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

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

Study Overview

• Status: Completed
• Conditions: Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
• Intervention / Treatment: Biological: Ipilimumab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Florida
    • Orlando, Florida, United States, 32804
      • AdventHealth Cancer Institute
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Winship Cancer Institute.
    • Augusta, Georgia, United States, 30912-3335
      • Georgia Regents University
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Dr. Sudarshan K. Sharma, Ltd.
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Melvin and Bren Simon Cancer Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Women'S Cancer Care
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute.
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Nassau
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • The Charlotte-Mecklenburg Hospital Authority
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Peggy and Charles Stephenson Cancer Center
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute, LLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: BMS-734016; Yervoy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From first dose to within 90 days of last study dose

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2012
• Primary Completion (ACTUAL): November 3, 2014
• Study Completion (ACTUAL): July 3, 2019

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Hypersensitivity; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasms, Second Primary; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: CA184-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No