't spread. Participants should be candidates for surgery and have no prior treatments for kidney cancer.

Inclusion Criteria

Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Specific blood count requirements: ANC ≥ 1.5 × 10^9/L, Platelet count ≥ 100 × 10^9/L, Hemoglobin ≥ 9.0 g/dL

My kidney cancer is confirmed to be clear cell type.

Exclusion Criteria

History of major diseases affecting safety evaluation

Known allergy to study drug components or severe hypersensitivity to monoclonal antibodies

History of severe immune-mediated adverse events from immunotherapy agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive ivonescimab intravenously every 3 weeks for 4 cycles

12 weeks

4 visits (in-person)

Surgery

Participants undergo standard of care nephrectomy

4-10 weeks after treatment

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 12 weeks for 2 years, then periodically

What Are the Treatments Tested in This Trial?

Interventions

• Ivonescimab

Trial Overview

The study tests ivonescimab, a monoclonal antibody, given before surgery to see if it can shrink kidney tumors by boosting the immune system and blocking new blood vessel growth.

How Is the Trial Designed?

Group I: Treatment (ivonescimab) Experimental Treatment 7 Interventions

Patients receive ivonescimab IV over 60-120 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Between 4-10 weeks after completion of ivonescimab treatment, patients then undergo SOC nephrectomy. Patients also undergo ECHO during screening, biopsy prior to treatment start, and CT and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12509606/

20: Phase II trial of ivonescimab in patients with advanced ...

20: Phase II trial of ivonescimab in patients with advanced clear cell renal cell carcinoma previously treated with immune checkpoint blockade: ...

2.

cancernetwork.com

cancernetwork.com/view/ivonescimab-displays-preclinical-feasibility-in-frontline-ccrcc

Ivonescimab Displays Preclinical Feasibility in Frontline ...

The investigational agent exhibited superior efficacy vs pembrolizumab in patients with lung cancer, suggesting potential efficacy in kidney ...

3.

urotoday.com

urotoday.com/clinical-trials/kidney-renal-cancer/163689-phase-ii-trial-of-ivonescimab-in-previously-treated-patients-with-advanced-clear-cell-renal-cell-carcinoma.html

Phase II Trial of Ivonescimab in Previously Treated Patients ...

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

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06683846?tab=table

Ivonescimab in the Treatment of Multiple Advanced Tumors

The goal of this clinical trial is to learn if Ivonescimab works to treat advanced rare tumors including cohort 1: PAGET's disease of scrotum with infiltrating ...

5.

kcrs.kidneycan.org

kcrs.kidneycan.org/wp-content/uploads/2025/07/KCRS25-Abstract-Book-7.14.25.pdf

KCRS25

20 Phase II trial of ivonescimab in patients with advanced clear cell renal cell carcinoma previously treated with immune checkpoint ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11925807/

Safety, Pharmacokinetics, and Pharmacodynamics Evaluation ...

We report the safety, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of ivonescimab in patients suffered from advanced solid tumors.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07226544

Ivonescimab Prior to Surgery for the Treatment of High ...

This phase II trial studies how well ivonescimab works prior to surgery in treating patients with high-risk clear cell kidney (renal cell) ...

8.

cancernetwork.com

cancernetwork.com/view/ivonescimab-shows-dual-inhibition-of-vegf-and-pd-1-pathways-in-ccrcc

Ivonescimab Shows Dual Inhibition of VEGF and PD-1 ...

Treatment with the dual inhibitor displayed a short half-life and a manageable toxicity profile in patients with clear cell renal cell carcinoma ...