Actively Recruiting
Tislelizumab in People With Colorectal Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-10-07
40
Participants Needed
3
Research Sites
205 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
B
BeiGene USA, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug. All participants in this study will be treatment naïve (they have not yet received treatment for their cancer), and their cancer will be mismatch repair deficient (dMMR). dMMR cancer can happen when your cells are unable to repair mistakes made during the cell division process.
CONDITIONS
Official Title
Tislelizumab in People With Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- ECOG performance status of 0 or 1
- Negative pregnancy test within 72 hours before treatment start for women who can become pregnant
- Women of childbearing potential must agree to use a highly effective birth control method during the study and for at least 120 days after the last dose
- Men who are not sterile must agree to use a highly effective birth control method during the study and for at least 120 days after the last dose
- Histological confirmation of colorectal or rectal adenocarcinoma
- Confirmation of mismatch repair deficiency (dMMR) by immunohistochemistry
- Measurable metastatic disease by imaging for cohort 1, not eligible for curative surgery
- Stage II or III rectal cancer without distant metastases for cohort 2
- Adequate organ function within 14 days before treatment start
- Ability to follow study protocol and provide informed consent
You will not qualify if you...
- Presence of other active cancers
- Diagnosis of immunodeficiency or use of systemic steroids or immunosuppressive therapy within 7 days before starting treatment
- Systemic corticosteroids over 10 mg prednisone equivalent within 14 days before treatment, except certain allowed forms
- Active autoimmune disease requiring systemic treatment within 2 years prior to treatment
- Untreated active Hepatitis B or C infection
- Untreated AIDS, though controlled HIV on therapy is allowed
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before treatment
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases
- Receiving other anticancer or experimental therapy
- Previous treatment with immune checkpoint inhibitors
- Prior severe immune-related adverse events from immunotherapy
- Pregnant or breastfeeding women, or men planning to conceive during and 120 days after treatment
- Receipt of live vaccine within 30 days before treatment
- Major surgery or significant injury within 28 days before enrollment
- Known allergy to tislelizumab
- Prior allogeneic stem cell or organ transplant
- Recent serious cardiovascular conditions or uncontrolled hypertension
- For cohort 1: prior treatment for metastatic colorectal cancer except adjuvant therapy completed at least 6 months before
- Known active brain metastases or carcinomatous meningitis unless stable
- For cohort 2: prior treatment for localized rectal cancer or metastatic/recurrent disease
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
Lagos University Teaching Hospital
Idi Araba, Lagos, Nigeria
Not Yet Recruiting
3
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Nigeria
Not Yet Recruiting
Research Team
F
Fiyinfolu O Balogun, MD, PhD
CONTACT
P
Peter Kingham, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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