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A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer (Tamarack)

Primary Purpose

Castration-Resistant Prostatic Cancer, Androgen-Independent Prostatic Cancer, Androgen-Insensitive Prostatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
vobramitamab duocarmazine 2.0 mg (Arm A)
vobramitamab duocarmazine 2.7 mg (Arm B)
Sponsored by
MacroGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Castration-Resistant Prostatic Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
  • Participants must have ≥ 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
  • Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
  • Received 1 prior ARAT for metastatic prostate cancer (mPC) with lack of progression for at least 12 months
  • Received 1 prior taxane-containing regimen for mPC.
  • May have received up to 1 prior cabazitaxel regiment for mPC.
  • Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
  • Acceptable physical condition and laboratory values.

Exclusion Criteria:

  • Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
  • Prior chemotherapy other than docetaxel or cabazitaxel. Prior immunotherapy and radiopharmaceutical therapy is allowed.
  • Known history of documented BRCA or ATM mutation (germline or somatic). Participants with known BRCA or ATM mutation who had disease progression or unacceptable toxicity on a PARP inhibitor are eligible.
  • Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
  • Untreated, symptomatic central nervous system (CNS) metastasis.
  • Prior treatment with any B7-H3 targeted agent for cancer,
  • Contradictions to the use of corticosteroid treatment
  • Prior stem cell, tissue, or solid organ transplant.

Sites / Locations

  • Compassionate Cancer Care Medical GroupRecruiting
  • University of California Los Angeles (UCLA) Community Cancer CareRecruiting
  • The University of Florida Health System - UF Health Urology - JacksonvilleRecruiting
  • Mid Florida Hematology and Oncology CenterRecruiting
  • Pontchartrain Cancer CenterRecruiting
  • The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruiting
  • Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research CenterRecruiting
  • Masonic Cancer Center, University of MinnesotaRecruiting
  • Gabrail Cancer CenterRecruiting
  • VA Portland Health Care ServicesRecruiting
  • Carolina Urologic Research CenterRecruiting
  • University of Virginia Comprehensive Cancer CenterRecruiting
  • Virginia Cancer SpecalistsRecruiting
  • Fred Hutchinson Cancer CenterRecruiting
  • Ramsay Health Care - Westmead Private HospitalRecruiting
  • The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)Recruiting
  • Cabrini Health- MalvernRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • (Grand Hopital de Charleroi) GHDCRecruiting
  • Centre Hospitalier de Ardenne - Libramont - Clinique du SeinRecruiting
  • Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)Recruiting
  • Algemeen Ziekenhuis Maria MiddelaresRecruiting
  • Centre Antoine-LacassagneRecruiting
  • Institut de Cancerologie Strasbourg Europe (ICANS)Recruiting
  • Institut BergoniéRecruiting
  • Institut régional du Cancer de Montpellier - ICM Val d'AurelleRecruiting
  • Hôpital d'Instruction des Armées BéginRecruiting
  • Hopital FochRecruiting
  • Centre Hospitalier Privé Saint-GrégoireRecruiting
  • Clinique Victor HugoRecruiting
  • Gustave RoussyRecruiting
  • CHRU BrestRecruiting
  • Institut Mutualiste MontsourisRecruiting
  • AOU San Luigi Gonzaga Oncology DepartmentRecruiting
  • Ospedale dell'AngeloRecruiting
  • Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of FlorenceRecruiting
  • Istituto Oncologico VenetoRecruiting
  • Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. ChiaraRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • National Cancer CenterRecruiting
  • Chonnam National University HospitalRecruiting
  • Seoul National University HopitalRecruiting
  • Yonsei University Health System, Severance HospitalRecruiting
  • Samsung Meical CemterRecruiting
  • Ewha Womans University Mokdong HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Szpital im. Fryderyka ChopinaRecruiting
  • Magodent Szpital ElblaskaRecruiting
  • Medical Concierge Centrum MedyczneRecruiting
  • Grochowski HospitalRecruiting
  • Przychodnia Lekarska "KOMED"Recruiting
  • Szpital Wojewodzki im. Mikolaja KopernikaRecruiting
  • Hospital Universitari Parc TaulíRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Hospital Del MarRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital de la Santa Creu I Sant PauRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • The Royal Marsden NHS TrustRecruiting
  • Oxford University Hospitals NHS- Churchill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MGC018 2.0 mg (Arm A)

MGC018 2.7 mg (Arm B)

Arm Description

MGC018 2.0 mg/kg every 4 weeks

MGC018 2.7 mg/kg every 4 weeks

Outcomes

Primary Outcome Measures

Radiographic progression free survival (rPFS) as determined by the investigator
The rPFS is defined as the time from the date of randomization to the date of first documented progressive disease (PD) per Prostate Cancer Working Group 3 (PCWG3) or death from any cause, whichever occurs first. Three arms will be compared: Arm A, Arm B, and control.

Secondary Outcome Measures

Objective response rate (ORR) by PCWG3 criteria using investigator review
The number of participants experiencing a complete response (CR) or partial response (PR) to treatment.
Duration of response (DoR) per PCWG3 criteria using investigator review
The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
Prostate-specific Cancer Antigen (PSA) response rate per PCWG3 criteria
PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
Time to PSA progression per PCWG3 criteria
In participants with a decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks.
Duration of PSA response per PCWG3 criteria
Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.
PSA percent change over time
Best PSA percent change
Time to first symptomatic skeletal event (SSE)
An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.
Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation.
Number of participants who develop anti-drug antibodies
maximum concentration or concentration at the end of infusion (Cmax)
The highest measured concentration of vobramitamab duocarmazine in the bloodstream.
area under the concentration time curve (AUC)
AUC is the total amount of vobramitamab duocarmazine in bloodstream after drug administration
Trough drug concentration (Ctrough or Cmin)
Trough concentration is the concentration measured before a subsequent dose of vobramitamab duocarmazine
Clearance (CL)
Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time
Volume of distribution (Vz)
The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream.
Terminal half-life
Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%

Full Information

First Posted
September 19, 2022
Last Updated
October 20, 2023
Sponsor
MacroGenics
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1. Study Identification

Unique Protocol Identification Number
NCT05551117
Brief Title
A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer
Acronym
Tamarack
Official Title
A Phase 2, Randomized, Open-label, Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics

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
Study CP-MGC018-03 is a randomized, open-label, Phase 2 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior taxane-containing regimen, but no other chemotherapy agents. The study will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg every 4 weeks [Q4W] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26 cycles, approximately 2 years, until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor. An analysis of radiographic progression-free survival (rPFS) will occur after 100 participants have been on-study for at least 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-Resistant Prostatic Cancer, Androgen-Independent Prostatic Cancer, Androgen-Insensitive Prostatic Cancer, Androgen-Resistant Prostatic Cancer, Hormone Refractory Prostatic Cancer

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
MGC018 2.0 mg (Arm A)
Arm Type
Experimental
Arm Description
MGC018 2.0 mg/kg every 4 weeks
Arm Title
MGC018 2.7 mg (Arm B)
Arm Type
Experimental
Arm Description
MGC018 2.7 mg/kg every 4 weeks
Intervention Type
Biological
Intervention Name(s)
vobramitamab duocarmazine 2.0 mg (Arm A)
Other Intervention Name(s)
MGC018
Intervention Description
2.0 mg/kg intravenous (IV) every 4 weeks
Intervention Type
Biological
Intervention Name(s)
vobramitamab duocarmazine 2.7 mg (Arm B)
Other Intervention Name(s)
MGC018
Intervention Description
2.7 mg.kg IV every 4 weeks
Primary Outcome Measure Information:
Title
Radiographic progression free survival (rPFS) as determined by the investigator
Description
The rPFS is defined as the time from the date of randomization to the date of first documented progressive disease (PD) per Prostate Cancer Working Group 3 (PCWG3) or death from any cause, whichever occurs first. Three arms will be compared: Arm A, Arm B, and control.
Time Frame
Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) by PCWG3 criteria using investigator review
Description
The number of participants experiencing a complete response (CR) or partial response (PR) to treatment.
Time Frame
Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
Title
Duration of response (DoR) per PCWG3 criteria using investigator review
Description
The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
Time Frame
Every 8 weeks throughout study participation, up to 2 years
Title
Prostate-specific Cancer Antigen (PSA) response rate per PCWG3 criteria
Description
PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
Time Frame
Every 4 weeks throughout study participation, up to 2 years
Title
Time to PSA progression per PCWG3 criteria
Description
In participants with a decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks.
Time Frame
Every 4 weeks throughout study participation, up to 2 years
Title
Duration of PSA response per PCWG3 criteria
Description
Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.
Time Frame
Every 4 weeks throughout study participation, up to 2 years
Title
PSA percent change over time
Time Frame
Every 4 weeks throughout study participation, up to 2 years
Title
Best PSA percent change
Time Frame
Every 4 weeks throughout study participation, up to 2 years
Title
Time to first symptomatic skeletal event (SSE)
Description
An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.
Time Frame
Every 4 weeks throughout the study, up to 2 years
Title
Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation.
Time Frame
Throughout the study, up to 2 years
Title
Number of participants who develop anti-drug antibodies
Time Frame
Throughout the study, up to 2 years
Title
maximum concentration or concentration at the end of infusion (Cmax)
Description
The highest measured concentration of vobramitamab duocarmazine in the bloodstream.
Time Frame
Cycle 1, Day 1: Predose, end of infusion (EOI [1 hour]), 2-4 hours after EOI, 6-8 hours after EOI, and Cycle 1 Day 15. Pre-infusion and EOI on Cycle 2 Days 1, Cycle 2 Day 15; Pre-infusion and EOI on Day 1 of Cycles 3, 4, 5, 6, 9 and 12 (28-day cycle)
Title
area under the concentration time curve (AUC)
Description
AUC is the total amount of vobramitamab duocarmazine in bloodstream after drug administration
Time Frame
Cycle 1, Day 1: Predose, end of infusion (EOI [1 hour]), 2-4 hours after EOI, 6-8 hours after EOI, and Cycle 1 Day 15. Pre-infusion and EOI on Cycle 2 Days 1, Cycle 2 Day 15; Pre-infusion and EOI on Day 1 of Cycles 3, 4, 5, 6, 9 and 12 (28-day cycle)
Title
Trough drug concentration (Ctrough or Cmin)
Description
Trough concentration is the concentration measured before a subsequent dose of vobramitamab duocarmazine
Time Frame
Cycle 1, Day 1: Predose, end of infusion (EOI [1 hour]), 2-4 hours after EOI, 6-8 hours after EOI, and Cycle 1 Day 15. Pre-infusion and EOI on Cycle 2 Days 1, Cycle 2 Day 15; Pre-infusion and EOI on Day 1 of Cycles 3, 4, 5, 6, 9 and 12 (28-day cycle)
Title
Clearance (CL)
Description
Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time
Time Frame
Cycle 1, Day 1: Predose, end of infusion (EOI [1 hour]), 2-4 hours after EOI, 6-8 hours after EOI, and Cycle 1 Day 15. Pre-infusion and EOI on Cycle 2 Days 1, Cycle 2 Day 15; Pre-infusion and EOI on Day 1 of Cycles 3, 4, 5, 6, 9 and 12 (28-day cycle)
Title
Volume of distribution (Vz)
Description
The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream.
Time Frame
Cycle 1, Day 1: Predose, end of infusion (EOI [1 hour]), 2-4 hours after EOI, 6-8 hours after EOI, and Cycle 1 Day 15. Pre-infusion and EOI on Cycle 2 Days 1, Cycle 2 Day 15; Pre-infusion and EOI on Day 1 of Cycles 3, 4, 5, 6, 9 and 12 (28-day cycle)
Title
Terminal half-life
Description
Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%
Time Frame
Cycle 1, Day 1: Predose, end of infusion (EOI [1 hour]), 2-4 hours after EOI, 6-8 hours after EOI, and Cycle 1 Day 15. Pre-infusion and EOI on Cycle 2 Days 1, Cycle 2 Day 15; Pre-infusion and EOI on Day 1 of Cycles 3, 4, 5, 6, 9 and 12 (28-day cycle)

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features. Participants must have ≥ 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment. Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of <60 days used as bridging to lutetium-177 is permitted. Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs Acceptable physical condition and laboratory values. Exclusion Criteria: Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures. Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of <60 days used as bridging for lutetium-177 is permitted. Received >3 total prior therapies for mCRPC Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated. Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible. Untreated, symptomatic central nervous system (CNS) metastasis. Prior treatment with any B7-H3 targeted agent for cancer, Contradictions to the use of corticosteroid treatment Prior stem cell, tissue, or solid organ transplant. Use of products that have published anti-prostate cancer activity or are known to decrease PSA.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Global Trial Manager
Phone
301-251-5172
Email
info@macrogenics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Ward, M.D.
Organizational Affiliation
MacroGenics
Official's Role
Study Director
Facility Information:
Facility Name
Compassionate Cancer Care Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shama Hussain
First Name & Middle Initial & Last Name & Degree
Eric Lee, MD
Facility Name
University of California Los Angeles (UCLA) Community Cancer Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Hernandez
First Name & Middle Initial & Last Name & Degree
John Shen, MD
Facility Name
The University of Florida Health System - UF Health Urology - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guerline St Louis
First Name & Middle Initial & Last Name & Degree
Kethanda Balaji, MD
Facility Name
Mid Florida Hematology and Oncology Center
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiran Penta
First Name & Middle Initial & Last Name & Degree
Santosh Nair, MD
Facility Name
Pontchartrain Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Tergre
First Name & Middle Initial & Last Name & Degree
David Oubre, MD
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Agbanlog
First Name & Middle Initial & Last Name & Degree
Eugene Shenderov, MD
Facility Name
Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Mladenovski
First Name & Middle Initial & Last Name & Degree
Elisabeth Heath, MD
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleena Rehman
First Name & Middle Initial & Last Name & Degree
Emmanuel Antonarakis, MD
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Roby
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail, MD
Facility Name
VA Portland Health Care Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Sitch
First Name & Middle Initial & Last Name & Degree
Julie Graff, MD
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Valipour
First Name & Middle Initial & Last Name & Degree
Neal Shore, MD
Facility Name
University of Virginia Comprehensive Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jemima Tennant
First Name & Middle Initial & Last Name & Degree
Robert Driecer, MD
Facility Name
Virginia Cancer Specalists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice Alcaide
First Name & Middle Initial & Last Name & Degree
Alexander Spira
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Romani
First Name & Middle Initial & Last Name & Degree
Jessica Hawley, MD
Facility Name
Ramsay Health Care - Westmead Private Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikita Kherodiya
First Name & Middle Initial & Last Name & Degree
Howard Gurney, MD
Facility Name
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Suffolk
First Name & Middle Initial & Last Name & Degree
Aaron Hansen, MD
Facility Name
Cabrini Health- Malvern
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koby Scarff
First Name & Middle Initial & Last Name & Degree
David Pook
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Burke
First Name & Middle Initial & Last Name & Degree
Shahneen Sandhu, MD
Facility Name
Cliniques Universitaires Saint-Luc
City
Woluwe-Saint-Lambert
State/Province
Brussles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karoline Amann
First Name & Middle Initial & Last Name & Degree
Jean Pascal Machiels, MD
Facility Name
(Grand Hopital de Charleroi) GHDC
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy Van Der Perren
First Name & Middle Initial & Last Name & Degree
Vincent Verschaeve, MD
Facility Name
Centre Hospitalier de Ardenne - Libramont - Clinique du Sein
City
Libramont
State/Province
Luxembourg
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Celine
First Name & Middle Initial & Last Name & Degree
Frederic Forget, MD
Facility Name
Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)
City
Godinne
State/Province
Namur
ZIP/Postal Code
5300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Bellemans
First Name & Middle Initial & Last Name & Degree
Lionel D'Hondt, MD
Facility Name
Algemeen Ziekenhuis Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hollevoet
First Name & Middle Initial & Last Name & Degree
Christof Vulsteke, MD
Facility Name
Centre Antoine-Lacassagne
City
Nice Cedex 2
State/Province
AM
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahmim Feryel
First Name & Middle Initial & Last Name & Degree
Delphine Borchiellini, MD
Facility Name
Institut de Cancerologie Strasbourg Europe (ICANS)
City
Strasbourg
State/Province
Bas Rhin
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Anthony
First Name & Middle Initial & Last Name & Degree
Philippe Barthelemy, MD
Facility Name
Institut Bergonié
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Laillault
First Name & Middle Initial & Last Name & Degree
Guilhem Roubaud, MD
Facility Name
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Nauleau
First Name & Middle Initial & Last Name & Degree
Diego Tosi, MD
Facility Name
Hôpital d'Instruction des Armées Bégin
City
Saint-Mandé
State/Province
Ile De France
ZIP/Postal Code
94160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salima Bouktit
First Name & Middle Initial & Last Name & Degree
Carole Helissey, MD
Facility Name
Hopital Foch
City
Suresnes
State/Province
Ile De France
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Abraham
First Name & Middle Initial & Last Name & Degree
Raffaele Ratta, MD
Facility Name
Centre Hospitalier Privé Saint-Grégoire
City
Saint-Grégoire
State/Province
Ille Et Vilaine
ZIP/Postal Code
35760
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Hamery-Gruel
First Name & Middle Initial & Last Name & Degree
Xavier Artignan, MD
Facility Name
Clinique Victor Hugo
City
Le Mans
State/Province
Sarthe
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Foubert
First Name & Middle Initial & Last Name & Degree
Eric Voog, MD
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Kaila
First Name & Middle Initial & Last Name & Degree
Karim Fizazi, MD
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine Senant
First Name & Middle Initial & Last Name & Degree
Friederike Schlurmann, MD
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kossi Taffame
First Name & Middle Initial & Last Name & Degree
Mostefa Bennamoun, MD
Facility Name
AOU San Luigi Gonzaga Oncology Department
City
Orbassano
State/Province
TO
ZIP/Postal Code
10049
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Benzonelli
First Name & Middle Initial & Last Name & Degree
Consuelo Buttigliero, MD
Facility Name
Ospedale dell'Angelo
City
Mestre
State/Province
Venice
ZIP/Postal Code
30174
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Coccato
First Name & Middle Initial & Last Name & Degree
Donata Sartori, MD
Facility Name
Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Paolini
First Name & Middle Initial & Last Name & Degree
Lorenzo Livi, MD
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edoardo Vignaga
First Name & Middle Initial & Last Name & Degree
Umberto Basso, MD
Facility Name
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
City
Trento
ZIP/Postal Code
38122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Pontalti
First Name & Middle Initial & Last Name & Degree
Orazio Caffo, MD
Facility Name
Kyungpook National University Chilgok Hospital
City
Bugok
State/Province
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Nyung Lee
First Name & Middle Initial & Last Name & Degree
Tae Gyun Kwon, MD
Facility Name
National Cancer Center
City
Goyang
State/Province
Kyonggi
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somyung Yoo
First Name & Middle Initial & Last Name & Degree
Jae Young Joung, MD
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areum Kim
First Name & Middle Initial & Last Name & Degree
Taek Won Kang, MD
Facility Name
Seoul National University Hopital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeonghwa Lee
First Name & Middle Initial & Last Name & Degree
Cheol Kwak, MD
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areum Kwon
First Name & Middle Initial & Last Name & Degree
Sangjoon Shin, MD
Facility Name
Samsung Meical Cemter
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuna Im
First Name & Middle Initial & Last Name & Degree
Se Hoon Park, MD
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungmi Park
First Name & Middle Initial & Last Name & Degree
Choung Soo Kim, MD
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Kim
First Name & Middle Initial & Last Name & Degree
Jae-Lyun Lee, MD
Facility Name
Szpital im. Fryderyka Chopina
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Stemler
First Name & Middle Initial & Last Name & Degree
Cezary Szczylik, MD
Facility Name
Magodent Szpital Elblaska
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagmara Ziomek
First Name & Middle Initial & Last Name & Degree
Jakub Zolnierek, MD
Facility Name
Medical Concierge Centrum Medyczne
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-798
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artur Radziszewski
First Name & Middle Initial & Last Name & Degree
Piotr Radziszewski, MD
Facility Name
Grochowski Hospital
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-073
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beata Nasilowska
First Name & Middle Initial & Last Name & Degree
Iwona Skoneczna, MD
Facility Name
Przychodnia Lekarska "KOMED"
City
Konin
State/Province
Wlkp
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Witasik
First Name & Middle Initial & Last Name & Degree
Boguslawa Karaszewska, MD
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Porzych
First Name & Middle Initial & Last Name & Degree
Mariusz Kwiatkowski, MD
Facility Name
Hospital Universitari Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Garante
First Name & Middle Initial & Last Name & Degree
Enrique Gallardo, MD
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
State/Province
Seville
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Lopez Santamaria
First Name & Middle Initial & Last Name & Degree
Begona Perez-Valderama, MD
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Moreno
First Name & Middle Initial & Last Name & Degree
Alejo Rodriquez-Vida, MD
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Airan Alonso
First Name & Middle Initial & Last Name & Degree
Dra Begona Mellado, MD
Facility Name
Hospital de la Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ona Ramirez
First Name & Middle Initial & Last Name & Degree
Jose Pablo Maroto Rey, MD
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Romero Van Der Schoot
First Name & Middle Initial & Last Name & Degree
Sergio Vazquez Estevez, MD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Lucas
First Name & Middle Initial & Last Name & Degree
David Olmos-Hidalgo, MD
Facility Name
The Royal Marsden NHS Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann De Bono
First Name & Middle Initial & Last Name & Degree
Johann De Bono, MD
Facility Name
Oxford University Hospitals NHS- Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Tuthill
First Name & Middle Initial & Last Name & Degree
Mark Tuthill, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer

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