Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Conditions
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
Interventions
BIOLOGICALIpilimumab
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher | 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
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response Rate (BORR) | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
40 participants enrolled and treated
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Induction Phase | Adverse event unrelated to study drug | 3 |
| Induction Phase | Death | 1 |
| Induction Phase | Disease progression | 18 |
| Induction Phase | Heart arrest,urosepsis,respiratory fail | 1 |
| Induction Phase | Study drug toxicity | 15 |
| Maintenance Phase | Elevated Uric acid | 1 |
| Maintenance Phase | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ipilimumab,10 mg/kg |
|---|---|
| Age, Continuous | 61.5 Years |
| Age, Customized 65 years and older | 12 Participants |
| Age, Customized Younger than 65 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 35 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 35 / 40 |
| other Total, other adverse events | 40 / 40 |
| serious Total, serious adverse events | 26 / 40 |
Outcome results
Primary
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
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.
Time frame: Day 1, first dose, to within 90 days of last dose in Induction Phase
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ipilimumab, 10 mg/kg | Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher | 20 Participants |
Secondary
Best Overall Response Rate (BORR)
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.
Time frame: From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)
Population: All participants who received study drug. n=number of evaluable participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ipilimumab, 10 mg/kg | Best Overall Response Rate (BORR) | 15.0 Percentage of participants |
Secondary
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
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.
Time frame: From first dose to within 90 days of last study dose
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab, 10 mg/kg | 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 | Deaths | 35 Participants |
| Ipilimumab, 10 mg/kg | 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 | SAEs(induction phase) | 26 Participants |
| Ipilimumab, 10 mg/kg | 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 | Drug-related SAEs | 16 Participants |
| Ipilimumab, 10 mg/kg | 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 | Drug-related AEs | 38 Participants |
| Ipilimumab, 10 mg/kg | 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 | AEs leading to discontinuation | 16 Participants |