Study on Ivonescimab for Treating Thymic Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT06980077

This clinical trial is exploring how well the drug ivonescimab works in treating patients with thymic carcinoma, a type of cancer. Ivonescimab is an immunotherapy that may help the immune system attack cancer cells and stop them from growing and spreading.

Patient Parameters

Program Overview

The purpose of this study is to test the effectiveness of ivonescimab in treating thymic carcinoma, a cancer that affects the thymus gland. The study will measure how well the drug works by looking at how many patients experience a reduction in their cancer. It will also assess the safety of the drug and how well patients tolerate it. Researchers will also look at how long patients live without the cancer getting worse and how long the treatment effects last. Additionally, the study will explore potential markers in blood and tissue samples that might predict how well patients respond to the treatment.

Description

In this study, patients will receive ivonescimab through an IV infusion over 60 to 120 minutes on the first day of each treatment cycle. These cycles will repeat every three weeks for up to two years, as long as the cancer does not progress and the treatment is well-tolerated. Throughout the study, patients will have CT scans and provide blood and urine samples. Some patients may also have MRI scans and optional biopsies at the end of the treatment. After finishing the treatment, patients will have follow-up visits every six weeks for the first 24 weeks, and then every 12 weeks for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide informed consent.
  • Have a confirmed diagnosis of thymic carcinoma that cannot be cured.
  • Have received previous treatment for thymic carcinoma or are not eligible for or refuse other treatments.
  • Have measurable cancer according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
  • Men must agree to use barrier contraception if their partner is of childbearing potential and agree not to donate sperm during the study and for 120 days after the last dose.
  • Agree not to donate eggs or sperm during the study and for 120 days after the last dose.
  • Women must agree not to breastfeed during the study and for 120 days after the last dose.

Exclusion Criteria

  • Have previously been treated with certain immune therapies targeting PD-1 or PD-L1.
  • Are currently enrolled in another clinical study, unless it is only for follow-up or observation.
  • Have received cancer treatment within the last three weeks or within five half-lives of the medication.
  • Have had significant radiation therapy within the last three months, with some exceptions for specific types of radiation.
  • Have not recovered from side effects of previous treatments, except for certain conditions like hair loss or mild nerve damage.
  • Have a known allergy to any of the study drugs.
  • Have an active autoimmune condition requiring immune-suppressing treatment.
  • Have had major surgery or serious injury within the last four weeks or plan to have major surgery soon.
  • Have poorly controlled high blood pressure or certain heart conditions.
  • Have had a heart attack or blood clot within the last six months.
  • Have active infections requiring treatment or certain viral infections that are not well-controlled.
  • Are pregnant, breastfeeding, or planning to conceive during the study and for 210 days after the last dose.
  • Have brain metastases that are not stable or have leptomeningeal disease.
  • Have had another cancer within the last two years, with some exceptions for certain early-stage cancers.
  • Have a history of bleeding disorders or are currently using certain blood thinners that are not stable.
  • Have certain gastrointestinal conditions or have had recent gastrointestinal surgery.
  • Have active lung disease or a history of non-infectious pneumonia.
  • Have a history of inflammatory bowel disease or chronic diarrhea.
  • Have a known history of HIV that is not well-controlled.
  • Are using systemic corticosteroids above a certain dose.
  • Have had an organ transplant or stem cell transplant.
  • Have received a live vaccine recently or plan to receive one during the study.
  • Have any serious medical conditions that could interfere with the study.
  • Are unable or unwilling to comply with the study requirements.

Locations

FACILITYZIPCITYSTATE
UCLA / Jonsson Comprehensive Cancer Center90095Los AngelesCalifornia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.