Vudalimab in Combination with Standard of Care Treatment in Patients with Metastatic Castration Sensitive Prostate Cancer
Prostate Cancer
Unknown Primary
WINSHIP5741-22 (primary)
NCI-2023-00171
STUDY00004688
Summary
This phase I trial tests the safety and effectiveness of vudalimab in combination with standard of care treatment abiraterone, enzalutamide and docetaxel in treating patients with castration sensitive prostate cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding vudalimab to standard of care treatments may be effective in treating metastatic castration sensitive prostate cancer.
Objectives
PRIMARY OBJECTIVE:
I. To determine the safety and tolerability of vudalimab (XmAb20717) in combination with standard of care treatment in subjects with metastatic castration sensitive prostate cancer (mCSPC) as assessed by frequency and intensity of adverse events.
SECONDARY OBJECTIVE:
I. To assess the preliminary antitumor activity of XmAb20717 with standard of care treatment.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To identify factors that may be indicative of response to XmAb20717 in combination with standard of care treatments.
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT A: Patients receive vudalimab intravenously (IV) on days 1 and 15 plus abiraterone orally (PO) once daily (QD) of 4-week cycles on study. Patients also undergo prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and fludeoxyglucose (FDG) PET scans during screening. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) scans, bone scans, and blood sample collection throughout the study.
COHORT B: Patients receive vudalimab IV on days 1 and 15 plus enzalutamide PO QD of 4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.
COHORT C: Patients receive vudalimab IV on days 1 and 15, docetaxel IV on days 1 and 22 plus abiraterone PO QD of 6-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.
Eligibility
- Age >= 18 years
- Histologically confirmed adenocarcinoma of the prostate with metastatic disease
- Castration-sensitive status: either not have been treated with androgen deprivation therapy (ADT) (hormone therapy) or not on ADT at the time of progression
* Participants can have received up to 3 months of ADT with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists or orchiectomy with or without concurrent first-generation antiandrogens prior to enrollment, with no radiographic evidence of disease progression or rising prostate-specific antigen (PSA) prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Life expectancy > 12 weeks as determined by the investigator
- Hemoglobin >= 9.0 g/dl (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of Cycle 1 Day 1 to meet entry criteria)
- White blood cell (WBC) >= 2000/uL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion)
- Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion)
- Platelets >= 100,000/mcL (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria)
- Prothrombin time (PT)/ partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Total bilirubin =< 1.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 3 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28 days of cycle 1 day 1)
- 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 Xmab27017
- 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 surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy for the treatment of cancer >= 2 weeks before the start of study therapy. (No radiotherapy to Xmab27017 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
Treatment Sites in Georgia
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