Study on Tislelizumab for People with Colorectal Cancer in Nigeria

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06529523

Provider View

This clinical trial is exploring whether the drug tislelizumab is a safe and effective treatment for people in Nigeria with colorectal cancer that has not been treated before and has a specific genetic feature called mismatch repair deficiency (dMMR).

Patient Parameters

Program Overview

The purpose of this study is to determine if the drug tislelizumab can effectively treat colorectal cancer in people living in Nigeria. The study will focus on patients who have not received any prior treatment for their cancer and whose cancer cells have a specific characteristic known as mismatch repair deficiency (dMMR). This condition occurs when cells cannot fix errors that happen during cell division. Researchers will also assess the safety of tislelizumab in these patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment and agree to use effective birth control during the study and for at least 120 days after the last dose.
  • Men must agree to use effective birth control during the study and for at least 120 days after the last dose.
  • Must have adequate organ function as shown by specific blood tests.
  • For Cohort 1: Must have colorectal cancer confirmed by lab tests, with dMMR, and measurable metastatic disease not eligible for surgery.
  • For Cohort 2: Must have rectal cancer confirmed by lab tests, with dMMR, and stage II or III cancer without distant spread.
  • Must meet specific blood count and organ function criteria.

Exclusion Criteria

  • Have another active cancer.
  • Have an immune system deficiency or are taking immune-suppressing medications.
  • Have an active autoimmune disease needing treatment in the past two years.
  • Have untreated Hepatitis B or C, or untreated HIV/AIDS.
  • Have an infection needing treatment within 14 days before starting the study.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Are currently receiving other cancer treatments.
  • Have had a severe reaction to previous immunotherapy.
  • Are pregnant, breastfeeding, or planning to have children during the study and for 120 days after.
  • Have had a live vaccine within 30 days before starting the study.
  • Have had major surgery or a significant injury within 28 days before starting the study.
  • Have a known allergy to tislelizumab.
  • Have had a stem cell or organ transplant.
  • Have certain heart conditions or risk factors.
  • For Cohort 1: Have had previous treatments for metastatic colorectal cancer.
  • For Cohort 2: Have had previous treatments for localized rectal cancer.
  • Have active brain metastases or cancer in the brain lining.

Get This Program In Your Inbox

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