XL092 and Cemiplimab in BRAF WT Thyroid Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06902376
Phase
PHASE1
Status
Recruiting
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Conditions

  • Anaplastic Thyroid Cancer
  • BRAF Mutation-Related Tumors
  • Thyroid Cancer

Eligibility Criteria

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

Interventions

  • Cemiplimab — BIOLOGICAL
    Cemiplimab will be administered at a dose of 350mg intravenous over 30 minutes every 3 weeks for 3 cycles (cycle length is 21 days) at weeks 1, 4, and 7.
  • XL092 — DRUG
    XL092 will be administered at a dose of 60mg PO daily for 8 weeks (weeks 1-8)

Study Details

This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical resection in participants with wild-type (WT) anaplastic thyroid cancer (ATC) that has a BRAF mutation (BRAF V600E).

Key Dates

Start date
Jun 3, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2028
Completion
Aug 31, 2028

Study Design

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

Arms

  • Experimental: neoadjuvant XL092 and cemiplimab
    Subjects with BRAFV600E wild type (WT) anaplastic thyroid cancer (ATC) who are scheduled to undergo surgical resection as part of their standard of care will receive neoadjuvant XL092 and cemiplimab. Adjuvant therapy may be indicated based on surgical pathology.

Primary Outcome Measure

Complete gross resection [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber/Harvard Cancer CenterBostonMassachusetts02215
Veronica Bedard
617-582-7323
Theodora Pappa, MD, PhD
[email protected]
617-732-5666
Theodora Pappa, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Siddharth Sheth, MD
[email protected]
Melissa B Flores
[email protected]
(919)-966-4432

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By research site
Dana Farber/Harvard Cancer Center· Boston, MAUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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