Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)

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.

Conditions

• Columnar Cell Variant Thyroid Gland Papillary Carcinoma
• Follicular Variant Thyroid Gland Papillary Carcinoma
• Metastatic Thyroid Gland Follicular Carcinoma
• Metastatic Thyroid Gland Papillary Carcinoma
• Poorly Differentiated Thyroid Gland Carcinoma
• Recurrent Differentiated Thyroid Gland Carcinoma
• Recurrent Thyroid Gland Follicular Carcinoma
• Recurrent Thyroid Gland Papillary Carcinoma
• Stage III Differentiated Thyroid Gland Carcinoma AJCC v7
• Stage III Thyroid Gland Follicular Carcinoma AJCC v7
• Stage III Thyroid Gland Papillary Carcinoma AJCC v7
• Stage IV Thyroid Gland Follicular Carcinoma AJCC v7
• Stage IV Thyroid Gland Papillary Carcinoma AJCC v7
• Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7
• Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7
• Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7
• Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7
• Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7
• Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7
• Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7
• Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7
• Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7
• Tall Cell Variant Thyroid Gland Papillary Carcinoma
• Thyroid Gland Hurthle Cell Carcinoma
• Unresectable Differentiated Thyroid Gland Carcinoma
• Unresectable Thyroid Gland Carcinoma

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lenvatinib

Given PO

DRUG

Lenvatinib Mesylate

Given PO

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Academic and Community Cancer Research United

  lead OTHER

Principal Investigators

• Bryan R Haugen · Academic and Community Cancer Research United

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-07

Primary Completion

2022-08-15

Completion

2023-10-08

FDA Drug

Yes

Countries

• United States

Study Locations