RECRUITING

Tislelizumab in People With Colorectal Cancer

Conditions

Colorectal Cancer Tislelizumab PD-1 blockade 24-063

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PD-1 Blockade in Mismatch-repair Deficient Colorectal Cancer in Nigeria

Quick Facts

Study Start:2024-07-26

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06529523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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. * 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	* 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: 1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) 2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption 3. 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 * 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: 1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug 2. Pulmonary embolism ≤ 28 days before first dose of study drug 3. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug 4. Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drug 5. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug 6. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug 7. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before first dose of study drug 8. 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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
* 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.
* 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

* 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:
1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
3. 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
* 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:
1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug
2. Pulmonary embolism ≤ 28 days before first dose of study drug
3. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug
4. Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drug
5. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug
6. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug
7. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before first dose of study drug
8. 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
* 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

Contacts and Locations

Study Contact

Fiyinfolu O Balogun, MD, PhD

CONTACT

646-888-6964

balogunf@mskcc.org

Peter Kingham, MD

CONTACT

212-639-5260

Principal Investigator

Fiyinfolu O Balogun, MD, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Fiyinfolu O Balogun, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26

Study Completion Date2028-07

Study Record Updates

Study Start Date2024-07-26

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

Tislelizumab
PD-1 blockade
24-063

Additional Relevant MeSH Terms

Colorectal Cancer