Study on Lenvatinib and Pembrolizumab for Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers

Inclusion Criteria

• For ACC patients: Must have confirmed adenoid cystic carcinoma, even if it started outside the salivary glands.
• For non-ACC patients: Must have confirmed salivary gland cancer of any type, except adenoid cystic carcinoma.
• Cancer must have returned or spread and cannot be treated with other curative therapies.
• At least 4 weeks must have passed since the last treatment, with recovery from any side effects.
• Must have measurable disease as defined by specific medical criteria.
• Must have a new or worsening tumor or symptoms within 6 months before joining the study.
• Must be 18 years or older.
• Must be in good general health, with a performance status score of 0 or 1.
• Must have tissue samples from the primary tumor or metastases available for study.
• Must meet specific blood test criteria for neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, and kidney function.
• Must agree to use effective contraception during and after the study.
• Must be able to swallow pills or have a feeding tube.

Exclusion Criteria

• Untreated brain metastases, unless stable and not requiring steroids.
• Receiving other cancer treatments, except for certain bone treatments or palliative radiation.
• Recent history of another cancer, unless treated over 2 years ago or certain skin cancers.
• Allergies to study drugs or their components.
• Previous treatment with lenvatinib or similar drugs.
• Uncontrolled high blood pressure.
• Recent use of other cancer treatments or investigational drugs.
• Significant protein in urine.
• Conditions affecting drug absorption.
• Recent serious heart problems.
• Recent blood clots or strokes.
• Prolonged QT interval on ECG.
• Recent severe bleeding.
• Active infections requiring treatment.
• Positive for HIV, active hepatitis B or C.
• Serious non-healing wounds or fractures.
• History of organ or tissue transplants.
• Recent use of certain growth factors.
• Medical conditions that could interfere with the study.
• Recent use of immunosuppressive drugs.
• Active autoimmune diseases requiring treatment.
• History of lung diseases or pneumonitis.
• Recent lung infections with lasting effects.
• Recent major surgery without adequate healing.
• Preexisting severe fistulas.
• Tumors involving major blood vessels.