NCT04209660

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Adenoid Cystic Carcinoma
• Salivary Gland Cancer

Interventions

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

Timeline

• Start date: 2020-06-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-12-24
• Last updated: 2025-10-07

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study