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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01611558
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : April 19, 2016
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Intervention Biological: Ipilimumab
Enrollment 49
Recruitment Details  
Pre-assignment Details A total of 49 participants were enrolled, and 40 received study drug. Of those 9 who did not receive treatment, 7 no longer met study criteria, 1 withdrew consent, and 1 was excluded due to poor compliance with study procedures.
Arm/Group Title Ipilimumab, 10 mg/kg
Hide Arm/Group Description 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.
Period Title: Induction Phase
Started 40
Completed 2
Not Completed 38
Reason Not Completed
Study drug toxicity             17
Disease progression             14
Not reported             5
Adverse event unrelated to study drug             1
Death             1
Period Title: Maintenance Phase
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Study drug toxicity             1
Arm/Group Title Ipilimumab,10 mg/kg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
61.5
(42.0 to 74.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
Younger than 65 years 28
65 years and older 12
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
40
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
4
  10.0%
Not Hispanic or Latino
36
  90.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
White 35
Black or African American 2
Asian 2
Other 1
1.Primary Outcome
Title Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Ipilimumab, 10 mg/kg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
20
2.Secondary Outcome
Title Best Overall Response Rate (BORR)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug. n=number of evaluable participants
Arm/Group Title Ipilimumab,10 mg/kg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
By RECIST (n=39)
10.3
(2.9 to 34.2)
By Rustin CA125 level criteria (n=18)
11.1
(1.4 to 34.7)
3.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Ipilimumab,10 mg/kg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Deaths 2
SAEs 26
Drug-related SAEs 18
Drug-related AEs 38
AEs leading to discontinuation 17
Drug-related AEs leading to discontinuation 14
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ipilimumab, 10 mg/kg
Hide Arm/Group Description 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.
All-Cause Mortality
Ipilimumab, 10 mg/kg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ipilimumab, 10 mg/kg
Affected / at Risk (%)
Total   26/40 (65.00%) 
Cardiac disorders   
Cardiac arrest  1  1/40 (2.50%) 
Endocrine disorders   
Adrenal insufficiency  1  3/40 (7.50%) 
Hypophysitis  1  1/40 (2.50%) 
Gastrointestinal disorders   
Colitis  1  2/40 (5.00%) 
Nausea  1  1/40 (2.50%) 
Pancreatitis  1  1/40 (2.50%) 
Abdominal pain  1  1/40 (2.50%) 
Intestinal obstruction  1  1/40 (2.50%) 
Intestinal perforation  1  1/40 (2.50%) 
Small intestinal obstruction  1  4/40 (10.00%) 
Diarrhoea  1  4/40 (10.00%) 
Gastrointestinal haemorrhage  1  1/40 (2.50%) 
Haematochezia  1  1/40 (2.50%) 
Constipation  1  1/40 (2.50%) 
General disorders   
Fatigue  1  1/40 (2.50%) 
Pyrexia  1  1/40 (2.50%) 
Generalised oedema  1  1/40 (2.50%) 
Infections and infestations   
Influenza  1  1/40 (2.50%) 
Viral infection  1  1/40 (2.50%) 
Urosepsis  1  1/40 (2.50%) 
Liver abscess  1  1/40 (2.50%) 
Injury, poisoning and procedural complications   
Incisional hernia, obstructive  1  2/40 (5.00%) 
Investigations   
Lipase increased  1  1/40 (2.50%) 
Alanine aminotransferase increased  1  1/40 (2.50%) 
Blood bilirubin increased  1  1/40 (2.50%) 
Aspartate aminotransferase increased  1  1/40 (2.50%) 
