A trial to find out if vidutolimod together with cemiplimab is safe and if it works in adult participants with advanced cancer or metastatic cancer

Prior treatment

• Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade ≤ 1 or at baseline) from radiation-related toxicities.
• Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 30 days before first dose of study treatment on W1D1, as defined in the protocol.
• History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody.
• Not fully recovered from AEs due to prior treatment (to Grade 1 or less, per Common Terminology Criteria for Adverse Events (CTCAE), with the exception of persistent vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency.

Other illness

• Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
• Active pneumonitis or history of noninfectious pneumonitis that required steroids
• Severe uncontrolled medical disease within 12 months of screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator, or emphysema with FEV1 ≤ 50% predicted.
• Known history of immunodeficiency.
• Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol.

Other

• NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
• Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).

• Histopathologically-confirmed diagnosis of cancer, as defined by the protocol
• Measurable disease, as defined by RECIST v1.1 and as defined in the protocol
• Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening
• Other protocol defined inclusion criteria apply