Study on Ivonescimab with FOLFOX for Advanced HER2 Negative Gastroesophageal Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07070466

Provider View

This clinical trial is testing a new treatment combining ivonescimab with standard chemotherapy (FOLFOX) to see if it can improve outcomes for patients with advanced HER2 negative gastroesophageal cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with advanced gastroesophageal cancer that is HER2 negative. The treatment combines a new drug, ivonescimab, with standard chemotherapy drugs 5-fluorouracil (5FU) and oxaliplatin, known as FOLFOX. The goal is to see if this combination can help overcome resistance to immunotherapy and improve the response rate and progression-free survival in patients who have not received prior treatment for advanced cancer.

Description

This clinical trial is testing a new combination of treatments for patients with advanced gastroesophageal cancer that is HER2 negative. The study involves using ivonescimab, a new type of drug that targets specific proteins involved in cancer growth, along with standard chemotherapy drugs 5-fluorouracil (5FU) and oxaliplatin (FOLFOX). The aim is to see if this combination can improve how well the cancer responds to treatment and how long patients can live without the cancer getting worse. The study will also assess the safety and tolerability of this treatment combination. Participants will receive the treatment and undergo regular health checks to monitor their response and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma of the esophagus, gastroesophageal junction, or stomach. Squamous cell tumors are not eligible.
  • Cancer must be HER2 negative and able to be evaluated by scans.
  • No prior treatment for Stage IV disease, except for adjuvant therapy completed more than 6 months ago.
  • Age 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Meet specific blood and organ function criteria, including:
    • Neutrophil count of at least 1,500/mcL
    • Hemoglobin level above 9.0 g/dL
    • Platelet count of at least 100,000/mcL
    • Normal liver and kidney function tests
    • Controlled blood clotting times
  • For those with hepatitis B or C, the infection must be controlled or cured.
  • No active brain metastases, unless treated and stable.
  • Willing to use effective contraception during and after the study.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Previous treatment with PD-1 or PD-L1 inhibitors unless completed over 6 months ago.
  • Recent major surgery or plans for major surgery soon after starting the study.
  • Not fully recovered from previous cancer treatment side effects, except for mild hair loss or nerve damage.
  • Currently receiving other investigational treatments for this condition.
  • Allergic reactions to similar drugs, unless previously desensitized.
  • Pregnant or breastfeeding women.
  • History of significant gastrointestinal issues or surgeries.
  • Uncontrolled high blood pressure.
  • Recent serious blood clots or strokes.
  • History of poor wound healing.
  • Previous organ or stem cell transplants.
  • Uncontrolled illnesses or psychiatric conditions affecting study participation.
  • Recent heart problems or unstable heart conditions.
  • Use of certain medications affecting the immune system.
  • Active infections requiring recent intravenous treatment.
  • HIV infection unless well-controlled with stable treatment.
  • History of significant bleeding issues or current use of unstable blood thinners.
  • History of lung inflammation requiring treatment.

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