Tislelizumab for Colorectal Cancer in Nigeria
This study is testing a drug called tislelizumab to see how well it works and if it's safe for people in Nigeria with colorectal cancer. You might be able to join if you are 18 or older, have not yet received treatment for your cancer, and your cancer has a specific feature called mismatch repair deficiency (dMMR). dMMR means your body's cells have trouble fixing mistakes when they divide. The study aims to find out how many people respond to tislelizumab, with results measured over two years. The study plans to enroll 40 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 40 participants.
- What's involved
- You would receive tislelizumab 200mg intravenously (into a vein) every three weeks until your cancer gets worse, you experience severe side effects, you or your doctor decide to stop, or for up to 104 weeks (35 doses).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, objective response rate, will be measured at 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06529523
Tislelizumab in People With Colorectal Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~40 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Tislelizumab
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
objective response rate of PD-1 blockade with tislelizumab
Measured over 2 years
Conditions
Where it's being run
3 sites across 3 statesNew York1
Lagos1
Nigeria1
Study leadership
- Fiyinfolu O Balogun, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age 18 years or older on date of signing informed consent
ECOG performance status of 0 or 1
Negative pregnancy test done within 72 hours prior to start of treatment for women of childbearing potential.
Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab They must also have a negative urine or serum pregnancy test result ≤ 7 days before first dose of study drug.
The Clinical Trials Facilitation Group recommendations related to contraception and pregnancy testing in clinical studies include the use of highly effective forms of birth control (Clinical Trials Facilitation Group 2014). These methods include the following:
Oral, intravaginal, or transdermal combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation
Oral, injectable, implantable progestogen-only hormonal contraception associated with the inhibition of ovulation Note: Oral birth control pills are not considered a highly effective form of birth control, and if they are selected, they must be used with a second, barrier method of contraception such as condoms with or without spermicide.
An intrauterine device
Intrauterine hormone-releasing system
Bilateral tubal occlusion
Vasectomized partner Note: This is only considered a highly effective form of birth control when the vasectomized partner is the sole partner of the study participant and there has been a medical assessment confirming surgical success.
A sterile male is one for whom azoospermia, in a semen sample, has been demonstrated as definitive evidence of infertility.
Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) Note: Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle.
Surgically sterile (ie, through bilateral salpingectomy, bilateral oophorectomy, or hysterectomy)
Postmenopausal, defined as:
≥ 55 years of age with no spontaneous menses for ≥ 12 months OR
\< 55 years of age with no spontaneous menses for ≥ 12 months AND with postmenopausal follicle-stimulating hormone (FSH) concentration \> 30 IU/mL and all alternative medical causes for the lack of spontaneous menses for ≥ 12 months have been ruled out, such as polycystic ovarian syndrome, hyperprolactinemia, etc.
If an FSH measurement is required to confirm postmenopausal state, concomitant use of hormonal contraception or hormonal replacement therapy should be excluded.
Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab
Males with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile.
The ability to adhere to the study protocol and willingness to provide informed consent
Cohort 1 subjects
Histological confirmation of colorectal adenocarcinoma
Confirmation of dMMR by immunohistochemistry
Radiologically measurable metastatic disease as per RECIST 1.1, not eligible for potentially curative surgery -Cohort 2 subjects
Histological confirmation of rectal adenocarcinoma
Confirmation of dMMR by immunohistochemistry
Rectal cancer stage II or III per AJCC 8 th edition criteria
No evidence of distant metastases
Hematological
Absolute neutrophil count (ANC) ≥1,500 /mm\^3
Platelets ≥100,000 / mcL
Hemoglobin \>9 g/dL or ≥5.6 mmol/L
Renal
Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥30 mL/min for subject with creatinine levels \> 1.5 × institutional ULN
Hepatic
Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (\< 5 x ULN if hepatic metastases are present in cohort 1
Coagulation
International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) INR \<1.5 or PT \<1.5 x ULN; and either PTT or aPTT \<1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \<3.5
Exclusion
Presence of other active malignancy
Diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days prior to first dose of treatment
Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of an active autoimmune disease. Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
Active autoimmune disease requiring systemic therapy within the 2 years prior to treatment initiation
Untreated active Hepatitis B or Hepatitis C
Untreated Acquired Immunodeficiency Syndrome (AIDS)
Infection (including tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before first dose of study drug
History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis.
Currently receiving other anticancer or experimental therapy
Has received prior therapy with an immune checkpoint inhibitor
Prior ≥ Grade 3 immune-related AE from previous immunotherapy
Pregnant women, women who are breast-feeding, or men expecting to conceive or father children during the trial period, through 120 days after last dose of medication
Receipt of live vaccine within 30 days of planned treatment start
Major surgical procedure or significant traumatic injury within 28 days prior to enrollment
Known hypersensitivity to Tislelizumab
Prior allogeneic stem cell or organ transplantation
Any of the following cardiovascular risk factors:
Cohort 1 subjects
Prior immunotherapy, chemotherapy, radiation therapy, or surgery for metastatic colorectal cancer
Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis
Cohort 2 subjects
Prior immunotherapy, chemotherapy, radiation therapy, or surgery for localized rectal cancer
Presence of metastatic or recurrent disease
What this trial measures
- objective response rate of PD-1 blockade with tislelizumab2 years
(ORR, defined as CR or PR) as measured by RECIST 1.1 in patients with mismatch repair deficient metastatic colorectal adenocarcinoma (cohort 1) and in patients with mismatch repair deficient localized (stage II/III) rectal adenocarcinoma (cohort 2).