CT821: This phase I trial is evaluating two drugs (MEDI94 and MEDI4736) alone and in combination for the treatment of adult patients with select solid cancersA Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

Exclusion

• Prior treatment with tumor necrosis factor receptor superfamily agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, PD-L1, and anti PD-L1.
• Participants who have received prior therapy with regimens containing CTLA-4, PD-L1, or PD-1 antagonists may be permitted to enroll under certain conditions

• Cardiac or peripheral vascular disease meeting any of the following criteria:

  • Past history of myocardial infarction in the prior 12 months
  • Past history of stroke or transient ischemic attack requiring medical therapy
  • Congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification
• Grade 3 or greater edema (eg, peripheral, pulmonary)
• History of Grade 3 or greater thromboembolic events in the prior 12 months
• Participants with active tuberculosis are ineligible. In settings where there is clinical or radiographic evidence of tuberculosis, active disease must be ruled out
• Active or prior documented autoimmune or inflammatory disorders
• Untreated central nervous system (CNS) metastatic disease
• Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
• Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, uncontrolled hypertension, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirement