M7824 in People With Recurrent Respiratory Papillomatosis

• INCLUSION CRITERIA:

Recurrent Respiratory Papillomatosis (RRP) criteria:

• Histological diagnosis of RRP confirmed by pathology report from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
• One of the following:
• A Derkay anatomic score of 10 or greater and a history of two or more endoscopic interventions in the last 12 months for control of RRP.
• Pulmonary RRP with pulmonary disease that is measurable by computed tomography scan and evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.
• Tracheal involvement with RRP that has required either two or more endoscopic interventions in the last 12 months or a tracheostomy.
• Greater than or equal to 18 years of age.
• Able to understand and sign the Informed Consent Document.
• Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
• Willing to undergo endoscopic evaluation with biopsies in compliance with this protocol.
• No systemic therapy for RRP for at least 3 half-lives of the prior drug(s).
• Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to first dose:
• White Blood Count (WBC) > 2000/ microliter
• Neutrophils > 1000/ microliter
• Platelets > 75 x10(3)/ microliter
• Hemoglobin > 9.0 g/dL
• Serum Creatinine 30 mL/min (measured or calculated using the Modification of Diet in Renal Disease (MDRD) equation).
• Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) less than or equal to 2.5 x ULN
• Total Bilirubin: 1.5 x ULN
• Prothrombin time (PT)/International Normalized Ratio (INR) and partial thromboplastin time (PTT) less than or equal to ULN
• Sexually active subjects (men and women) of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method throughout M7824 treatment and for at least 120 days after M7824 treatment. Highly Effective Methods are defined as: Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation and partner s vasectomy; Other are defined as: latex condom, diaphragm and cervical cap.
• Seronegative for human immunodeficiency virus (HIV) antibody. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune function and thus are likely less responsive to the experimental treatment.
• Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests (Hep B Deoxyribonucleic acid (DNA) Quant, hepatitis B virus (HBV) Viral Load), and if confirmatory tests are negative, the patient can be enrolled.
• Seronegative for hepatitis C antibody unless antigen negative. If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by Hep C Ribonucleic acid (RNA) Quant, hepatitis C virus (HCV) Viral Load and be HCV RNA negative.

EXCLUSION CRITERIA

• Any severe acute or chronic medical or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, liver disease, lung disease (with the exception of what is specified in inclusion criteria) , or laboratory abnormalities that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study. Patients with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) well controlled with oral or inhaled medications are permitted to enroll.
• Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, or psoriasis not requiring systemic treatment, are permitt