Phase II Study of Cabozantinib and Pembrolizumab for Advanced Stomach and Gastroesophageal Cancer

Sponsor: University of California, Irvine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04164979

Provider View

This clinical trial is testing a combination of two drugs, cabozantinib and pembrolizumab, to see if they are effective in treating advanced stomach and gastroesophageal cancer in patients who have not responded well to previous treatments.

Patient Parameters

Program Overview

This study is exploring the effectiveness of combining two drugs, cabozantinib and pembrolizumab, for treating advanced stomach and gastroesophageal cancer. It is designed for patients whose cancer has progressed or who could not tolerate at least one prior chemotherapy treatment that included specific drugs. The treatment will be given in cycles lasting 21 days each.

Description

The trial involves administering the treatment in 21-day cycles. Participants must have advanced stomach or gastroesophageal cancer that cannot be removed by surgery. They should have tried at least one previous treatment with specific chemotherapy drugs but did not respond well or could not tolerate it. The study will assess how well the combination of cabozantinib and pembrolizumab works in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced stomach or gastroesophageal cancer that cannot be surgically removed.
  • Cancer has progressed after at least one treatment with specific chemotherapy drugs.
  • Must have tried a treatment that included a checkpoint inhibitor if certain test scores are known or high.
  • Aged 18 years or older.
  • In good general health with a performance status score of 2 or less.
  • Life expectancy of more than 3 months.
  • Adequate blood and organ function based on specific medical tests.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for 4 months after.
  • Able to swallow tablets and willing to sign informed consent.
  • Patients with certain genetic tumor markers must have tried immunotherapy before.

Exclusion Criteria

  • Recent chemotherapy within 2 weeks before starting the study.
  • Unresolved side effects from previous cancer treatments.
  • Currently taking other investigational drugs.
  • Known brain metastases unless treated and stable for at least 4 weeks.
  • Allergic reactions to similar drugs used in the study.
  • Taking certain blood thinners or anticoagulants.
  • Uncontrolled health conditions like infections, heart failure, or high blood pressure.
  • Recent major surgery or not fully recovered from surgery.
  • Previous treatment with cabozantinib.
  • Certain heart conditions based on ECG results.
  • Recent use of other cancer treatments or live vaccines.
  • Pregnant or nursing women.
  • History of other cancers within the last 3 years, except for specific types.
  • Unable to comply with study procedures.
  • Active autoimmune diseases requiring treatment in the past 2 years.
  • Active infections or history of certain infections like HIV or tuberculosis.

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