REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03951831|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic||Drug: REGN2810 Drug: Degarelix Drug: Leuprolide Acetate Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
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
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
- 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.
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): NCT03951831
|Contact: Lisa Olmos, RNfirstname.lastname@example.org|
|Contact: Mark Stein, MD||(212) email@example.com|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Mark Stein, MD firstname.lastname@example.org|
|Principal Investigator: Mark Stein, MD|
|Principal Investigator:||Mark Stein, MD||Associate Professor of Medicine|