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Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

ConditionAnaplastic Thyroid Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Petersburg State University, Russia

About this trial

This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

immunohistochemically verified anaplastic thyroid cancer that is not eligible to R0-R1 surgery;

age ≥ 18 years;

functional status of ECOG 0-2;

adequate function of internal organs and bone marrow;

Disqualifiers

patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors;

patients with clinically significant hemoptysis and bleeding (for example, from the gastrointestinal tract or tumor-associated bleeding);

tumor invasion into large vessels;

patients with open wounds and fistulas;

Trial design

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab + Lenvatinib

    Drug

    Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody. Lenvatinib is Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

The proportion of participants with a partial or complete response to the therapy. It is determined according to the iRECIST criteria.

Time frame
Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
2

Progression-Free Survival

The time from the date of treatment initiation to the radiological progression or death of the patient for any reason.

Time frame
6-month, 1-year, 2-year
3

Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events)

Safety assessment will be assessed on the basis of adverse events (according to CTCAE 5.0)

Time frame
Each visit (every 21 days) assessed up to 48 months

Secondary outcomes

1

Overall survival

The time from the start date of treatment to the death of the patient for any reason.

Time frame
6-month, 1-year, 2-year
2

The assessment of conversion to resectability

The proportion of participants with an initially unresectable or potentially resectable tumor who have moved to a resectable during treatment.

Time frame
Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint Petersburg State University, Russia

Lead sponsor

Source ClinicalTrials.gov
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