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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

 

Charity appeal

Find out more about our £1m Charity appeal for the AcceleraTED cancer Treatment programme.