Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer Metastatic | Drug: REGN2810 Drug: Degarelix Drug: Leuprolide Acetate Drug: Docetaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II, Open-label, Single-center Study Evaluating Safety and Activity of Androgen Deprivation Therapy Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (mHSPC) |
Estimated Study Start Date : | May 2019 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
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Experimental: ADT Followed by Chemoimmunotherapy
REGN2810 followed by chemoimmunotherapy: Initiate degarelix 240mg SC once, followed by leuprolide acetate 22.5mg SC every 3 months. Week 4 start cemiplimab (REGN 2810) 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease. Week 10 start docetaxel 75 mg/m2 every 21 days for up to 6 cycles. |
Drug: REGN2810
Cemiplimab (REGN 2810) is administered starting at week 4 at a dose of 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease.
Other Name: Cemiplimab
Drug: Degarelix Degarelix is administered subcutaneously (SC) at a dose of 240mg once.
Other Name: Firmagon
Drug: Leuprolide Acetate Leuprolide acetate is provided at a dose of 22.5mg SC every 3 months.
Other Name: Lupron
Drug: Docetaxel Docetaxel is administered starting at week 10 at a dose of 75 mg/m2 every 21 days for up to 6 cycles.
Other Name: Taxotere
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have adequate organ and marrow function as defined below:
Exclusion Criteria:
The subject must be excluded from participating in the trial if the subject:
Contact: Lisa Olmos, RN | 212-342-5162 | cancerclinicaltrials@cumc.columbia.edu | |
Contact: Mark Stein, MD | (212) 304-5558 | mns2146@cumc.columbia.edu |
United States, New York | |
Columbia University Irving Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Mark Stein, MD mns2146@cumc.columbia.edu | |
Principal Investigator: Mark Stein, MD |
Principal Investigator: | Mark Stein, MD | Associate Professor of Medicine |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 14, 2019 | ||||||
First Posted Date ICMJE | May 15, 2019 | ||||||
Last Update Posted Date | May 15, 2019 | ||||||
Estimated Study Start Date ICMJE | May 2019 | ||||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Percentage of Subjects Achieving Undetectable PSA at 6 months after Combination Treatment [ Time Frame: 6 months ] The percentage of subject achieving undetectable PSA levels at 6 months after the combination will use measured to determine safety and activity of combined hormonal chemoimmunotherapy.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer | ||||||
Official Title ICMJE | Phase II, Open-label, Single-center Study Evaluating Safety and Activity of Androgen Deprivation Therapy Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | ||||||
Brief Summary | The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint of undetectable prostate-specific antigen (PSA) at 6 months, defined from start of combination therapy (week 10) until 6 months (week 37). | ||||||
Detailed Description | The slow progress for notable trials in metastatic, hormone-sensitive disease is attributed to the long duration of follow-up required, as well as the focus on time-to-event end points, i.e. overall survival, in clinical trial design. These landmark trials (CHAARTED, STAMPEDE, LATITUDE), which used overall survival as their endpoints, required, on average, 10 years from start of trial to first peer-reviewed publication. Given the challenge of using traditional measures of response (RECIST criteria) when designing prostate cancer clinical trials, the Prostate Cancer Working group 2 (PCWG2) made trial-design recommendations. One was to separate treatment outcomes into early measures of response and later time-to-event measures of progression. The goal is to shift the trial objective to capture and reflect the actual effect of the tested treatment and, in doing so, provide a more timely drug development milieu for the metastatic patient. These early measure of response end points, such as undetectable PSA with testosterone recovery, are now being actively integrated into clinical trial design. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer Metastatic | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: ADT Followed by Chemoimmunotherapy
REGN2810 followed by chemoimmunotherapy: Initiate degarelix 240mg SC once, followed by leuprolide acetate 22.5mg SC every 3 months. Week 4 start cemiplimab (REGN 2810) 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease. Week 10 start docetaxel 75 mg/m2 every 21 days for up to 6 cycles. Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 2020 | ||||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: The subject must be excluded from participating in the trial if the subject:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03951831 | ||||||
Other Study ID Numbers ICMJE | AAAS1863 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mark Stein, Columbia University | ||||||
Study Sponsor ICMJE | Mark Stein | ||||||
Collaborators ICMJE | Regeneron Pharmaceuticals | ||||||
Investigators ICMJE |
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PRS Account | Columbia University | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |