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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01611558
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : April 19, 2016
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment

Condition or disease Intervention/treatment Phase
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line Biological: Ipilimumab Phase 2

Detailed Description:
Condition: Ovarian Cancer, Second line, Third line, or Fourth line

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Actual Study Start Date : August 21, 2012
Actual Primary Completion Date : November 3, 2014
Actual Study Completion Date : July 3, 2019


Arm Intervention/treatment
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.
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611558


Locations
Show Show 17 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01611558    
Other Study ID Numbers: CA184-201
First Posted: June 5, 2012    Key Record Dates
Results First Posted: April 19, 2016
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Second Primary
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action