Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009486

Trial Description

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Title

A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to examine the safety and effectiveness (how well the drug
works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients
with metastatic castration resistant prostate cancer.

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Brief Summary in Scientific Language

Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

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Organizational Data

  •   DRKS00009486
  •   2015/10/23
  •   2014/10/29
  •   no
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Secondary IDs

  •   2014-002987-34 
  •   NCT02279862  (ClinicalTrials.gov)
  •   CA184-437  (Bristol-Myers Squibb)
  •   2014-002987-34 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Ipilimumab
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
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  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Radiologic Progression Free Survival; time frame: Approximately up to 24 months; Radiographic PFS (rPFS) is defined as the time from randomization to the earliest date on which either of the following events was documented: Radiographic progression (per PCWG2 for bone lesions and modified RECIST 1.1 for non-bone lesions) or death. All radiological progression will be based on investigator assessments.

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Secondary Outcome

- Rate of severe immune-related adverse events (irAEs); time frame: Up to 90 days after last dose of Ipilimumab
- Overall Survival (OS); time frame: Approximately up to 48 months
- Prostate specific antigen progression-free survival (PSA PFS); time frame: Approximately up to 36 months
- Prostate specific antigen response rate; time frame: Approximately up to 48 months
- Time to pain progression; time frame: Approximately up to 48 months

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Countries of Recruitment

  •   Australia
  •   Chile
  •   France
  •   Germany
  •   Italy
  •   Mexico
  •   Netherlands
  •   Spain
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/12/31
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Prostate cancer with metastases

- Prostate cancer should be castration resistant

- Progression during hormonal therapy

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Exclusion Criteria

- Visceral metastases (eg liver, lung or brain metastases)

- Prior treatment with any immunotherapy for prostate cancer

- Prior or ongoing cytotoxic therapy for prostate cancer

- Autoimmune disease

- Inadequate hematologic, renal, or hepatic function

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Addresses

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    • Bristol-Myers Squibb
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    •   [---]*
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    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    •   [---]*
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  • start of 1:1-Block address public-contact
    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.