Trial record 2 of 6 for: sargramostim ipilimumab melanoma

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Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT01134614

Recruitment Status : Active, not recruiting

First Posted : June 2, 2010

Results First Posted : April 2, 2015

Last Update Posted : April 14, 2021

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Advanced Melanoma Metastatic Melanoma Recurrent Melanoma Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Unresectable Melanoma
Interventions	Biological: Ipilimumab Biological: Sargramostim
Enrollment	245

Participant Flow

Recruitment Details	Participants were enrolled from ECOG member institutions between December 28, 2010 and July 28, 2011.
Pre-assignment Details


Arm/Group Title	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
Arm/Group Description	ARM A: Patients receive induction t...	ARM B: Patients receive induction t...
Arm/Group Description	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: 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
Period Title: Overall Study
Started	123	122
Treated	119	121
Treated and Toxicity Assessed	118	120
Completed	0 ^[1]	0 ^[2]
Not Completed	123	122
Reason Not Completed
Still on treatment as of March 2013	21	13
Progressive disease	60	54
Adverse Event	26	39
Death	5	8
Withdrawal by Subject	3	2
Alternative therapy	2	0
Complicating disease	2	1
Physician's decision	0	1
Never started treatment	4	1
Pt received tx not allowed on study	0	1
Symptomatic deterioration	0	1
Patient in hospice care	0	1
[1] Treatment continues until disease progression or unacceptable toxicity. [2] Treatment continues until disease progression or unacceptable toxicities

Baseline Characteristics

Arm/Group Title		Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)	Total
Arm/Group Description		ARM A: Patients receive induction t...	ARM B: Patients receive induction t...	Total of all reporting groups
Arm/Group Description		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: 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 of all reporting groups
Overall Number of Baseline Participants		123	122	245
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All randomized patients are included in this analysis.
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	123 participants	122 participants	245 participants
		61 (25 to 86)	64 (21 to 89)	63 (21 to 89)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	123 participants	122 participants	245 participants
	Female	38 30.9%	44 36.1%	82 33.5%
	Male	85 69.1%	78 63.9%	163 66.5%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	123 participants	122 participants	245 participants
United States		123	122	245

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	Overall survival is defined as the time from randomization to death fr...
Description	Overall survival is defined as the time from randomization to death from any cause.
Time Frame	Assessed every 3 months for 2 years, then every 6 months for 3 years

Outcome Measure Data

Analysis Population Description

All randomized patients are included in this analysis.


Arm/Group Title	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
Arm/Group Description:	ARM A: Patients receive induction t...	ARM B: Patients receive induction t...
Arm/Group Description:	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: 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 Number of Participants Analyzed	123	122
Median (95% Confidence Interval) Unit of Measure: Months
	17.5 ^[1] (14.9 to NA)	12.7 ^[1] (10.0 to NA)

[1]

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.

2.Secondary Outcome


Title	Progression-free Survival (PFS)
Description	Progression-free survival is defined as the time from randomization to...
Description	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.
Time Frame	Assessed every 3 months for 2 years, then every 6 months for 3 years

Outcome Measure Data

Analysis Population Description

All randomized patients are included in this analysis.


Arm/Group Title	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
Arm/Group Description:	ARM A: Patients receive induction t...	ARM B: Patients receive induction t...
Arm/Group Description:	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: 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 Number of Participants Analyzed	123	122
Median (95% Confidence Interval) Unit of Measure: Months
	3.1 (2.9 to 4.6)	3.1 (2.9 to 4.0)

3.Secondary Outcome


Title	Proportion of Patients With Objective Response
Description	Objective response was evaluated using RECIST (Response Evaluation Cri...
Description	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.
Time Frame	Assessed every 3 months for 2 years, then every 6 months for 3 years

Outcome Measure Data

Analysis Population Description

All randomized patients are included in this analysis.


