Vidutolimod (CMP-001) in Combination With Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria

• •Male \>= 18 years of age
• •Histologically confirmed adenocarcinoma of the prostate with metastatic disease
• •Subjects who are refractory to a novel antiandrogen therapy (abiraterone, darolutamide, enzalutamide and/or apalutamide) and have failed at least 1 taxane based chemotherapy regimen (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen)
• •Prior orchiectomy or serum testosterone levels \< 50 ng/dL determined within 4 weeks prior to start of study drug
• •Having measurable disease per RECIST 1.1 (at least one additional lesion \>= 0.5 cm amenable to repeated IT injection per investigator)
• •Eastern Cooperative Oncology Group performance status of 0 or 1
• •Neutrophil count \>= 1,000/mm\^3 (within 4 weeks prior to the first dose of CMP-001)
• •Platelet count \>= 100,000/mm\^3 (within 4 weeks prior to the first dose of CMP-001)
• •Hemoglobin concentration \>= 9 g/dL (within 4 weeks prior to the first dose of CMP-001)
• •Total bilirubin =\< 1.5 times the upper limit of normal (ULN) with the following exception: subjects with Gilbert Disease serum bilirubin \>= 3 times ULN (within 4 weeks prior to the first dose of CMP-001)
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 times the ULN or =\< 5 times the ULN for patients with active liver metastases (within 4 weeks prior to the first dose of CMP-001)
• •Serum creatinine =\< 1.5 times the ULN or calculated creatinine clearance \>= 40 mL/min (\>= 0.67 mL/sec) using the Cockcroft-Gault equation (within 4 weeks prior to the first dose of CMP-001)
• •Subjects should have an international normalized ratio (INR) or a partial thromboplastin time (PTT) =\< 1.5 x ULN unless the subject is receiving anticoagulant therapy (within 4 weeks prior to the first dose of CMP-001). Subjects on anticoagulant therapy should have a prothrombin time (PT) or PTT within therapeutic range of intended use and no history of severe hemorrhage. Patients who require therapeutic anticoagulation and cannot discontinue anticoagulation safely during the day prior, day of, and day after injection are excluded. Patients requiring anticoagulation with warfarin are excluded unless they can be transitioned to an alternative anticoagulant (e.g., low molecular weight heparin or direct oral anticoagulants) prior to enrollment. Antiplatelet agents (e.g., aspirin, clopidogrel, etc.) are not considered anticoagulants for the purposes of this study (i.e., they are allowed)
• •Willingness to provide pre- and post-treatment fresh tumor biopsies, if safe and medically feasible
• •Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of CMP-001
• •Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
• •Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer \>= 2 weeks before the start of study therapy. (No radiotherapy to CMP-001 injection site within 4 weeks)
• •Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation