10 Participants NeededMy employer runs this trial

Ivonescimab for Skin Cancer

MN
Overseen ByMichael Nakazawa, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: Taxane-based chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ivonescimab, a new treatment for advanced skin cancer known as cutaneous angiosarcoma. The researchers aim to determine if ivonescimab is effective and safe for patients whose cancer has spread or cannot be removed and who have already tried taxane-based chemotherapy. Individuals diagnosed with this cancer type and previously treated with paclitaxel or docetaxel might be suitable for this study. Participants will receive the treatment every three weeks until there is a reason to stop, such as disease progression or side effects. As a Phase 2 trial, this study measures how well ivonescimab works in an initial, smaller group of people, offering participants a chance to contribute to important research.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not be on certain treatments like chemotherapy or radiotherapy within 4 weeks before starting the trial, and you should not be using systemic corticosteroids above a certain dose. 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 safe. Most patients tolerated the treatment well without severe side effects. Some studies noted blood-related issues, but these were usually manageable. In a few cases, patients experienced serious side effects, though these were uncommon. Overall, ivonescimab has a promising safety record, with no new safety concerns identified in recent trials.12345

Why do researchers think this study treatment might be promising for skin cancer?

Unlike the standard treatments for skin cancer, which typically involve surgery, radiation, or chemotherapy, Ivonescimab offers a novel approach by acting as a targeted immunotherapy. Ivonescimab works by blocking specific proteins that cancer cells use to evade the immune system, thereby enhancing the body's natural ability to fight cancer. This mechanism not only provides a more targeted attack on cancer cells but also aims to reduce the side effects commonly associated with traditional treatments. Researchers are excited about Ivonescimab because it holds the potential for improved effectiveness and tolerability, offering new hope for individuals battling skin cancer.

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

Research has shown that ivonescimab holds promise in fighting tumors, particularly in patients with elevated levels of the protein PD-L1. Studies have found that ivonescimab significantly slows tumor growth in skin cancer and outperforms pembrolizumab, a common cancer drug, in delaying cancer progression. In other cancers, such as non-small cell lung cancer, ivonescimab improved patient response to treatment and helped control the disease. This treatment targets two proteins, PD-1 and VEGF-A, which play roles in cancer growth, indicating its potential usefulness in treating various cancers. These findings suggest ivonescimab might be effective for advanced skin cancers. Participants in this trial will receive ivonescimab to further evaluate its effectiveness in treating skin cancer.23678

Who Is on the Research Team?

MN

Michael Nakazawa, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or metastatic skin angiosarcoma who have already tried taxane chemotherapy. Participants must have good organ function, measurable disease, and be able to use effective birth control. People with certain infections, heart issues, autoimmune diseases, recent major surgery, or prior immune therapy cannot join.

Inclusion Criteria

My hepatitis B is well-controlled with undetectable or stable viral load on treatment.
I have previously received paclitaxel or docetaxel treatment.
I have a tumor that can be measured by scans or exams within the last month.
See 13 more

Exclusion Criteria

I do not have severe side effects from previous cancer treatments, except hair loss.
Receiving other investigational agents
Psychiatric or social conditions limiting compliance
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ivonescimab (20 mg/kg IV on Day 1 Q3W) until progressive disease or other discontinuation criteria are met

6 months
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ivonescimab

Trial Overview

The study is testing ivonescimab—a new antibody treatment—for safety and effectiveness in people with advanced cutaneous angiosarcoma. All participants receive the drug; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment with IvonescimabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Ivonescimab for Skin Cancer

ivonescimab significantly reduced tumor growth. It also outperformed the current drug pembrolizumab in delaying cancer progression,

Efficacy and safety of ivonescimab in non-small cell lung ...

5 studies comprising. AK112-based regimens significantly improved ORR (OR = 1.65, 95% CI: 1.31–2.09) and DCR (OR = 2.29, 95% CI: 1.18–4.44) compared to control ...

Efficacy and Safety of Ivonescimab in the Treatment of ... - PMC

Ivonescimab showed promising antitumor activity and improved clinical outcomes, particularly in patients with higher PD-L1 expression levels

Ivonescimab Improves Survival in Advanced Squamous ...

New data show that with a median follow-up of 21.4 months, the median OS was 27.9 months with ivonescimab compared with 23.7 months for ...

Cadonilimab or ivonescimab plus axitinib in metastatic ...

Results: As of December 25, 2025, a total of 28 patients have been enrolled in the study (14 cohort 1; 14 cohort 2). Median follow-up of 13 ...

Efficacy and safety of ivonescimab in non-small cell lung cancer

The safety profile of AK112 was generally manageable, with hematologic toxicities representing the most common adverse events, particularly when combined with ...

Ivonescimab – Application in Therapy and Current Clinical ...

This article summarizes the ongoing clinical trials investigating the efficacy and safety of Ivonescimab, either alone or in combination with other treatments, ...

HARMONi-6: Evaluating the Safety and Generalizability of ...

While ivonescimab led to numerically more grade 3 adverse effects, most VEGF-related toxicities were low-grade, treatment discontinuation rates ...