Tislelizumab in People With Colorectal Cancer
ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
Trial design
Design model
Parallel
Treatments tested in this trial
Tislelizumab
DrugPatients 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).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: Stage 4 Colorectal cancerExperimental treatment 1 intervention
Group B: Cohort 2: Stage 2/3 Rectal cancerExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov