Tislelizumab in People With Colorectal Cancer
Part of paid clinical trials in New York, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT06529523
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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).
Study Details
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.
Key Dates
- Start date
- Jul 26, 2024
- Status verified
- Oct 2025
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: Stage 4 Colorectal cancerAll 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.
- Experimental: Cohort 2: Stage 2/3 Rectal cancerAll 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.
Primary Outcome Measure
objective response rate of PD-1 blockade with tislelizumab [ Time Frame: 2 years ]
Central Contacts
- Fiyinfolu O Balogun, MD, PhD646-888-6964
- Peter Kingham, MD212-639-5260
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Fiyinfoliu Balogun, MD, PhD 646-888-6964 |
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