Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-linePhase 2NCT01611558
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
A Phase 2 study testing Ipilimumab in people with Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line, run by Bristol-Myers Squibb at 17 sites in United States.
Trial summary
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 17 sitesUnited States
- Study dates
- 21 Aug 2012to 3 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Winship Cancer Institute.
Atlanta, Georgia, 30308
Georgia Regents University
Augusta, Georgia, 30912-3335
Dana Farber Cancer Institute.
Boston, Massachusetts, 02215
The Charlotte-Mecklenburg Hospital Authority
Charlotte, North Carolina, 28204
MetroHealth Medical Center
Cleveland, Ohio, 44109
Women'S Cancer Care
Covington, Louisiana, 70433
Duke University Medical Center
Durham, North Carolina, 27710
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois, 60521
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Yale University School Of Medicine
New Haven, Connecticut, 06520
Memorial Sloan Kettering Nassau
New York, New York, 10065
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
AdventHealth Cancer Institute
Orlando, Florida, 32804
Magee-Womens Hospital Of Upmc
Pittsburgh, Pennsylvania, 15213
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10461
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
About this study
Official title: 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
Read the detailed description
Condition: Ovarian Cancer, Second line, Third line, or Fourth line
- Being tested
- Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called Yervoy, BMS-734016
| Study group | Role | What they receive |
|---|---|---|
| Arm: Ipilimumab, 10 mg/kg | Experimental | 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. Receives: Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, first dose, to within 90 days of last dose in Induction Phase
Secondary outcomes (2)
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.
Measured: From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)
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.
Measured: From first dose to within 90 days of last study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study start21 Aug 2012
- Primary completion3 Nov 2014
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-lineStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611558
- Sponsor's protocol ID
- CA184-201
- Status last verified
- Jul 2020
- First submitted
- 25 May 2012
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
- ClinicalTrials.gov ID
- NCT01611558
- Acronym / sponsor ID
- CA184-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2012 (actual)
- Primary completion
- 3 Nov 2014 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Posted 19 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm: Ipilimumab, 10 mg/kg | Experimental | Biological: IpilimumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabAlso: Yervoy, BMS-734016 | Biological | Arm: Ipilimumab, 10 mg/kg |
Primary outcome
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.
2 secondary outcomes
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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab in people with Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line, run by Bristol-Myers Squibb at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.