This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle
Carotuximab administered intravenously at the following doses: Cycle 1 Day 1: 3 mg/kg Cycle 1 Day 4: 7 mg/kg Cycle 1 Day 8: 10 mg/kg Cycle 1 Day 15: 10 mg/kg Cycle 1 Day 22: 10 mg/kg Cycle 2 Day 1: 15 mg/kg Cycle 2 Day 15: 15 mg/kg Cycle 3+ Day 1: 15 mg/kg After completion of cycle 2, dosing of carotuximab will continue at a q4 week schedule using the 15 mg/kg dose.
City of Hope
Duarte, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGHuntsman Cancer Institute and Hospital
Salt Lake City, Utah, United States
RECRUITINGProgression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.
Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide
Grade 3 or above treatment related adverse events as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From start of study treatment through 4 weeks on treatment
Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab
Participants of the combination of apalutamide + carotuximab, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3
Time frame: From the start of combination study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
Proportion of patients resistant to apalutamide benefit from the addition of carotuximab
Participants of the monotherapy group that crossover to combination therapy at progression, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3
Time frame: From the start of combination therapy study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
Overall radiographic response rate (ORR) in the overall population
Determined by confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3
Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
To determine the radiographic progression free survival (rPFS) in the overall population
From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.
Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
To determine the biochemical PFS (by PCWG3) in the overall population
From the start of study treatment until documented progression, per Prostate Cancer Working Group 3, or death due to any cause.
Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
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