Arm/Group Title	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
Arm/Group Description:	ARM A: Patients receive induction t...	ARM B: Patients receive induction t...
Arm/Group Description:	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: 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 Number of Participants Analyzed	123	122
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Proportion of patients
	0.155 (0.096 to 0.231)	0.148 (0.090 to 0.223)

Adverse Events

Time Frame	Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
Arm/Group Description	ARM A: Patients receive induction t...	ARM B: Patients receive induction t...
Arm/Group Description	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: 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.
All-Cause Mortality
	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	56/118 (47.46%)	69/120 (57.50%)
Blood and lymphatic system disorders
Anemia ^† 1	0/118 (0.00%)	1/120 (0.83%)
Febrile neutropenia ^† 1	1/118 (0.85%)	0/120 (0.00%)
Cardiac disorders
Cardiac arrest ^† 1	1/118 (0.85%)	0/120 (0.00%)
Ventricular tachycardia ^† 1	0/118 (0.00%)	1/120 (0.83%)
Endocrine disorders
Adrenal insufficiency ^† 1	2/118 (1.69%)	2/120 (1.67%)
Hyperthyroidism ^† 1	0/118 (0.00%)	1/120 (0.83%)
Hypothyroidism ^† 1	0/118 (0.00%)	2/120 (1.67%)
Endocrine disorders - Other, specify ^† 1	3/118 (2.54%)	5/120 (4.17%)
Eye disorders
Eye disorders - Other, specify ^† 1	1/118 (0.85%)	2/120 (1.67%)
Gastrointestinal disorders
Abdominal distension ^† 1	0/118 (0.00%)	1/120 (0.83%)
Abdominal pain ^† 1	1/118 (0.85%)	4/120 (3.33%)
Colitis ^† 1	7/118 (5.93%)	12/120 (10.00%)
Colonic hemorrhage ^† 1	1/118 (0.85%)	0/120 (0.00%)
Colonic perforation ^† 1	2/118 (1.69%)	7/120 (5.83%)
Diarrhea ^† 1	14/118 (11.86%)	15/120 (12.50%)
Enterocolitis ^† 1	0/118 (0.00%)	1/120 (0.83%)
Nausea ^† 1	3/118 (2.54%)	4/120 (3.33%)
Rectal hemorrhage ^† 1	0/118 (0.00%)	1/120 (0.83%)
Vomiting ^† 1	1/118 (0.85%)	3/120 (2.50%)
General disorders
Fatigue ^† 1	7/118 (5.93%)	4/120 (3.33%)
Fever ^† 1	1/118 (0.85%)	0/120 (0.00%)
Infusion related reaction ^† 1	0/118 (0.00%)	1/120 (0.83%)
Injection site reaction ^† 1	2/118 (1.69%)	0/120 (0.00%)
Multi-organ failure ^† 1	0/118 (0.00%)	2/120 (1.67%)
Pain ^† 1	0/118 (0.00%)	1/120 (0.83%)
Hepatobiliary disorders
Hepatic failure ^† 1	0/118 (0.00%)	1/120 (0.83%)
Hepatobiliary disorders - Other, specify ^† 1	1/118 (0.85%)	0/120 (0.00%)
Immune system disorders
Allergic reaction ^† 1	1/118 (0.85%)	0/120 (0.00%)
Autoimmune disorder ^† 1	0/118 (0.00%)	5/120 (4.17%)
Immune system disorders - Other, specify ^† 1	0/118 (0.00%)	1/120 (0.83%)
Infections and infestations
Enterocolitis infectious ^† 1	1/118 (0.85%)	1/120 (0.83%)
Kidney infection ^† 1	0/118 (0.00%)	1/120 (0.83%)
Lung infection ^† 1	0/118 (0.00%)	2/120 (1.67%)
Sepsis ^† 1	1/118 (0.85%)	0/120 (0.00%)
Injury, poisoning and procedural complications
Fall ^† 1	1/118 (0.85%)	0/120 (0.00%)
Investigations
Activated PTT prolonged ^† 1	0/118 (0.00%)	1/120 (0.83%)
Alanine aminotransferase increased ^† 1	6/118 (5.08%)	8/120 (6.67%)
Alkaline phosphatase increased ^† 1	0/118 (0.00%)	3/120 (2.50%)
