Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04926181|
Recruitment Status : Not yet recruiting
First Posted : June 15, 2021
Last Update Posted : October 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Neuroendocrine Carcinoma Prostate Cancer Small Cell Carcinoma||Drug: Apalutamide Biological: Cetrelimab||Phase 2|
This is a phase 2, single arm, Simon's two-stage evaluation of the combination of apalutamide plus cetrelimab in patients with mCRPC and histologic and/or genomic evidence of treatment-emergent small cell neuroendocrine prostate cancer who have previously progressed on at least one prior androgen signaling inhibitor.
Participants may continue study treatment from the time of treatment initiation until confirmed radiographic progressive disease (PD) per PCWG3 and RECIST 1.1 criteria, unequivocal clinical progression, unacceptable toxicity, or patient withdrawal, whichever occurs first, for a maximum of 24 months.
I. To determine the composite response rate as defined by achieving one or more of the following at any time point during study treatment:
- Decline from baseline in serum PSA of >= 50% (PSA50), confirmed by repeat measurement >= 4 weeks later and/or
- Objective response by RECIST 1.1 criteria
I. To determine safety of the combination as determined by CTCAE version 5.0.
II. To determine the median radiographic progression-free survival by PCWG3 criteria.
III. To determine the PSA50 and decline from baseline in serum PSA of >= 90% (PSA90) response proportion achieved.
IV. To determine the median PSA progression-free survival.
V. To determine the median overall survival.
VI. To determine the objective response rate and median duration of response by RECIST 1.1 criteria.
Patients will be followed up for safety evaluations 30 days and 100 days after treatment completion. Patients will be followed for overall survival every 90 days (+/- 30 days) from last dose of study treatment, until death, withdrawal of consent, or the end of the study, whichever occurs first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer|
|Estimated Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||May 31, 2025|
|Estimated Study Completion Date :||May 31, 2026|
Experimental: Single Arm: Apalutamide + Cetrelimab
Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
240 mg once daily, for a 28 day cycle
480 mg given through intravenous infusion (IV) on day 1 of every 28-day treatment cycle and administered over a 60-minute infusion
- Composite Response Rate [ Time Frame: Up to 2 years ]The composite response rate is determined by a combination of a decline from baseline in serum PSA of >= 50%, confirmed by repeat measurement ≥ 4 weeks later (PSA50) AND/OR a complete response (CR) or partial response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
- Proportion of participants with treatment-related Adverse Events (AEs) [ Time Frame: Up to 2 years ]Proportion of participants with an adverse event determined to be related to study treatment, and classified using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0)
- Median radiographic progression free survival (PFS) [ Time Frame: Up to 2 years ]PFS is defined as the time from initiation of study treatment until radiographic progression by PCWG3 criteria or death, whichever occurs first.
- Proportion of participants with a >=50% decline in PSA [ Time Frame: Up to 2 years ]Defined as the proportion of participants with a demonstrated >= 50% decline from baseline serum PSA confirmed by repeat measurement >= 4 weeks after first time point.
- Proportion of participants with a >=90% decline in PSA [ Time Frame: Up to 2 years ]Defined as the proportion of participants with a demonstrated >= 90% decline from baseline serum PSA confirmed by repeat measurement >= 4 weeks after first time point.
- Median PSA progression-free survival (PFS) [ Time Frame: Up to 2 years ]PSA progression-free survival is defined as the time from initiation of study treatment until PSA progression as determined by PCWG3 criteria or death, whichever occurs first.
- Median Overall Survival [ Time Frame: Up to 3 years ]Overall survival from date of initiation of study treatment until death from any cause.
- Objective Response Rate [ Time Frame: Up to 2 years ]From initiation of study treatment until maximal percent decline from baseline in sum of longest diameter (SLD) of target lesions by RECIST 1.1 criteria
- Median Duration of Response [ Time Frame: Up to 2 years ]The length of time from a confirmed response until progression or death, whichever comes first.
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): NCT04926181
|Contact: UCSF Genitourinary Medical Oncology Recruitment||877-827-3222||GUTrials@ucsf.edu|
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Contact: UCSF Genitourinary Medical Oncology Recruitment GUTrials@ucsf.edu|
|Contact 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Rahul Aggarwal, MD|
|Principal Investigator:||Rahul Aggarwal, MD||University of California, San Francisco|