Lenvatinib + Pembrolizumab for Salivary Gland Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Alan L Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing lenvatinib and pembrolizumab in patients with advanced Adenoid Cystic Carcinoma or other salivary gland cancers that have come back or spread. Lenvatinib stops cancer cells from growing, while pembrolizumab helps the immune system attack the cancer. Researchers aim to see if these drugs are effective and safe for these patients. Lenvatinib and pembrolizumab have shown promising results in treating various advanced cancers, including thyroid, liver, endometrial, and gastric cancers.

Eligibility Criteria

Adults with advanced Adenoid Cystic Carcinoma or other salivary gland cancers that have returned or spread, who've had no recent treatments causing unresolved side effects. They must be able to swallow pills (or have a G-tube), not be pregnant or breastfeeding, and agree to use contraception. Participants need measurable disease and available tumor tissue for study.

Inclusion Criteria

I am 18 years old or older.

I can swallow pills or have a working G-tube.

My cancer can be measured by scans and has grown despite previous treatments.

Exclusion Criteria

I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

I have not received a live vaccine within the last 30 days.

I have or had lung inflammation that needed steroids.

Participant Groups

The trial is testing the effectiveness and safety of lenvatinib combined with pembrolizumab in treating advanced salivary gland cancers. It aims to determine if these drugs can help control the cancer when it has recurred or spread elsewhere in the body.

Group I: recurrent/metastatic non-ACC salivary gland cancers (R/M SGC). Experimental Treatment 2 Interventions

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)

Group II: recurrent/metastatic adenoid cystic carcinoma (R/M ACC) Experimental Treatment 2 Interventions

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 is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Lenvima for:

• Differentiated Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

🇪🇺 Approved in European Union as Lenvima for:

• Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

🇪🇺 Approved in European Union as Kisplyx for:

• Renal Cell Carcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Baptist Alliance MCI Miami, FL

National Institute of Health (Data Collection AND Specimen Analysis) Bethesda, MD

Memorial Sloan Kettering Bergen (All Protocol Activities) Montvale, NJ

Memorial Sloan Kettering Westchester (All Protocol Activities) West Harrison, NY

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

Eisai Inc. Industry Sponsor

Merck Sharp & Dohme LLC Industry Sponsor

References