Cosmos311
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory
Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy
Logo:
Acronym:
Cosmic311
Summary & Eligibility:
Based on the patients history of treatment with an anti PD-L1 antibody, the patient will be randomly assigned of one of 6 arms (whether prior exposure or no exposure to anti PD-L1)
Inclusion Criteria
To be eligible, all of the following inclusion criteria must be met:
- Histologically or cytologically confirmed diagnosis of DTC
- Must have been previously treated with or deemed ineligible for treatment with Iodine-131 for DTC
- Must have been previously treated with at least one of the following VEGFR-targeting TKI agents for DTC: lenvatinib or sorafenib.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Exclusion Criteria
The patient is ineligible if any one of the following exclusion criteria are met:
- Prior treatment with any of the following:
a. Cabozantinib
b. Selective small-molecule BRAF kinase inhibitor (eg, vemurafenib, dabrafenib)
c. More than 2 VEGFR-targeting TKI agents (eg, lenvatinib, sorafenib, sunitinib,
pazopanib, axitinib, vandetanib)
d. More than 1 immune checkpoint inhibitor therapy (eg, PD-1 or PD-L1 targeting agent)
e. More than 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent)
- Known brain metastases
Status:
Open
Sponsor:
Exelixis, Inc
Study Schema:
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of cabozantinib.
Approximately 300 eligible subjects will be randomized in a 2:1 ratio to receive either cabozantinib or placebo.
Subjects’ trial participation will consist of the following periods:
Pretreatment Period: Potential subjects will be screened to determine if they meet the required eligibility criteria. Qualifying screening assessments must be performed within 28 days before randomization unless otherwise specified.
Treatment Period: Subjects who meet all study eligibility criteria will be randomly assigned in a 2:1 ratio to the following treatment arms:
• Cabozantinib arm: Oral cabozantinib (60 mg) daily (qd)
• Placebo arm: Oral cabozantinib-matched placebo qd
Study Coordinated by PRAHealth SciencesCos
