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Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01611558
First received: May 25, 2012
Last updated: March 21, 2016
Last verified: March 2016

May 25, 2012
March 21, 2016
August 2012
November 2014   (final data collection date for primary outcome measure)
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher [ Time Frame: Day 1, first dose, to within 90 days of last dose in Induction Phase ] [ Designated as safety issue: Yes ]
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.
The incidence of drug-related adverse events of grade 3 or higher during the induction period of Ipilimumab [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01611558 on ClinicalTrials.gov Archive Site
  • Best Overall Response Rate (BORR) [ Time Frame: From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years) ] [ Designated as safety issue: No ]
    BORR is defined as the percentage of participants who received treatment and, at any time during the study, had a best response of complete response or partial response, as confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria for patients with cancer antigen 125 (CA125) levels elevated to twice the upper limit of normal at baseline, divided by the total number of evaluable participants in the arm.
  • Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation [ Time Frame: From first dose to within 90 days of last study dose ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
BORR defined as the proportion of all treated subjects whose best response at any time during the study to date following initiation of therapy is confirmed Complete Response (CR) or confirmed Partial Response (PR) [ Time Frame: Weeks, 6, 12, 18, and 24 during induction phase, and every 12 weeks during maintenance phase until Immune-Related Progressive Disease (irPD) ] [ Designated as safety issue: No ]
Best overall response rate (BORR) assessed according to immune-related response criteria (irRC), as well as separately by Modified World Health Organization criteria (mWHO) criteria, and by CA125 Rustin criteria
Not Provided
Not Provided
 
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
Condition: Ovarian Cancer, Second line, Third line, or Fourth line
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
Experimental: Arm: Ipilimumab, 10 mg/kg
Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
Intervention: Biological: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
49
July 2019
November 2014   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria

  • Ovarian cancer that is not refractory or resistant to platinum-based therapy (refactory=progression while receiving any previous platinum regimen; resistant=progression within 6 months of any previous platinum regimen)
  • Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian cancer
  • An Eastern Cooperative Oncology Group performance status ≤1
  • Up to 4 prior lines of therapy for ovarian cancer
  • Two groups are eligible:

Group 1. Women who have not met the criteria for progressive disease following their most recent chemotherapeutic regimen were required to have:

  • Demonstrated partial response or stable disease following the most recent chemotherapy regimen
  • Evaluable or measurable disease, detected by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women with disease progression while receiving or following the last dose of the most recent chemotherapeutic regimen were required to have:
  • Measurable disease on a CT or MRI scan performed within 28 days of first dose of ipilimumab.
  • Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer at least 4 weeks prior to the first administration of ipilimumab.

Key Exclusion Criteria

  • Histologic diagnosis of borderline, low malignant potential epithelial carcinoma
  • For Group 1, women with complete response on the most recent ovarian carcinomatherapy
  • Presence of known brain metastases
  • Second malignancy active within the past 5 years, with the exception of locally curable cancers that have no need for subsequent therapy
  • Documented history of severe autoimmune or immune-mediated symptomatic disease requiring prolonged systemic immunosuppressive treatment
  • History of motor neuropathy considered to be of autoimmune origin or the of grade 2 or higher peripheral neuropathy
  • History of toxic epidermal necrolysis
  • Prior therapies with immunosuppressive agents within the last 2 years (excluding low-dose corticosteroids) and prior therapies with cytotoxic drugs within 4 weeks
  • Chronic use of systemic immunosuppressive drugs, ongoing use of immunotherapy or biologic therapy for the treatment of cancer, or prior use of ipilimumab or any immune-stimulating agent.
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01611558
CA184-201
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP