RAI + Immunotherapy for Thyroid Cancer

Recruiting at8 trial locations

Overseen by Alan L Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out what effects, good and/or bad, a drug called durvalumab combined with Thyrogen-stimulated RAI, has on the patient and thyroid cancer. Durvalumab is a drug that has been developed to activate the immune system by blocking a protein called programmed death ligand-1 (PD-L1) that can be present on tumor and normal cells, including immune cells.

Research Team

Alan L Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with certain types of thyroid cancer that has returned or spread, and who have at least one tumor visible on specific scans. They should be in good physical condition, able to follow the study's procedures including biopsies, and not have had certain recent treatments or conditions like severe allergies to durvalumab or Thyrogen, autoimmune diseases, lung inflammation history, organ transplants, uncontrolled illnesses or brain metastases.

Inclusion Criteria

Patients must agree to undergo two research biopsies of malignant lesions

My thyroid cancer is confirmed and is of a type that started in the follicular cells.

My scans show at least one active cancer spot.

Exclusion Criteria

I have had severe side effects from previous immunotherapy.

I have had an autoimmune disease in the last 2 years.

I have previously been treated with a PD1 or PD-L1 inhibitor.

Treatment Details

Interventions

• Durvalumab (PD-L1 Inhibitor)
• Radioiodine (RAI) (Radioactive Iodine)

Trial Overview The trial tests the combination of a drug called durvalumab (which boosts the immune system by blocking PD-L1 protein) with radioiodine therapy stimulated by Thyrogen in patients with recurrent/metastatic thyroid cancers. The goal is to assess the effectiveness and safety of this combination treatment.

Participant Groups

Group I: Radioiodine (RAI) in Combination with Durvalumab (Medi4736) Experimental Treatment 2 Interventions

Enrolled patients will be treated with durvalumab 1500 mg IV every 4 weeks. In Cycle 1/Week 3, Thyrogen 0.9 mg IM will be administered on two consecutive calendar days followed by 100 mCi (+/- 10 mCi) of RAI the next calendar day. Durvalumab will be continued every 4 weeks.

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

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

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

MedImmune LLC

Industry Sponsor

Trials

348

Recruited

788,000+

Founded

1988

Headquarters

Gaithersburg, USA

Known For

Biologics research

Top Products

Synagis, FluMist

Dr. Reginald Seeto

MedImmune LLC

Chief Medical Officer since 2008

MD from University of Sydney, B.Sc. from University of Sydney

Peter Greenleaf

MedImmune LLC

Chief Executive Officer since 2006

MBA from St. Joseph’s University, B.S. from Western Connecticut State University