Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03204812|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma Prostate Adenocarcinoma Prostate Carcinoma Metastatic in the Bone 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 8 hours and durvalumab IV over 8 hours 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)|
|Estimated Enrollment :||27 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|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Treatment (tremelimumab, durvalumab)
Patients receive tremelimumab IV over 8 hours and durvalumab IV over 8 hours 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.
- Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 [ Time Frame: Up to 12 months ]
- Prostate-specific antigen (PSA) progression-free survival [ Time Frame: Up to 12 months ]The association between CD3 change and PSA PFS will be explored with a Cox model with CD3 as a continuous measure.
- Radiographic PFS [ Time Frame: Up to 12 months ]Radiographic PFS will start at the first day of treatment and will be summarized by Kaplan-Meier.
- Time to maximal PSA decline [ Time Frame: Up to 12 months ]Time to maximal 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.
- Immunological changes in peripheral blood and tissue [ Time Frame: Baseline up to 12 months ]For continuous data, summary statistics including n, mean, standard deviation, median, minimum and maximum or interquartile range (IQR) will be computed. Prostatic T cell infiltration pre-and-post biopsy will be described and graphed over time. Differences in either time point compared to baseline will be compared with a t-test or non-parametric alternative. Cox models will be implemented to explore the relationship of treatment combination, prostatic T cell infiltration, and PFS.
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|