Trial Outcomes & Findings for Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer (NCT NCT01611558)
NCT ID: NCT01611558
Last Updated: 2020-07-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Day 1, first dose, to within 90 days of last dose in Induction Phase
Results posted on
2020-07-13
Participant Flow
40 participants enrolled and treated
Participant milestones
| Measure |
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.
|
|---|---|
|
Induction Phase
STARTED
|
40
|
|
Induction Phase
COMPLETED
|
2
|
|
Induction Phase
NOT COMPLETED
|
38
|
|
Maintenance Phase
STARTED
|
2
|
|
Maintenance Phase
COMPLETED
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Induction Phase
Study drug toxicity
|
15
|
|
Induction Phase
Disease progression
|
18
|
|
Induction Phase
Heart arrest,urosepsis,respiratory fail
|
1
|
|
Induction Phase
Adverse event unrelated to study drug
|
3
|
|
Induction Phase
Death
|
1
|
|
Maintenance Phase
Withdrawal by Subject
|
1
|
|
Maintenance Phase
Elevated Uric acid
|
1
|
Baseline Characteristics
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Ipilimumab,10 mg/kg
n=40 Participants
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.
|
|---|---|
|
Age, Continuous
|
61.5 Years
n=5 Participants
|
|
Age, Customized
Younger than 65 years
|
28 Participants
n=5 Participants
|
|
Age, Customized
65 years and older
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, first dose, to within 90 days of last dose in Induction PhasePopulation: All participants who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg
n=40 Participants
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.
|
|---|---|
|
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
|
20 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg
n=40 Participants
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.
|
|---|---|
|
Best Overall Response Rate (BORR)
|
15.0 Percentage of participants
Interval 5.7 to 29.8
|
SECONDARY outcome
Timeframe: From first dose to within 90 days of last study dosePopulation: All participants who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg
n=40 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
10 mg/kg Ipilimumab
Serious events: 26 serious events
Other events: 40 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
10 mg/kg Ipilimumab
n=40 participants at risk
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Endocrine disorders
Adrenal insufficiency
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Endocrine disorders
Hyperparathyroidism
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Endocrine disorders
Hypophysitis
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Colitis
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
General disorders
Generalised oedema
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
General disorders
Pyrexia
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Infections and infestations
Influenza
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Infections and infestations
Liver abscess
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Infections and infestations
Urosepsis
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Infections and infestations
Viral infection
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
5.0%
2/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Nervous system disorders
Cerebrovascular accident
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Nervous system disorders
Depressed level of consciousness
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Nervous system disorders
Transient ischaemic attack
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Psychiatric disorders
Psychotic disorder
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
2/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Vascular disorders
Venous thrombosis limb
|
2.5%
1/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
Other adverse events
| Measure |
10 mg/kg Ipilimumab
n=40 participants at risk
|
|---|---|
|
Cardiac disorders
Tachycardia
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Endocrine disorders
Adrenal insufficiency
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Endocrine disorders
Hypophysitis
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Endocrine disorders
Hypothyroidism
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
32.5%
13/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Constipation
|
27.5%
11/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
65.0%
26/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Nausea
|
40.0%
16/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
9/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
General disorders
Chills
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
General disorders
Fatigue
|
47.5%
19/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
General disorders
Pain
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
General disorders
Pyrexia
|
25.0%
10/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Infections and infestations
Bronchitis
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Infections and infestations
Urinary tract infection
|
22.5%
9/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
5/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
6/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Investigations
Blood creatinine increased
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
8/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
27.5%
11/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.5%
7/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
5/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Nervous system disorders
Headache
|
27.5%
11/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Nervous system disorders
Neuropathy peripheral
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Psychiatric disorders
Anxiety
|
12.5%
5/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Psychiatric disorders
Insomnia
|
12.5%
5/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.5%
7/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.5%
7/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
5/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.5%
3/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
52.5%
21/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.5%
17/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
|
Vascular disorders
Hypotension
|
12.5%
5/40 • On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER