Acarbose in Combination With Standard Therapy in Metastatic Renal Cell Carcinoma (RCC)

Exclusion Criteria

• •1\. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization.
• •2\. Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment.
• •3\. Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to acarbose or investigators choice of standard of care therapy.
• •4\. Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization, except in the case of central nervous system (CNS) metastases.
• •5\. Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded.
• •6\. Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ are acceptable if they have undergone potentially curative therapy. Low grade prostate cancer with gleason score 6 or lower which is not under active therapy will be acceptable if in investigator judgement it is likely not a competing risk to patient's life expectancy.
• •7\. Has known active untreated CNS metastases and/or carcinomatous meningitis. 8. Has an active infection requiring systemic therapy. 9. Has received a live virus vaccine within 30 days of randomization. 10. Has a clinically significant gastrointestinal (GI) abnormality including Malabsorption, total gastric resection or any condition that might affect the absorption of orally taken medication.
• •11\. Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy 12. Has QT interval corrected for heart rate (QTc) ≥480 msec. 13. Has a history of any of the following cardiovascular conditions within 6 months of randomization: Myocardial infarction, Unstable angina pectoris Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association and Cerebrovascular accident or transient ischemic attack.
• •14\. Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg measured two times a day - despite the use of 3 or more antihypertensive medications.
• •15\. Has recorded hypoglycemic episodes with blood glucose \<60 mg/dL documented within the last 12 months.
• •16\. Has medication treated diabetes and HbA1c \< 8 gm/dL 17. Has hemoptysis within 6 weeks prior to randomization. 18. Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors.
• •19\. Has current use (within 7 days of randomization) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or drugs that are known with proarrhythmic potential.
• •20\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• •21\. Has had a prior solid organ transplant. 22. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.