Tislelizumab in People With Colorectal Cancer

NCT06529523 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 24-063
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief 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. 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

Keywords

Tislelizumab; PD-1 blockade; 24-063

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Study Arms (2)

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.

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.

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

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).

Cohort 1: Stage 4 Colorectal cancer; Cohort 2: Stage 2/3 Rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• BeiGene USA, Inc.: collaborator

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Lagos University Teaching Hospital

Idi Araba, Lagos, Nigeria

NOT YET RECRUITING

Obafemi Awolowo University Teaching Hospital

Ile-Ife, Nigeria

NOT YET RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Fiyinfolu O Balogun, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiyinfolu O Balogun, MD, PhD

CONTACT

646-888-6964; balogunf@mskcc.org

Peter Kingham, MD

CONTACT

212-639-5260

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1); NG (2)