Comparing 17 approaches for solid tumors

Exclusion

• −There are no exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → to participate in MK-3475-587.
• −Participants are excluded from entering Second Course trial treatment once they are enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → on MK-3475-587 if any of the following criteria applies:
• −Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → for hepatitis.
• −Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
• −Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.
• −Has a known history of human immunodeficiency virus (HIV) infection.
• −Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
• −Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.
• −Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
• −Has known active central nervous system metastases and/or carcinomatous meningitis.
• −Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• −Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
• −Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
• −Has an active infection requiring systemic therapy.
• −Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
• −Has hepatic decompensation (Child-Pugh score \>6 \[class B and C\]).
• −Has uncontrolled thyroid dysfunction.
• −Has uncontrolled diabetes mellitus.
• −Has had an allogeneic tissue/solid organ transplant.
• −Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
• −Additional exclusion criteria for participants who enter dosing with Lenvatinib:
• −Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
• −Has urine protein ≥1 g/24 hours.
• −Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
• −Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
• −Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms.
• −Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
• −Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
• −Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
• −Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
• −Has had major surgery within 3 weeks prior to first dose of study intervention(s).