Aspartate aminotransferase increased ^† 1	5/118 (4.24%)	9/120 (7.50%)
Blood bilirubin increased ^† 1	0/118 (0.00%)	4/120 (3.33%)
Creatinine increased ^† 1	1/118 (0.85%)	0/120 (0.00%)
INR increased ^† 1	0/118 (0.00%)	1/120 (0.83%)
Lipase increased ^† 1	6/118 (5.08%)	6/120 (5.00%)
Lymphocyte count decreased ^† 1	1/118 (0.85%)	2/120 (1.67%)
Neutrophil count decreased ^† 1	2/118 (1.69%)	1/120 (0.83%)
Platelet count decreased ^† 1	2/118 (1.69%)	2/120 (1.67%)
Serum amylase increased ^† 1	2/118 (1.69%)	1/120 (0.83%)
White blood cell decreased ^† 1	0/118 (0.00%)	1/120 (0.83%)
Investigations - Other, specify ^† 1	0/118 (0.00%)	1/120 (0.83%)
Metabolism and nutrition disorders
Anorexia ^† 1	2/118 (1.69%)	2/120 (1.67%)
Dehydration ^† 1	5/118 (4.24%)	5/120 (4.17%)
Hyperkalemia ^† 1	1/118 (0.85%)	0/120 (0.00%)
Hyperuricemia ^† 1	2/118 (1.69%)	0/120 (0.00%)
Hypoalbuminemia ^† 1	0/118 (0.00%)	2/120 (1.67%)
Hypokalemia ^† 1	2/118 (1.69%)	0/120 (0.00%)
Hyponatremia ^† 1	5/118 (4.24%)	3/120 (2.50%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	2/118 (1.69%)	1/120 (0.83%)
Arthritis ^† 1	1/118 (0.85%)	0/120 (0.00%)
Back pain ^† 1	0/118 (0.00%)	1/120 (0.83%)
Bone pain ^† 1	0/118 (0.00%)	1/120 (0.83%)
Generalized muscle weakness ^† 1	2/118 (1.69%)	4/120 (3.33%)
Joint range of motion decreased ^† 1	1/118 (0.85%)	1/120 (0.83%)
Muscle weakness lower limb ^† 1	1/118 (0.85%)	1/120 (0.83%)
Myalgia ^† 1	1/118 (0.85%)	1/120 (0.83%)
Pain in extremity ^† 1	1/118 (0.85%)	0/120 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain ^† 1	0/118 (0.00%)	1/120 (0.83%)
Nervous system disorders
Headache ^† 1	2/118 (1.69%)	0/120 (0.00%)
Syncope ^† 1	2/118 (1.69%)	0/120 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	0/118 (0.00%)	1/120 (0.83%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^† 1	0/118 (0.00%)	2/120 (1.67%)
Hypoxia ^† 1	0/118 (0.00%)	1/120 (0.83%)
Pleural effusion ^† 1	0/118 (0.00%)	1/120 (0.83%)
Pneumonitis ^† 1	0/118 (0.00%)	2/120 (1.67%)
Respiratory failure ^† 1	0/118 (0.00%)	3/120 (2.50%)
Skin and subcutaneous tissue disorders
Dry skin ^† 1	1/118 (0.85%)	0/120 (0.00%)
Pruritus ^† 1	4/118 (3.39%)	7/120 (5.83%)
Rash acneiform ^† 1	0/118 (0.00%)	1/120 (0.83%)
Rash maculo-papular ^† 1	14/118 (11.86%)	11/120 (9.17%)
Urticaria ^† 1	1/118 (0.85%)	1/120 (0.83%)
Vascular disorders
Hypertension ^† 1	0/118 (0.00%)	2/120 (1.67%)
Hypotension ^† 1	2/118 (1.69%)	2/120 (1.67%)
Thromboembolic event ^† 1	1/118 (0.85%)	1/120 (0.83%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE 4.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Arm A (Ipilimumab and Sargramostim)	Arm B (Ipilimumab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	110/118 (93.22%)	111/120 (92.50%)
Blood and lymphatic system disorders
Anemia ^† 1	22/118 (18.64%)	24/120 (20.00%)
Endocrine disorders
Adrenal insufficiency ^† 1	7/118 (5.93%)	2/120 (1.67%)
Hypothyroidism ^† 1	11/118 (9.32%)	6/120 (5.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	20/118 (16.95%)	16/120 (13.33%)
Constipation ^† 1	7/118 (5.93%)	9/120 (7.50%)
Diarrhea ^† 1	46/118 (38.98%)	46/120 (38.33%)
Nausea ^† 1	36/118 (30.51%)	31/120 (25.83%)
