BridgeMD
New treatment option for Colorectal Cancer
Official title Tislelizumab in People With Colorectal Cancer
ClinicalTrials.gov ID: NCT06529523
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All people
- 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...
You likely can't join 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...
- 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...
See the full eligibility criteria
Who can join
- All people
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
- \ 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)...
- 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...
- 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 people
- 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 people
- 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 ×...
- Hepatic
- Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for people 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...
What rules you out
- 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...
- 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...
- 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...
- 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: a. 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...
- Cohort 1 people
- 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...
- 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 ≥...
- Cohort 2 people
- Prior immunotherapy, chemotherapy, radiation therapy, or surgery for localized rectal cancer
- Presence of metastatic or recurrent disease
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Idi-Araba, Lagos, Nigeria
- Ile-Ife, Nigeria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Idi-Araba, Lagos, Nigeria; Ile-Ife, Nigeria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.