Trial Outcomes & Findings for Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma (NCT NCT01709162)
NCT ID: NCT01709162
Last Updated: 2015-11-30
Results Overview
Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
From randomization to death or last known alive date, assessed up to 15.6 months
Results posted on
2015-11-30
Participant Flow
A total of 31 participants were enrolled. Of the 23 who were randomized, 22 received treatment .
Participant milestones
| Measure |
Ipilimumab, 3 mg/kg
Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
|
Chemotherapy
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
5
|
|
Overall Study
Received Treatment
|
18
|
4
|
|
Overall Study
Still Receiving Treatment
|
0
|
0
|
|
Overall Study
COMPLETED
|
12
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Ipilimumab, 3 mg/kg
Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
|
Chemotherapy
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
|
|---|---|---|
|
Overall Study
Disease progression
|
3
|
3
|
|
Overall Study
Study drug toxicity
|
2
|
0
|
|
Overall Study
Administrative reason by sponsor
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Ipilimumab, 3 mg/kg
n=18 Participants
Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
|
Chemotherapy
n=5 Participants
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 4.32 • n=7 Participants
|
62.7 Years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Disease Stage at Study Entry
Stage III
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Disease Stage at Study Entry
Stage IV
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Objective Response to Prior Ipilimumab Treatment
Complete response/Partial response
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Objective Response to Prior Ipilimumab Treatment
Stable disease
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to death or last known alive date, assessed up to 15.6 monthsPopulation: All participants who were randomized
Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)
Outcome measures
| Measure |
Ipilimumab, 3 mg/kg
n=18 Participants
Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
|
Chemotherapy
n=5 Participants
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
|
|---|---|---|
|
Overall Survival
|
6.3 Months
Interval 3.2 to 15.6
|
3.1 Months
Interval 0.0 to 8.6
|
SECONDARY outcome
Timeframe: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive diseasePopulation: All participants who were randomized
DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive diseasePopulation: All participants who were randomized
BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 1 of treatment to 90 days after last dose (or to death date for death information)Population: 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. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Outcome measures
| Measure |
Ipilimumab, 3 mg/kg
n=18 Participants
Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
|
Chemotherapy
n=4 Participants
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
|
|---|---|---|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
Deaths
|
5 Participants
|
1 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
Deaths within 90 days of last dose
|
1 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
AEs leading to discontinuation
|
2 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
SAEs
|
7 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
irAEs
|
10 Participants
|
1 Participants
|
Adverse Events
Ipilimumab, 3 mg/kg
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Chemotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipilimumab, 3 mg/kg
n=18 participants at risk
Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
|
Chemotherapy
n=4 participants at risk
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
5.6%
1/18
|
0.00%
0/4
|
|
Vascular disorders
Orthostatic hypotension
|
5.6%
1/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Pancreatitis acute
|
5.6%
1/18
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18
|
0.00%
0/4
|
|
Nervous system disorders
Syncope
|
5.6%
1/18
|
0.00%
0/4
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
5.6%
1/18
|
0.00%
0/4
|
|
General disorders
General physical health deterioration
|
11.1%
2/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18
|
0.00%
0/4
|
|
Nervous system disorders
Epilepsy
|
5.6%
1/18
|
0.00%
0/4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
5.6%
1/18
|
0.00%
0/4
|
|
Psychiatric disorders
Mental disorder
|
5.6%
1/18
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
1/18
|
0.00%
0/4
|
Other adverse events
| Measure |
Ipilimumab, 3 mg/kg
n=18 participants at risk
Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
|
Chemotherapy
n=4 participants at risk
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
5.6%
1/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
5.6%
1/18
|
0.00%
0/4
|
|
General disorders
Pain
|
5.6%
1/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Pancreatitis acute
|
5.6%
1/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/18
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.6%
1/18
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
3/18
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
2/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
6/18
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
1/18
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
2/18
|
25.0%
1/4
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18
|
0.00%
0/4
|
|
Nervous system disorders
Syncope
|
5.6%
1/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diverticulum
|
5.6%
1/18
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
2/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Tongue disorder
|
5.6%
1/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.6%
1/18
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
5.6%
1/18
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/18
|
25.0%
1/4
|
|
Endocrine disorders
Hypopituitarism
|
11.1%
2/18
|
0.00%
0/4
|
|
Infections and infestations
Influenza
|
5.6%
1/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Oesophagitis
|
5.6%
1/18
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.6%
1/18
|
0.00%
0/4
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/18
|
50.0%
2/4
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/18
|
25.0%
1/4
|
|
Infections and infestations
Bronchitis
|
11.1%
2/18
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18
|
0.00%
0/4
|
|
Endocrine disorders
Hypophysitis
|
5.6%
1/18
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18
|
25.0%
1/4
|
|
Infections and infestations
Otitis media
|
5.6%
1/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/18
|
25.0%
1/4
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18
|
25.0%
1/4
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18
|
0.00%
0/4
|
|
Investigations
Blood corticotrophin decreased
|
5.6%
1/18
|
0.00%
0/4
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.6%
1/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
2/18
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
5.6%
1/18
|
0.00%
0/4
|
|
General disorders
Influenza like illness
|
5.6%
1/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/18
|
25.0%
1/4
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/18
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
5.6%
1/18
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.6%
1/18
|
0.00%
0/4
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/18
|
25.0%
1/4
|
|
Investigations
Weight decreased
|
5.6%
1/18
|
0.00%
0/4
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18
|
0.00%
0/4
|
|
General disorders
Asthenia
|
16.7%
3/18
|
25.0%
1/4
|
|
Nervous system disorders
Carpal tunnel syndrome
|
5.6%
1/18
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
2/18
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
1/18
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18
|
0.00%
0/4
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18
|
25.0%
1/4
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18
|
0.00%
0/4
|
|
General disorders
Oedema peripheral
|
11.1%
2/18
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/18
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
1/18
|
0.00%
0/4
|
|
Investigations
Transaminases increased
|
5.6%
1/18
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18
|
25.0%
1/4
|
|
General disorders
Chest pain
|
5.6%
1/18
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18
|
0.00%
0/4
|
|
General disorders
Fatigue
|
22.2%
4/18
|
50.0%
2/4
|
|
Gastrointestinal disorders
Haematochezia
|
11.1%
2/18
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
3/18
|
25.0%
1/4
|
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