PDR001 + Trametinib/Dabrafenib for Thyroid Cancer

Recruiting at9 trial locations

Overseen by Alan L Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether a drug called PDR001, combined with either trametinib or dabrafenib, is a safe and effective treatment for thyroid cancer.

Research Team

Alan L Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with certain types of thyroid cancer that have progressed despite previous treatments and can't be cured with surgery or radiation. They must not have a specific mutation (BRAFV600-), should be in good physical condition, able to swallow pills, and not on immunosuppressive drugs. Pregnant women or those who might become pregnant without contraception are excluded.

Inclusion Criteria

Patients must have a measurable disease according to RECIST v1.1 guidelines.

I can swallow pills without any major stomach or intestine problems.

I have tissue samples from my cancer available for study.

Exclusion Criteria

I have an autoimmune disease, but it might be an exception.

I have a history of lung disease not caused by infections.

I have symptoms from cancer spread to my brain or its coverings.

Treatment Details

Interventions

• Dabrafenib (Kinase Inhibitor)
• PDR001 (Monoclonal Antibodies)
• Trametinib (Kinase Inhibitor)

Trial Overview The trial is testing the effectiveness of PDR001 combined with trametinib or dabrafenib for treating advanced thyroid cancer. It aims to determine if this combination therapy is safe and beneficial for patients whose cancer has continued to progress after other treatments.

Participant Groups

Group I: Cohort B-BRAF Mutant Experimental Treatment 2 Interventions

Cohort B (BRAF Mutant, resistant to previous BRAF inhibitors): dabrafenib (D) 150 mg twice daily (OR at dose the patient previously tolerated) plus PDR001 400mg IV every 4 weeks.

Group II: Cohort A-BRAF WT tumors Experimental Treatment 2 Interventions

Cohort A (BRAF WT tumors): trametinib (T) 2mg by mouth daily plus PDR001 400mg IV every 4 weeks

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University