RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers (NCT03215095) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers
United States11 participantsStarted 2017-07-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
* Diagnosis of recurrent and/or metastatic thyroid cancer
* At least one RAI-avid lesion identified on the most recent radioiodine scan (a diagnostic, post-therapy, or post-ablation scan) OR at least one lesion on the most recent FDG PET scan with an SUV max of 10 or less. (Both RAI-sensitive and RAI-refractory patients are eligible if at least one tumor with RAI avidity of any degree can be identified within one of these parameters.)
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. Tumors in previously irradiated fields may be considered measureable if there is evidence of tumor progression after radiation treatment.
* ECOG Performance Status (PS) 0 or 1. (or Karnofsky ≥60%)
* Age ≥ 18 years at time of study entry
* Adequate normal organ and marrow function as defined below:
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (\> 1500 per mm\^3)
* Platelet count ≥ 100 x 10\^9/L (\>100,000 pe…
What they're measuring
1
Number of Patients With Dose-Limiting Toxicity (DLTs)
Timeframe: 6 weeks beginning from the first durvalumab