Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Adenoid Cystic

Salivary Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Adenocarcinoma

Adenoid Cystic Carcinoma

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

All eligible patients will undergo informed consent and screening for trial enrollment.

Enrolled patients will receive a starting lenvatinib dose of 20mg daily taken orally and pembrolizumab 200mg intravenously every 3 weeks (1 cycle=3 weeks)

Lenvatinib 20mg daily (two 10mg lenvatinib capsules) taken orally will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day.

Pembrolizumab (200mg) will be administered as a 30-minute IV infusion, Q3W +/-3 days (infusions lasting between 25-40 minutes are acceptable on C1D1.

Alan Ho, MD, PhD

David Pfister, MD

Guilherme Rabinowits, MD

Alan Ho, MD. PhD

The purpose of this study is to see if the study drugs, lenvatinib and pembrolizumab, are effective in treating advanced Adenoid Cystic Carcinoma (ACC) or other salivary gland cancers that have come back and/or spread to other parts of the body. Researchers are also doing this study to test the safety of the study drugs in participants.

This is a phase II study evaluating the efficacy of lenvatinib plus pembrolizumab in the treatment of progressive, recurrent/metastatic adenoid cystic carcinoma (R/M ACC) and recurrent/metastatic non-ACC salivary gland cancers (R/M SGC). Patients will be enrolled in two cohorts: Cohort 1, patients with R/M ACC ("ACC group"), and Cohort 2: patients with R/M SGC ("non-ACC group").

Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers

A Phase II Study of Lenvatinib Plus Pembrolizumab in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma and Other Salivary Gland Cancers

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

Merck Sharp & Dohme LLC

Eisai Inc.

Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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