Clinical trial NCT01611558: Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Official title: A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
timeFrame: Day 1, first dose, to within 90 days of last dose in Induction Phase
Secondary outcomes:
measure: Best Overall Response Rate (BORR)
timeFrame: From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)
measure: 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
timeFrame: From first dose to within 90 days of last study dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth Cancer Institute
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute.
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Hinsdale
country: United States
facility: Dr. Sudarshan K. Sharma, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Melvin And Bren Simon Cancer Center
state: Indiana
city: Covington
country: United States
facility: Women'S Cancer Care
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute.
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Charlotte
country: United States
facility: The Charlotte-Mecklenburg Hospital Authority
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital Of Upmc
state: Pennsylvania
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: