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PD-L1 Inhibitor

RAI + Immunotherapy for Thyroid Cancer

Phase < 1

Waitlist Available

Led By Alan Ho, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, hurthle cell or poorly differentiated subtypes and their respective variants)

At least one RAI-avid lesion identified on the most recent radioiodine scan OR at least one lesion on the most recent FDG PET scan with an SUV max of 10 or less

Must not have

Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1

Active or prior documented autoimmune disease within the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, durvalumab, to see if it can help treat thyroid cancer. Durvalumab blocks a protein that can be present on tumor and normal cells, which may help the immune system fight the cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Durvalumab may cause side effects such as immune-related reactions affecting different organs (like lungs causing pneumonitis), fatigue, skin rash and potential worsening of pre-existing autoimmune diseases. Radioiodine therapy can lead to dry mouth/throat issues due to salivary gland exposure and stomach discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My scans show at least one active cancer spot.

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My thyroid cancer has come back or spread.

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I am fully active or able to carry out light work.

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I can provide samples from my thyroid cancer for testing.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe side effects from previous immunotherapy.

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

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

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I have had pneumonitis before.

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I have an active case of tuberculosis.

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I have symptoms from cancer spread to my brain, spinal cord, or leptomeninges.

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I have no lasting side effects from cancer treatment worse than mild.

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I have or had inflammatory bowel disease.

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I cannot follow a low iodine diet or need medication high in iodide.

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I haven't had 131I therapy in the last 6 months.

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I have seizures that are not controlled by medication.

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I do not have any unmanaged ongoing illnesses.

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I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients With Dose-Limiting Toxicity (DLTs)

Secondary study objectives

Best Overall Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radioiodine (RAI) in Combination with Durvalumab (Medi4736)Experimental Treatment2 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.

0 / 19Eligibility criteria met