🏛️ Verified NIH Record • Updated 2025-10-06

Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers (NCT04209660)

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

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (27 items) and avoid the listed exclusions (33 items).

Location: Baptist Alliance MCI — Miami, Florida

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Untreated metastatic brain (subjects with treated brain metastases will be eligible, provided that they are radiographically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment).
  • Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery, immunotherapy, biologic therapy or tumor embolization) other than study treatment. Concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed, provided they are started prior to study entry. Palliative radiation to non-target lesions is also allowed.
  • Prior malignancy if diagnosed and treated within 2 years of trial drug initiation (with the exception of non-melanomatous skin cancers). Patients may be included if they have completed therapy for a prior malignancy \>2 years prior to drug initiation and are currently NED. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (breast DCIS, or cervical CIS) that have undergone potentially curative at any time therapy are not excluded from trial participation.
  • History of allergy or intolerance to study drug components (or any of their excipients), or severe (\> Grade 3) hypersensitivity reaction to any excipients of pembrolizumab or any monoclonal antibody.
  • Prior use of lenvatinib or any PD-1/PD-L1 or anti-PD-L2 targeted therapies or with an agent directed at another stimulatory or co-inhibitory T-cell receptor (CTLA-4, OX-40, CD137).
  • Uncontrolled hypertension (systolic pressure \>140mm Hg or diastolic pressure \>90mm Hg), despite optimal medical management.
  • Prior systemic anti-cancer therapy including use of another investigational drug or device (i.e., outside study treatment) during, or within 4 weeks of trial entry (time of initiation of experimental drug).
  • Clinically significant proteinuria: °Subjects having \>1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with proteinuria ≥1gm/24-hour will be ineligible.
  • Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
  • New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months (baseline echocardiogram is not required unless clinically indicated).
  • Subjects with thrombotic, embolic, venous or arterial events, such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis or pulmonary embolism within 6 months of study treatment start.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

  • Baptist Alliance MCI — Miami, Florida
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey
  • Memorial Sloan Kettering Commack (All Protocol Activities) — Commack, New York
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Adenoid Cystic Carcinoma

Explore by condition: All Adenoid Cystic Carcinoma clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