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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients With Dose-Limiting Toxicity (DLTs)
Secondary outcome measures
Best Overall Response
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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,881 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,289 Previous Clinical Trials
288,620,187 Total Patients Enrolled
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,898 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have had pneumonitis before.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.I have an active case of tuberculosis.I have symptoms from cancer spread to my brain, spinal cord, or leptomeninges.I have not received a live vaccine within 30 days before joining the study or before getting durvalumab.I have no lasting side effects from cancer treatment worse than mild.I have or had inflammatory bowel disease.I cannot follow a low iodine diet or need medication high in iodide.Patients must have a condition that can be measured.My thyroid cancer has come back or spread.I am fully active or able to carry out light work.My organs and bone marrow are functioning well.I can provide samples from my thyroid cancer for testing.I haven't had 131I therapy in the last 6 months.I haven't had cancer treatments like chemotherapy or immunotherapy in the last 28 days.I am 18 years old or older.I have not had external beam radiation therapy in the last 4 weeks.I am willing and able to follow the study's treatment plan and attend all visits.You have had a severe allergic reaction to Thyrogen.I have seizures that are not controlled by medication.You have a history of a weak immune system from birth.You have received an organ from someone else in the past.I haven't taken immunosuppressive drugs in the last 28 days.You have had a bad reaction to durvalumab or any of its ingredients in the past.I do not have any unmanaged ongoing illnesses.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Radioiodine (RAI) in Combination with Durvalumab (Medi4736)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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