Study on Combination Therapies for Second Line Treatment in Advanced Gastroesophageal Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06445972

This clinical trial is testing new combination therapies for patients with advanced gastroesophageal cancer who have not responded to their first treatment. The study compares two different drug combinations to see which is more effective and safe.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of two different drug combinations for treating advanced gastroesophageal cancer. Patients who have already tried one line of treatment without success will receive either MK-2870 with paclitaxel or Ramucirumab with paclitaxel. The study aims to find out which combination works better in controlling the cancer.

Description

The main protocol for this study is MK-3475-U06. It is a phase 1/2 study conducted across multiple centers, where participants will receive one of two drug combinations to treat their advanced gastroesophageal cancer. The study will not perform formal hypothesis testing but will estimate the safety and effectiveness of the treatments.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced gastroesophageal cancer that has been treated before.
  • The cancer must have spread or be too advanced to be removed by surgery.
  • The cancer must have worsened during or after the first treatment, which included specific chemotherapy drugs.
  • The cancer must not be HER2 positive.
  • Must be able to provide a sample of the tumor tissue.
  • Side effects from previous treatments must be mild or back to baseline, except for hair loss and skin changes.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have a life expectancy of at least 3 months.

Exclusion Criteria

  • Have a different type of esophageal cancer, such as squamous cell cancer.
  • Have lost more than 20% of body weight in the last 3 months.
  • Have severe eye conditions that affect healing.
  • Have significant nerve damage.
  • Have active inflammatory bowel disease or a history of it.
  • Have serious wounds or ulcers that are not healing.
  • Have bowel obstruction or severe digestive issues.
  • Have uncontrolled heart or blood vessel disease.
  • Have had a heart attack or stroke in the last 6 months.
  • Have uncontrolled high blood pressure.
  • Have fluid buildup that needs frequent drainage.
  • Have had major surgery recently or plan to have it soon.
  • Are taking blood thinners or certain anti-inflammatory drugs.
  • Have a history of significant blood clots.
  • Have bleeding disorders or recent significant bleeding.
  • Have a history of gastrointestinal perforation.
  • Have HIV infection.
  • Have had cancer treatment or investigational drugs recently.
  • Have had recent radiation therapy with ongoing side effects.
  • Have had a live vaccine recently.
  • Have another active cancer.
  • Have active brain metastases or meningitis.
  • Have an active infection needing treatment.
  • Have active hepatitis B or C infection.
  • Have severe allergies to study drugs.
  • Have not recovered from major surgery.

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