RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03215095
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab (Medi4736) — DRUG
    durvalumab 1500 mg IV every 4 weeks
  • Radioiodine (RAI) — RADIATION
    100 mCi (+/- 10 mCi) of 131I will be administered a day after Thyrogen injections have been administered for two consecutive calendar days.

Study Details

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.

Key Dates

Start date
Jul 10, 2017
Status verified
Jul 2025
Primary completion
Feb 6, 2023
Completion
Jul 31, 2026

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radioiodine (RAI) in Combination with Durvalumab (Medi4736)
    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.

Primary Outcome Measure

Number of Patients With Dose-Limiting Toxicity (DLTs) [ Time Frame: 6 weeks beginning from the first durvalumab ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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