Metabolism and nutrition disorders   
Hyponatraemia  1  2/40 (5.00%) 
Hypercalcaemia  1  1/40 (2.50%) 
Dehydration  1  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/40 (2.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Ovarian cancer  1  1/40 (2.50%) 
Nervous system disorders   
Depressed level of consciousness  1  1/40 (2.50%) 
Cerebrovascular accident  1  1/40 (2.50%) 
Transient ischaemic attack  1  1/40 (2.50%) 
Tremor  1  1/40 (2.50%) 
Psychiatric disorders   
Psychotic disorder  1  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/40 (2.50%) 
Hypoxia  1  1/40 (2.50%) 
Pneumonitis  1  4/40 (10.00%) 
Respiratory failure  1  1/40 (2.50%) 
Pleural effusion  1  2/40 (5.00%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/40 (2.50%) 
Vascular disorders   
Venous thrombosis limb  1  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ipilimumab, 10 mg/kg
Affected / at Risk (%)
Total   40/40 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  3/40 (7.50%) 
Cardiac disorders   
Tachycardia  1  4/40 (10.00%) 
Endocrine disorders   
Adrenal insufficiency  1  3/40 (7.50%) 
Hypophysitis  1  4/40 (10.00%) 
Hypothyroidism  1  5/40 (12.50%) 
Gastrointestinal disorders   
Nausea  1  17/40 (42.50%) 
Dyspepsia  1  2/40 (5.00%) 
Stomatitis  1  2/40 (5.00%) 
Vomiting  1  9/40 (22.50%) 
Abdominal pain  1  13/40 (32.50%) 
Diarrhoea  1  26/40 (65.00%) 
Abdominal distension  1  2/40 (5.00%) 
Constipation  1  11/40 (27.50%) 
General disorders   
Chills  1  4/40 (10.00%) 
Fatigue  1  21/40 (52.50%) 
Pyrexia  1  11/40 (27.50%) 
Asthenia  1  2/40 (5.00%) 
Oedema peripheral  1  2/40 (5.00%) 
Pain  1  3/40 (7.50%) 
Immune system disorders   
Hypersensitivity  1  2/40 (5.00%) 
Infections and infestations   
Urinary tract infection  1  9/40 (22.50%) 
Bronchitis  1  3/40 (7.50%) 
Upper respiratory tract infection  1  2/40 (5.00%) 
Investigations   
Alanine aminotransferase increased  1  5/40 (12.50%) 
Blood alkaline phosphatase increased  1  4/40 (10.00%) 
Blood creatinine increased  1  2/40 (5.00%) 
Amylase increased  1  2/40 (5.00%) 
Aspartate aminotransferase increased  1  6/40 (15.00%) 
Metabolism and nutrition disorders   
Hyponatraemia  1  3/40 (7.50%) 
Hypercalcaemia  1  2/40 (5.00%) 
Hypoalbuminaemia  1  2/40 (5.00%) 
Hyperglycaemia  1  4/40 (10.00%) 
Hypomagnesaemia  1  5/40 (12.50%) 
Hyperkalaemia  1  2/40 (5.00%) 
Hypokalaemia  1  8/40 (20.00%) 
Dehydration  1  11/40 (27.50%) 
Decreased appetite  1  8/40 (20.00%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  2/40 (5.00%) 
Arthralgia  1  2/40 (5.00%) 
Myalgia  1  2/40 (5.00%) 
Nervous system disorders   
Neuropathy peripheral  1  4/40 (10.00%) 
Dizziness  1  4/40 (10.00%) 
Headache  1  12/40 (30.00%) 
Psychiatric disorders   
Confusional state  1  2/40 (5.00%) 
Anxiety  1  2/40 (5.00%) 
Insomnia  1  5/40 (12.50%) 
Depression  1  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1  2/40 (5.00%) 
Oropharyngeal pain  1  5/40 (12.50%) 
Dyspnoea  1  8/40 (20.00%) 
Dyspnoea exertional  1  2/40 (5.00%) 
Pneumonitis  1  2/40 (5.00%) 
Cough  1  7/40 (17.50%) 
Nasal congestion  1  2/40 (5.00%) 
Pleural effusion  1  2/40 (5.00%) 
Skin and subcutaneous tissue disorders   
Erythema  1  3/40 (7.50%) 
Urticaria  1  2/40 (5.00%) 
Rash  1  17/40 (42.50%) 
Rash pruritic  1  2/40 (5.00%) 
Rash maculo-papular  1  2/40 (5.00%) 
Dry skin  1  3/40 (7.50%) 
Pruritus  1  21/40 (52.50%) 
Vascular disorders   
Hypotension  1  4/40 (10.00%) 
Hypertension  1  2/40 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01611558     History of Changes
Other Study ID Numbers: CA184-201
First Submitted: May 25, 2012
First Posted: June 5, 2012
Results First Submitted: March 7, 2016
Results First Posted: April 19, 2016
Last Update Posted: August 13, 2019