Vomiting ^† 1	10/118 (8.47%)	6/120 (5.00%)
General disorders
Chills ^† 1	18/118 (15.25%)	8/120 (6.67%)
Edema limbs ^† 1	10/118 (8.47%)	4/120 (3.33%)
Fatigue ^† 1	70/118 (59.32%)	75/120 (62.50%)
Fever ^† 1	17/118 (14.41%)	18/120 (15.00%)
Injection site reaction ^† 1	62/118 (52.54%)	0/120 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	13/118 (11.02%)	18/120 (15.00%)
Alkaline phosphatase increased ^† 1	12/118 (10.17%)	12/120 (10.00%)
Aspartate aminotransferase increased ^† 1	16/118 (13.56%)	21/120 (17.50%)
Blood bilirubin increased ^† 1	6/118 (5.08%)	6/120 (5.00%)
Creatinine increased ^† 1	6/118 (5.08%)	8/120 (6.67%)
Lipase increased ^† 1	13/118 (11.02%)	7/120 (5.83%)
Lymphocyte count decreased ^† 1	6/118 (5.08%)	9/120 (7.50%)
Platelet count decreased ^† 1	9/118 (7.63%)	4/120 (3.33%)
Weight loss ^† 1	16/118 (13.56%)	17/120 (14.17%)
Investigations - Other, specify ^† 1	7/118 (5.93%)	7/120 (5.83%)
Metabolism and nutrition disorders
Anorexia ^† 1	25/118 (21.19%)	33/120 (27.50%)
Hyperuricemia ^† 1	6/118 (5.08%)	1/120 (0.83%)
Hypoalbuminemia ^† 1	7/118 (5.93%)	6/120 (5.00%)
Hypocalcemia ^† 1	6/118 (5.08%)	2/120 (1.67%)
Hyponatremia ^† 1	9/118 (7.63%)	4/120 (3.33%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	20/118 (16.95%)	13/120 (10.83%)
Back pain ^† 1	10/118 (8.47%)	10/120 (8.33%)
Bone pain ^† 1	8/118 (6.78%)	2/120 (1.67%)
Myalgia ^† 1	9/118 (7.63%)	5/120 (4.17%)
Pain in extremity ^† 1	8/118 (6.78%)	1/120 (0.83%)
Nervous system disorders
Dizziness ^† 1	11/118 (9.32%)	5/120 (4.17%)
Dysgeusia ^† 1	7/118 (5.93%)	7/120 (5.83%)
Headache ^† 1	23/118 (19.49%)	10/120 (8.33%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	6/118 (5.08%)	10/120 (8.33%)
Dyspnea ^† 1	9/118 (7.63%)	11/120 (9.17%)
Skin and subcutaneous tissue disorders
Pruritus ^† 1	50/118 (42.37%)	54/120 (45.00%)
Rash maculo-papular ^† 1	62/118 (52.54%)	57/120 (47.50%)
Skin and subcutaneous tissue - Other ^† 1	7/118 (5.93%)	1/120 (0.83%)
Vascular disorders
Hot flashes ^† 1	8/118 (6.78%)	7/120 (5.83%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE 4.0

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Study Statistician
Organization:	ECOG Statistical Office
Phone:	617-632-3012

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hodi FS, Lee S, McDermott DF, Rao UN, Butterfield LH, Tarhini AA, Leming P, Puzanov I, Shin D, Kirkwood JM. Ipilimumab plus sargramostim vs ipilimumab alone for treatment of metastatic melanoma: a randomized clinical trial. JAMA. 2014 Nov 5;312(17):1744-53. doi: 10.1001/jama.2014.13943.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01134614
Other Study ID Numbers:	NCI-2011-02039 NCI-2011-02039 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000671238 E1608 11-01460 E1608 ( Other Identifier: ECOG-ACRIN Cancer Research Group ) E1608 ( Other Identifier: CTEP ) U10CA180820 ( U.S. NIH Grant/Contract ) U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted:	April 27, 2010
First Posted:	June 2, 2010
Results First Submitted:	March 23, 2015
Results First Posted:	April 2, 2015
Last Update Posted:	April 14, 2021

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