Pembrolizumab in High-risk Thyroid Cancer
ConditionDifferentiated Thyroid Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Poorly differentiated carcinoma; Hurtle cell carcinoma.
Patients with distant metastasis at diagnosis.
Disqualifiers
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).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pembrolizumab
DrugNeoadjuvant pembrolizumab 200mg Q3W will be administered via IV infusion for 2 courses from the date of randomization until to the date of thyroidectomy.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: experimental arm AExperimental treatment 1 intervention
Group B: control group BNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
To investigate the behavior of exhausted cytotoxic T cell (CD8+ T) in tumor tissue in response to pembrolizumab
Relative proportion of exhausted CD8+ T cells and their topological relationships to cell clusters in TCs following neoadjuvant pembrolizumab assessed by "Spatial-transcriptomic" sequencing
Time frame
Up to 12 months after surgery2
To investigate the behavior of exhausted cytotoxic T cell (CD8+ T) at circulating level in response to pembrolizumab
Relative proportion of exhausted CD8+ T cells and their topological relationships to cell clusters in TCs following neoadjuvant pembrolizumab assessed by single-cell sequencing
Time frame
Up to 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov