Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03879811
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TMZ — DRUG
    Oral TMZ at 150mg/m2
  • Nivolumab — DRUG
    Nivolumab via IV infusion at 480 mg every four weeks (Q4W) starting 4 weeks after TMZ day 1

Study Details

The purpose of this study is to find out whether temozolomide followed by nivolumab is an effective treatment for MMR-proficient colorectal cancer, while causing few or mild side effects.

Key Dates

Start date
Mar 13, 2019
Status verified
Dec 2019
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MMR-Proficient Colorectal Cancer
    The first 3 subjects will receive oral TMZ at 150mg/m2 day 1 to 5 during cycle 1, followed by nivolumab via IV infusion at 480 mg every four weeks (Q4W) starting 4 weeks after TMZ day 1 (i.e. Cycle 2 day 1). Nivolumab will continue for up for 2 years maximum. If confirmed that TMB increased in at least 2 of 3 subjects following 1 cycle of TMZ, then subsequent patients will continue to receive TMZ during cycle 1 only, and the original three participants will not be replaced. If it is determined that TMB did not increase following 1 cycle of TMZ, then subsequent patients will receive TMZ up to cycle 3, those first 3 patients will discontinue further Nivolumab and be replaced and an additional 6 patients will initially be enrolled. If confirmed that TMB increased in at least 1 of 6 subjects following 3 cycles of TMZ, then 12 more patients will be allowed to enroll for a total of 18 in stage I.

Primary Outcome Measure

response rate of TMZ followed by nivolumab in participants with MMR-proficient Colorectal Cancer [ Time Frame: up to 2 years ]

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