Colorectal CancerPhase 2NCT06529523
Tislelizumab in People With Colorectal Cancer
A Phase 2 study testing Tislelizumab in people with Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 Jul 2024to Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Periodic abstinence (eg, calendar, ovulation, sympto-thermal, postovulation methods), declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable methods of contraception.
- Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception; if used, this method must be used in combination with one of the highly effective forms of birth control listed above.
- °"Women of non-childbearing potential" are defined as female patients meeting any of the following criteria:
- 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.
- [Adapted from Clinical Trials Facilitation Group (CTFG) 2014.]
- 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
- •A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility.
- Males with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile.
- Demonstration of adequate organ function below within 14 days of cycle 1 day 1
- 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
Who cannot join
- 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:
- Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
- Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
- Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen
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- Active autoimmune disease requiring systemic therapy within the 2 years prior to treatment initiation
- o Well controlled hypothyroidism, diabetes, and skin conditions allowed
- Untreated active Hepatitis B or Hepatitis C
- o Patients actively on therapy with disease under control are allowed
- Untreated Acquired Immunodeficiency Syndrome (AIDS)
- o Patients with Human Immunodeficiency Virus (HIV) well controlled on anti-retroviral therapy are allowed
- 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.
- o Patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening
- 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:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drug e. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug g. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before first dose of study drug h. Any episode of syncope or seizure ≤ 28 days before first dose of study drug
- Cohort 1 subjects
- Prior immunotherapy, chemotherapy, radiation therapy, or surgery for metastatic colorectal cancer
- o Treatment with adjuvant therapy of prior localized tumor is allowable as long as it was completed at least 6 months prior to cycle 1 day 1
- Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis
- o Patients with previously treated brain metastases may participate if the brain metastases are stable via MRI assessment, performed ≥ 4 weeks after treatment
- Cohort 2 subjects
- Prior immunotherapy, chemotherapy, radiation therapy, or surgery for localized rectal cancer
- Presence of metastatic or recurrent disease
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Peter Kingham, MD contact
3 sites in 2 countries
Nigeria2 sites, 2 recruiting
- Not yet recruiting
Lagos University Teaching Hospital
Idi-Araba, Lagos
Fatimah Abdulkareem, MD, 08122167403
- Not yet recruiting
Obafemi Awolowo University Teaching Hospital
Ile-Ife
Isaac Alatise, MD, segunalatishe@oau.edu.ng
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fiyinfoliu Balogun, MD, PhD, 646-888-6964
About this study
Official title: PD-1 (Programmed Cell Death Protein 1) Blockade in Mismatch-repair Deficient Colorectal Cancer in Nigeria
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
- Colorectal Cancer
- Being tested
- Tislelizumab
- Keywords
- Tislelizumab, PD-1 blockade, 24-063
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Patients will receive standard dose of tislelizumab 200mg IV flat dose q3weeks until disease progression, unacceptable toxicity, patient/physician decides to withdraw patient, death, or completion of 104 weeks treatment (35 administrations).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Stage 4 Colorectal cancer | Experimental | All patients in the trial will be given Tislelizumab at a dose of 200mg IV over 30 minutes (60 minutes at the initial infusion), every 3 weeks. Receives: Drug: Tislelizumab |
| Cohort 2: Stage 2/3 Rectal cancer | Experimental | All patients in the trial will be given Tislelizumab at a dose of 200mg IV over 30 minutes (60 minutes at the initial infusion), every 3 weeks. Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate of PD-1 blockade with tislelizumab
(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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start26 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot, open label to gather preliminary data on the use of PD-1 blockade therapy in patients with metastatic dMMR CRC (cohort 1) and patients with localized (stage II/III) dMMR rectal cancer (cohort 2).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines
- Responsible party
- Sponsor
- Investigators
- Fiyinfolu O Balogun, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529523
- Sponsor's protocol ID
- 24-063
- Status last verified
- Nov 2026
- First submitted
- 26 Jul 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 (Programmed Cell Death Protein 1) Blockade in Mismatch-repair Deficient Colorectal Cancer in Nigeria
- ClinicalTrials.gov ID
- NCT06529523
- Acronym / sponsor ID
- 24-063
- Conditions
- Colorectal Cancer
- Keywords
- Tislelizumab, PD-1 blockade, 24-063
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- BeOne Medicines
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot, open label to gather preliminary data on the use of PD-1 blockade therapy in patients with metastatic dMMR CRC (cohort 1) and patients with localized (stage II/III) dMMR rectal cancer (cohort 2).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Stage 4 Colorectal cancer | Experimental | Drug: TislelizumabAll patients in the trial will be given Tislelizumab at a dose of 200mg IV over 30 minutes (60 minutes at the initial infusion), every 3 weeks. |
| Cohort 2: Stage 2/3 Rectal cancer | Experimental | Drug: TislelizumabAll patients in the trial will be given Tislelizumab at a dose of 200mg IV over 30 minutes (60 minutes at the initial infusion), every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- 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.
- Periodic abstinence (eg, calendar, ovulation, sympto-thermal, postovulation methods), declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable methods of contraception.
- Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception; if used, this method must be used in combination with one of the highly effective forms of birth control listed above.
Key exclusion criteria (33 listed)
- 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
- o Well controlled hypothyroidism, diabetes, and skin conditions allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabPatients will receive standard dose of tislelizumab 200mg IV flat dose q3weeks until disease progression, unacceptable toxicity, patient/physician decides to withdraw patient, death, or completion of 104 weeks treatment (35 administrations). | Drug | Cohort 1: Stage 4 Colorectal cancer, Cohort 2: Stage 2/3 Rectal cancer |
Primary outcome
objective response rate of PD-1 blockade with tislelizumab
Time frame: 2 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Kingham, MD contact
Fiyinfolu O Balogun, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiyinfolu O Balogun, MD, PhD (646-888-6964, balogunf@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate of PD-1 blockade with tislelizumab (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.