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Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Primary Purpose

Castration-resistant Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Apalutamide
Carotuximab
Sponsored by
Edwin Posadas, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Castration-resistant Prostate Cancer focused on measuring Prostate cancer, Castration-resistant, CRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs
  • Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.
  • Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.
  • All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab)

Exclusion Criteria:

  • Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise
  • Prior use of apalutamide
  • Other prior malignancy requiring active anticancer therapy
  • Prior exposure to carotuximab or any CD105 targeted antibody
  • Active bleeding or pathologic medical conditions that carries a high bleeding risk
  • A known diagnosis of Osler-Weber-Rendu syndrome

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Apalutamide monotherapy

Combination therapy (Apalutamide + Carotuximab)

Arm Description

After progression, subjects will crossover to combination therapy

Outcomes

Primary Outcome Measures

Radiographic progression 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.

Secondary Outcome Measures

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.
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
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
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
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.
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.

Full Information

First Posted
September 6, 2022
Last Updated
September 21, 2023
Sponsor
Edwin Posadas, MD
Collaborators
Enviro Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05534646
Brief Title
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Official Title
Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edwin Posadas, MD
Collaborators
Enviro Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-resistant Prostate Cancer
Keywords
Prostate cancer, Castration-resistant, CRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apalutamide monotherapy
Arm Type
Active Comparator
Arm Description
After progression, subjects will crossover to combination therapy
Arm Title
Combination therapy (Apalutamide + Carotuximab)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apalutamide
Intervention Description
Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Carotuximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiographic progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
Description
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.
Secondary Outcome Measure Information:
Title
Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide
Description
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
Title
Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab
Description
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.
Title
Proportion of patients resistant to apalutamide benefit from the addition of carotuximab
Description
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.
Title
Overall radiographic response rate (ORR) in the overall population
Description
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.
Title
To determine the radiographic progression free survival (rPFS) in the overall population
Description
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.
Title
To determine the biochemical PFS (by PCWG3) in the overall population
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide. Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician. All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab) Exclusion Criteria: Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise Prior use of apalutamide Other prior malignancy requiring active anticancer therapy Prior exposure to carotuximab or any CD105 targeted antibody Active bleeding or pathologic medical conditions that carries a high bleeding risk A known diagnosis of Osler-Weber-Rendu syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Recruitment Navigator
Phone
3104232133
Email
cancer.trial.info@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Posadas, MD FACP
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Recruitment Navigator
Phone
310-423-2133
Email
cancer.trial.info@cshs.org
First Name & Middle Initial & Last Name & Degree
Robert Figlin, MD FACP
First Name & Middle Initial & Last Name & Degree
Jun Gong, MD
First Name & Middle Initial & Last Name & Degree
Kevin Scher, MD MBA
First Name & Middle Initial & Last Name & Degree
David Hoffman, MD
First Name & Middle Initial & Last Name & Degree
Leland Green, MD
First Name & Middle Initial & Last Name & Degree
Kristopher Wentzel, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

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