Zanzalintinib Plus Cemiplimab for the Treatment of BRAF Wild-Type Anaplastic Thyroid Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07470489
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anaplastic Thyroid Cancer

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Given by IV
  • Zanzalintinib — DRUG
    Given by IV

Study Details

The goal of the trial is to improve this OS by 4 months (to 9.9 months) using the zanzalintinib + cemiplimab treatment combination. Given an accrual period of 24 months and a maximum follow-up time of 36 months, at the significance level of 0.1, to achieve the power of 0.8, the sample size needed is 24 patients and the number of events required is 17. These results are based on a one-sided test with exponential assumption for survival time.

Key Dates

Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2032

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Zanzalintinib + Cemiplimab
    Participants will be treated in 21-day cycles with zanzalintinib 60 mg po daily from days 1-21 and cemiplimab 350 mg IV on day 1 of each cycle. Patients will be treated for a maximum of 24 cycles.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Sarah Hamidi, MD
[email protected]
713-794-1472
Sarah Hamidi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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