Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

• Status: Terminated
• Trial end date: 2020-10-06
• Target enrollment: 0
• Participant gender: Male

Summary

This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

To be eligible for this study, patients must meet all of the following criteria:

• Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs

• Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥7

• Radical prostatectomy has been scheduled at Johns Hopkins Hospital

• Age ≥18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70%

• Adequate bone marrow, hepatic, and renal function:

• WBC >3,000 cells/mm3

• ANC >1,500 cells/mm3

• Hemoglobin >9.0 g/dL

• Platelet count >100,000 cells/mm3

• Serum creatinine <3 × upper limit of normal (ULN)

• Serum bilirubin <3 × ULN

• ALT <5 × ULN

• AST <5 × ULN

• Alkaline phosphatase <5 × ULN

• Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)

• Willingness to use barrier contraception from the time of first dose of DUPILUMAB until the time of prostatectomy.

Exclusion Criteria:

To be eligible for this study, patients should not meet any of the following criteria:

• Presence of known lymph node involvement or distant metastases

• Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors

• Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer

• Prior immunotherapy/vaccine therapy for prostate cancer

• Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors

• Current use of systemic corticosteroids or use of corticosteroids within 4 weeks of enrollment (inhaled corticosteroids for asthma or COPD are permitted)

• Use of experimental agents for prostate cancer within the past 3 months from time of screening

• History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren syndrome, and sarcoidosis)

• History of malignancy within the last 3 years, with the exception of non-melanoma skin cancers and superficial bladder cancer

• Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate

• Known prior or current history of HIV and/or hepatitis B/C

• Significant eye disease