20 Participants NeededMy employer runs this trial

Ivonescimab for Leiomyosarcoma

Recruiting at 6 trial locations
SD
SM
Overseen BySujana Movva, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
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 aims to determine if Ivonescimab is a safe and effective treatment for individuals with advanced leiomyosarcoma, a type of cancer that cannot be surgically removed. Participants will receive Ivonescimab through an IV every three weeks for up to two years. Those diagnosed with advanced or metastatic leiomyosarcoma who have undergone 1-3 prior treatments may be suitable for the trial. The goal is to assess whether the drug can manage the disease with few or mild side effects. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

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

The trial requires that you stop taking chemotherapy, investigational therapies, or other anti-cancer agents at least 3 weeks before starting the study drug. If you're on estrogen modulating therapies, you must stop them at least 2 weeks prior. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.

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

Research has shown that Ivonescimab has a manageable safety profile in early clinical studies, with side effects typically mild or well-controlled. In these studies, Ivonescimab also demonstrated strong anticancer effects. Additionally, safety data sheets indicate that Ivonescimab does not contain chemicals known to cause cancer or birth defects. This suggests the treatment is safe enough to continue in clinical trials. However, all treatments can have side effects, and individual experiences may vary.12345

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

Most treatments for leiomyosarcoma, such as chemotherapy with doxorubicin, work by targeting rapidly dividing cells. But Ivonescimab works differently, targeting specific proteins involved in the growth and survival of cancer cells. This unique mechanism of action could potentially lead to more effective and targeted treatment outcomes. Additionally, Ivonescimab is administered intravenously every three weeks, which may be more convenient for some patients compared to the more frequent dosing schedules of standard therapies. Researchers are excited about Ivonescimab because it offers a novel approach that could improve patient outcomes with fewer side effects.

What evidence suggests that Ivonescimab might be an effective treatment for leiomyosarcoma?

Studies have shown that Ivonescimab has promising effects against tumors, especially in patients with higher levels of the protein PD-L1, which often correlates with treatment effectiveness. Other research has found that Ivonescimab improved health outcomes and enhanced quality of life for individuals with certain lung cancers. Although specific data on leiomyosarcoma is still being gathered, these findings suggest that Ivonescimab could also be effective for this type of cancer. Researchers remain hopeful due to its success in treating other cancers.26789

Who Is on the Research Team?

SD

Sandra D'Angelo, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or metastatic leiomyosarcoma who have had 1-3 previous treatments. Participants must be able to provide a tumor sample, have measurable disease, and be in reasonably good physical condition. They need to have finished prior cancer treatments recently enough and agree to follow the study rules.

Inclusion Criteria

I have had 1 to 3 previous treatments for my LMS, or I declined first-line therapy.
I finished radiation therapy at least 2 weeks ago.
I finished cancer treatments at least 3 weeks ago and my side effects are mild or gone.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Ivonescimab is administered IV every 3 weeks on Day 1 of each cycle

up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Ivonescimab

Trial Overview

The study is testing Ivonescimab, a new drug, to see if it works and is safe for people with advanced leiomyosarcoma that can't be removed by surgery. All participants will receive Ivonescimab.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: IvonescimabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Summit Therapeutics

Industry Sponsor

Trials
18
Recruited
4,500+

Citations

A Study of Ivonescimab in People With Leiomyosarcoma

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