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

NCT01611558 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CA184-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1, first dose, to within 90 days of last dose in Induction Phase

Secondary Outcomes (2)

• Best Overall Response Rate (BORR)

  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

  From first dose to within 90 days of last study dose

Study Arms (1)

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.

Biological: Ipilimumab

Interventions

Ipilimumab BIOLOGICAL

Also known as: Yervoy, BMS-734016

Arm: Ipilimumab, 10 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (17)

Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

Location

AdventHealth Cancer Institute

Orlando, Florida, 32804, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute.

Atlanta, Georgia, 30308, United States

Location

Georgia Regents University

Augusta, Georgia, 30912-3335, United States

Location

Dr. Sudarshan K. Sharma, Ltd.

Hinsdale, Illinois, 60521, United States

Location

Indiana University Health Melvin And Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Women'S Cancer Care

Covington, Louisiana, 70433, United States

Location

Dana Farber Cancer Institute.

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Nassau

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

The Charlotte-Mecklenburg Hospital Authority

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

Magee-Womens Hospital Of Upmc

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 5, 2012
• Study Start: August 21, 2012
• Primary Completion: November 3, 2014
• Study Completion: July 3, 2019
• Last Updated: July 13, 2020
• Results First Posted: April 19, 2016

Record last verified: 2020-07

Locations

US (17)