Pembrolizumab in High-risk Thyroid Cancer (NCT05852223) | Clinical Trial Compass
RecruitingPhase 2
Pembrolizumab in High-risk Thyroid Cancer
Italy25 participantsStarted 2024-12-20
Plain-language summary
This window of opportunity trial is studying a checkpoint inhibitor agent to treat differentiated thyroid cancer in a neoadjuvant setting. A checkpoint inhibitor is a compound aimed at restoring tumor immunosurveillance. The name of this agent is pembrolizumab.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of differentiated thyroid carcinoma candidate to surgery not previously treated will be enrolled in this study.
✓. Patients with a risk \> 20% for persistent/recurrent disease: primary tumor \> 4 cm; multifocal papillary microcarcinoma with extra tumor extension (ETE) and known BRAF V600E mutation; clinical N1; gross ETE (macroscopic invasion of perithyroidal soft tissues); extranodal extension; expected incomplete tumour resection.
✓. Patients with distant metastasis at diagnosis.
✓. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
✓. Have measurable disease based on RECIST 1.1.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
✓. Have adequate organ function as defined in the following table (Table 2) Specimens must be collected within 10 days prior to the start of study treatment.
Exclusion criteria
✕. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
What they're measuring
1
To investigate the behavior of exhausted cytotoxic T cell (CD8+ T) in tumor tissue in response to pembrolizumab
Timeframe: Up to 12 months after surgery
2
To investigate the behavior of exhausted cytotoxic T cell (CD8+ T) at circulating level in response to pembrolizumab
✕. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
✕. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
✕. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ (eg, breast carcinoma or cervical cancer in situ that have undergone potentially curative therapy are not excluded).