At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 57 enrolled

Drug / intervention

Lenvatinib +3 moredrug

Likely dose

Lenvatinib and pembrolizumab IV (specific doses not stated in criteria or arms)AI-extracted

Key inclusion· 6

✓Locally recurrent unresectable and/or metastatic differentiated thyroid cancer (papillary, follicular, poorly differentiated variants) confirmed histologically or cytologically
✓Radioiodine-refractory disease: measurable lesions without RAI uptake, progressive ≤14 months after RAI, or persistent after ≥600 mCi cumulative dose, or FDG-avid (>5 SUV)
✓Measurable disease ≥1.0 cm (non-lymph node) or ≥1.5 cm short-axis (lymph node); if single non-lymph lesion must be ≥1.5 cm; post-EBRT/RF ablation lesions must show progressive disease per RECIST 1.1
✓Cohort 1: Disease progression ≤14 months prior to registration per RECIST 1.1; Cohort 2: Progressive disease on lenvatinib ≤60 days prior to registration with imaging within 30 days of pembrolizumab start

Key exclusion· 10

✕Cohort 1: prior treatment with VEGFR-active multikinase inhibitor; Cohort 2: discontinued lenvatinib due to toxicity or >1 prior VEGFR inhibitor
✕Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
✕Active CNS metastases or carcinomatous meningitis (stable treated brain metastases allowed if stable ≥4 weeks, no progression, no steroids ≥7 days)
✕Immunocompromised, HIV+ on antiretroviral therapy, or known active TB

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02973997

NCT02973997Phase 2Completed

Compare CT.gov

Combination Targeted Therapy With Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers: A Phase II Study

Academic and Community Cancer Research United·interventional·Posted Nov 28, 2016·Updated Aug 29, 2025

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Lenvatinib, and 2 other interventions for Columnar Cell Variant Thyroid Gland Papillary Carcinoma and 25 related conditions. Completed, enrolled 57 participants across 7 sites.

Detailed Summary

This phase II trial studies how well pembrolizumab and lenvatinib work in treating patients with differentiated thyroid cancer that has spread to other places in the body or has come back and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished

2017201820192020202120222023202420252026

First PostedNov 2016

Enrollment StartFeb 2018

Primary CompletionAug 2022

Study CompletionOct 2023

TodayJul 2026

First PostedNov 28, 2016

Enrollment StartFeb 7, 2018

Primary CompletionAug 15, 2022

Study CompletionOct 8, 2023

TodayJul 2, 2026

Enrollment to primary: 4.5 yearsPosted 9.6 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Lenvatinibdrug

Given PO

Lenvatinib Mesylatedrug

Given PO

Pembrolizumabbiological

Given IV