Trial Outcomes & Findings for Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery (NCT NCT01134614)
NCT ID: NCT01134614
Last Updated: 2025-11-14
Results Overview
Overall survival is defined as the time from randomization to death from any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
245 participants
Primary outcome timeframe
Assessed every 3 months for 2 years, then every 6 months for 3 years
Results posted on
2025-11-14
Participant Flow
Participants were enrolled from ECOG member institutions between December 28, 2010 and July 28, 2011.
Participant milestones
| Measure |
Arm A (Ipilimumab and Sargramostim)
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC
|
Arm B (Ipilimumab)
ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
122
|
|
Overall Study
Treated
|
119
|
121
|
|
Overall Study
Treated and Toxicity Assessed
|
118
|
120
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
123
|
122
|
Reasons for withdrawal
| Measure |
Arm A (Ipilimumab and Sargramostim)
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC
|
Arm B (Ipilimumab)
ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV
|
|---|---|---|
|
Overall Study
Still on treatment as of March 2013
|
21
|
13
|
|
Overall Study
Progressive disease
|
60
|
54
|
|
Overall Study
Adverse Event
|
26
|
39
|
|
Overall Study
Death
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Alternative therapy
|
2
|
0
|
|
Overall Study
Complicating disease
|
2
|
1
|
|
Overall Study
Physician's decision
|
0
|
1
|
|
Overall Study
Never started treatment
|
4
|
1
|
|
Overall Study
Pt received tx not allowed on study
|
0
|
1
|
|
Overall Study
Symptomatic deterioration
|
0
|
1
|
|
Overall Study
Patient in hospice care
|
0
|
1
|
Baseline Characteristics
Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm A (Ipilimumab and Sargramostim)
n=123 Participants
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC
|
Arm B (Ipilimumab)
n=122 Participants
ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=10 Participants
|
64 years
n=10 Participants
|
63 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=10 Participants
|
44 Participants
n=10 Participants
|
82 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=10 Participants
|
78 Participants
n=10 Participants
|
163 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=10 Participants
|
122 participants
n=10 Participants
|
245 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 yearsPopulation: All randomized patients are included in this analysis.
Overall survival is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Arm A (Ipilimumab and Sargramostim)
n=123 Participants
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC
|
Arm B (Ipilimumab)
n=122 Participants
ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV
|
|---|---|---|
|
Overall Survival
|
17.5 Months
Interval 14.9 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
12.7 Months
Interval 10.0 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 yearsPopulation: All randomized patients are included in this analysis.
Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as \>= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.
Outcome measures
| Measure |
Arm A (Ipilimumab and Sargramostim)
n=123 Participants
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC
|
Arm B (Ipilimumab)
n=122 Participants
ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.1 Months
Interval 2.9 to 4.6
|
3.1 Months
Interval 2.9 to 4.0
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 yearsPopulation: All randomized patients are included in this analysis.
Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR.
Outcome measures
| Measure |
Arm A (Ipilimumab and Sargramostim)
n=123 Participants
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC
|
Arm B (Ipilimumab)
n=122 Participants
ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV
|
|---|---|---|
|
Proportion of Patients With Objective Response
|
0.155 Proportion of patients
Interval 0.096 to 0.231
|
0.148 Proportion of patients
Interval 0.09 to 0.223
|
Adverse Events
Arm A (Ipilimumab and Sargramostim)
Serious events: 56 serious events
Other events: 110 other events
Deaths: 0 deaths
Arm B (Ipilimumab)
Serious events: 69 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Ipilimumab and Sargramostim)
n=118 participants at risk
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
|
Arm B (Ipilimumab)
n=120 participants at risk
ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Infusion related reaction
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Injection site reaction
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Multi-organ failure
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Pain
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
4/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
7/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.9%
14/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.2%
11/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.5%
3/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
4.2%
5/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colitis
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
10.0%
12/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colonic perforation
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
7/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
11.9%
14/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
12.5%
15/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
2.5%
3/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
2.5%
3/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Allergic reaction
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
4.2%
5/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Enterocolitis infectious
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Kidney infection
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Lung infection
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Sepsis
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Activated PTT prolonged
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
8/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
2.5%
3/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
5/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
9/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
INR increased
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lipase increased
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.0%
6/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Serum amylase increased
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
5/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
4.2%
5/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
5/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
2.5%
3/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
2.5%
3/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thromboembolic event
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (Ipilimumab and Sargramostim)
n=118 participants at risk
ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
|
Arm B (Ipilimumab)
n=120 participants at risk
ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.6%
22/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
20.0%
24/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
15.3%
18/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
8/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limbs
|
8.5%
10/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
59.3%
70/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
62.5%
75/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
14.4%
17/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
15.0%
18/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Injection site reaction
|
52.5%
62/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
42.4%
50/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
45.0%
54/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
52.5%
62/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
47.5%
57/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue - Other
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Endocrine disorders
Hypothyroidism
|
9.3%
11/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.0%
6/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
16.9%
20/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.3%
16/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
9/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
39.0%
46/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
38.3%
46/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
30.5%
36/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
25.8%
31/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
10/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.0%
6/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
11.0%
13/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
15.0%
18/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
10.2%
12/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
10.0%
12/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
16/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
17.5%
21/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.0%
6/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
8/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lipase increased
|
11.0%
13/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
7/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
9/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
7.6%
9/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
13.6%
16/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
14.2%
17/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Investigations - Other, specify
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
7/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
21.2%
25/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
27.5%
33/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.0%
6/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.6%
9/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
4/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
20/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
10.8%
13/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
10/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
8.3%
10/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.8%
8/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.7%
2/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.6%
9/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
4.2%
5/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
8/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.83%
1/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
9.3%
11/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
4.2%
5/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
7/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
19.5%
23/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
8.3%
10/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
8.3%
10/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.6%
9/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.2%
11/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hot flashes
|
6.8%
8/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
7/120 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60