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 — 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).

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 cancer
    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.
  • Experimental: Cohort 2: Stage 2/3 Rectal cancer
    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.

Primary Outcome Measure

objective response rate of PD-1 blockade with tislelizumab [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Fiyinfoliu Balogun, MD, PhD
646-888-6964

Find similar trials in New York, NY

By condition

Related Studies