Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03204812|
Recruitment Status : Completed
First Posted : July 2, 2017
Results First Posted : May 25, 2022
Last Update Posted : May 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Castration-Resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Bone Prostate Adenocarcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Biological: Durvalumab Biological: Tremelimumab||Phase 2|
I. To evaluate the safety and tolerability of durvalumab plus tremelimumab in patients with metastatic castration-resistant prostate cancer.
I. To assess the efficacy of durvalumab plus tremelimumab in patients with metastatic castration-resistant prostate cancer. II. To explore immunological changes in peripheral blood and tissue (e.g. peripheral blood cluster of differentiation [CD] 4+ [Inducible COStimulator (ICOS)]+ T cells, CD3 expression in tissue) in response to durvalumab plus tremelimumab in patients with metastatic castration-resistant prostate cancer.
Patients receive tremelimumab intravenously (IV) over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30, 60, and 90 days, and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial to Explore the Link Between Immunological Changes, Efficacy, Safety, and Tolerability of Durvalumab (MEDI4736) Plus Tremelimumab in Chemotherapy-Naïve Men With Metastatic Castration-Resistant Prostate Cancer (CRPC)|
|Actual Study Start Date :||July 14, 2017|
|Actual Primary Completion Date :||April 13, 2021|
|Actual Study Completion Date :||April 13, 2021|
Experimental: Treatment (tremelimumab, durvalumab)
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
- Number of Adverse Events [ Time Frame: from date of the first treatment, up to 43.6 months ]Toxicity will be monitored in all patients who receive at least one dose of tremelimumab, even if the patient is not evaluable for the biomarker or efficacy endpoint. Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03.
- Prostate-specific Antigen (PSA) Progression Free Survival (PFS) [ Time Frame: from the first day of treatment, up to 43.6 months ]PSA PFS is defined as per Prostate Cancer Working Group 3 (PCWG3) criteria: time from start of therapy to first PSA increase of 25% and ≥2 ng/mL above the nadir, and which is confirmed by a second value ≥3 weeks later. PSA PFS were calculated from the first day of treatment and summarized by Kaplan-Meier methods.
- Radiographic Progressive Free Survival (rPFS) [ Time Frame: from first day of treatment, up to 43.6 months ]rPFS is measured from first dose to date of disease progression on CT and/or bone scan or death from any cause, whichever occurs first. Radiographic PFS will start at the first day of treatment and will be summarized by Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),as a 20% increase in the sum of the longest diameter of target lesions, or ameasurable increase in a non-target lesion, or the appearance of new lesions
- Number of Participants With PSA Decline of ≥50% From Start of Therapy [ Time Frame: baseline, up to 43.6 months ]PSA decline will start at the first day of treatment and will be summarized by Kaplan-Meier. The numeric PSA value at maximal decline will be summarized by a boxplot and as a scatter plot of maximal decline by baseline PSA. PSA is produced by normal and cancerous prostate tissue. PSA levels are often elevated in men with prostate cancer.
- Median Overall Survival [ Time Frame: from start of treatment, up to 43.6 months ]Overall Survival is the time which begins at diagnosis (or at the start of treatment) and up to the time of death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204812
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sumit K Subudhi||M.D. Anderson Cancer Center|