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Monoclonal Antibodies

Ivonescimab for Skin Cancer

Phase 2

Recruiting

Led By Aung Naing, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequately controlled blood pressure with 0 or 1 antihypertensive medication

Must not have

Participants who have previously been treated with PD-1 inhibitors and required dose interruption, permanent discontinuation, or systemic immunosuppression due to irAEs

Known history of acute or chronic hepatitis B virus or hepatitis C virus infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if ivonescimab can effectively manage advanced cSCC. It will also assess the safety and impact of ivonescimab on patients."

Who is the study for?

This trial is for adults over 18 with advanced skin cancer (cSCC) that can't be removed or has spread, and who didn't respond to anti-PD-1 therapy. They should have a life expectancy of at least 3 months, manageable blood pressure on up to one medication, and agree to use contraception. People with certain medical conditions, previous severe reactions to PD-1 inhibitors, active infections requiring IV antibiotics, or uncontrolled illnesses are excluded.

What is being tested?

The study tests ivonescimab's ability to control advanced cutaneous Squamous Cell Carcinoma (cSCC). It will assess the safety and effects of this drug in patients who haven't responded well to other treatments like anti-PD-1 therapy.

What are the potential side effects?

While specific side effects of ivonescimab aren’t detailed here, similar drugs often cause immune-related adverse events such as inflammation in organs, fatigue, digestive issues; allergic reactions are possible too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My blood pressure is controlled with up to one medication.

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I am 18 years old or older.

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My skin cancer cannot be removed with surgery and may have spread.

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I have completed all previous cancer treatments before starting this study.

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My condition did not improve after anti-PD-1 therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had to stop or pause PD-1 inhibitor treatment due to side effects.

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I have a history of hepatitis B or C.

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I have had a transplant of an organ or stem cells from a donor.

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I do not have an active infection needing IV antibiotics or any severe illness requiring hospitalization.

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I have tested positive for HIV/AIDS.

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I have not received a live vaccine in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IvonescimabExperimental Treatment1 Intervention

Participants found to be eligible to take part in this study, you will receive ivonescimab by vein over about 1-2 hours on Day 1 of each 21-day cycle (1 time every 3 weeks).

0 / 12Eligibility criteria met