MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00094653

First received: October 21, 2004

Last updated: June 29, 2011

Last verified: June 2011

History of Changes

Results First Received: April 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Melanoma Metastases
Interventions:	Drug: MDX-010 (anti-CTLA4) monoclonal antibody Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1783 participants who enrolled and were screened for study participation, a total of 676 subjects were randomized.

Reporting Groups

	Description
Ipilimumab Plus gp100	Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Ipilimumab Monotherapy	Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
gp100	Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

Participant Flow: Overall Study

	Ipilimumab Plus gp100	Ipilimumab Monotherapy	gp100
STARTED	403	137	136
Treated	381	131	131
COMPLETED	82	31	10
NOT COMPLETED	321	106	126
Death	306	100	119
Subject Withdrew Consent	10	2	3
Not specified	2	2	2
Lost to Follow-up	3	2	1
Protocol Violation	0	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Ipilimumab Plus gp100	Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Ipilimumab Monotherapy	Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
gp100	Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Total	Total of all reporting groups

Baseline Measures

	Ipilimumab Plus gp100	Ipilimumab Monotherapy	gp100	Total
Number of Participants [units: participants]	403	137	136	676
Age [units: years] Mean (Full Range)	55.6 (24 to 84)	56.8 (19 to 88)	57.4 (23 to 90)	56.2 (19 to 90)
Age, Customized [units: participants]
< 65 years	291	95	94	480
>=65 years	112	42	42	196
Gender [units: participants]
Female	156	56	63	275
Male	247	81	73	401
Race/Ethnicity, Customized [units: Participants]
White	380	129	129	638
Black	3	1	1	5
Hispanic	18	7	5	30
Other	2	0	1	3
Duration of Melanoma ^[1] [units: years] Mean (Full Range)	5.09 (0.2 to 38.9)	4.34 (-0.0 to 35.9)	5.65 (0.3 to 31.2)	5.05 (-0.0 to 38.9)
Melanoma Stage ^[2] [units: Participants]
M0	5	1	4	10
M1a	37	14	11	62
M1b	76	22	23	121
M1c	285	100	98	483
Prior Interleukin-2 Therapy [units: Participants]
No	314	105	103	522
Yes	89	32	33	154
Lactate Dehydrogenase ^[3] [units: Participants]
>upper limit of normal (ULN)	149	53	52	254
<=ULN	252	84	81	417
unknown	2	0	3	5

[1]	Duration of melanoma is the number of years from date of initial diagnosis to the date of randomization. The randomization of 1 participant in the ipilumumab monotherapy cohort was prior to the initial diagnostic date. Data for 2 participants in the ipilimumab + gp100 cohort were missing.
[2]	The "M" in the TNM (tumor, node, metastasis) system refers to distant metastases—whether, and how far, the cancer has spread outside the original site. M0: There is no evidence that the cancer has spread beyond the original site. M1: The cancer has spread beyond the original site. M1a: The cancer has spread to other areas of skin, underneath the epidermis to the dermis (subcutaneous), or to lymph node(s). M1b: The cancer has spread to the lung(s) only. M1c: The cancer has spread to other organs and/or locations in the body with or without elevated LDH.
[3]	Upper limit of normal (ULN) was 250 U/L for most assessments (some variation caused by tests performed at local laboratories).

Outcome Measures

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1. Primary:

Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

Show Outcome Measure 1

2. Secondary:

Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

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3. Secondary:

12-, 18-, and 24-Month Survival Rates [ Time Frame: Month 12, Month 18, Month 24 ]

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4. Secondary:

Progression Free Survival (PFS) [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

Show Outcome Measure 4

5. Secondary:

Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ]

Show Outcome Measure 5

6. Secondary:

Time to Progression (TTP) [ Time Frame: from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ]

Show Outcome Measure 6

7. Secondary:

Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD) [ Time Frame: BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. ]

Show Outcome Measure 7

8. Secondary:

Determination of Best Overall Response Rate (BORR) [ Time Frame: Up to week 24 ]

Show Outcome Measure 8

9. Secondary:

Time to Response [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

Show Outcome Measure 9

10. Secondary:

Duration of Response [ Time Frame: from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ]

Show Outcome Measure 10

11. Secondary:

Disease Control Rate (DCR) [ Time Frame: Up to week 24 ]

Show Outcome Measure 11

12. Secondary:

Delayed Response (Response Beyond Week 24) [ Time Frame: from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12 [ Time Frame: Baseline (Day 1, Cycle1), Week 12 ]

Show Outcome Measure 13

14. Secondary:

Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

Show Outcome Measure 14

15. Secondary:

Percentage of Participants With Immune-Related Adverse Events (irAEs) [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

Show Outcome Measure 15

16. Secondary:

Percentage of Participants With Worst On-Study Hematological Abnormalities [ Time Frame: On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

Show Outcome Measure 16

17. Secondary:

Percentage of Participants With Worst On-Study Liver Abnormalities [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

Show Outcome Measure 17

18. Secondary:

Percentage of Participants With Worst On-Study Renal Abnormalities [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

Show Outcome Measure 18

19. Secondary:

Clinically Meaningful Changes in Vital Signs and Physical Examinations [ Time Frame: vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter ]

Show Outcome Measure 19

Serious Adverse Events

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Reporting Groups

	Description
Ipilimumab Monotherapy	Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Ipilimumab Plus gp100	Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
gp100	Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

Serious Adverse Events

	Ipilimumab Monotherapy	Ipilimumab Plus gp100	gp100
Total, serious adverse events
# participants affected / at risk	55/131 (41.98%)	155/380 (40.79%)	52/132 (39.39%)
Blood and lymphatic system disorders
ANAEMIA ^{† 1}
# participants affected / at risk	4/131 (3.05%)	5/380 (1.32%)	5/132 (3.79%)
HAEMOLYTIC ANAEMIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
LEUKOCYTOSIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
NEUTROPENIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
THROMBOCYTOPENIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
Cardiac disorders
ATRIAL FIBRILLATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
CARDIAC FAILURE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
CARDIAC FAILURE CONGESTIVE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
CARDIAC TAMPONADE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
CARDIOPULMONARY FAILURE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
CORONARY ARTERY DISEASE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
PERICARDIAL EFFUSION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
SUPRAVENTRICULAR TACHYCARDIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
TACHYCARDIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Endocrine disorders
ADRENAL INSUFFICIENCY ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
HYPOGONADISM ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HYPOPHYSITIS ^{† 1}
# participants affected / at risk	2/131 (1.53%)	1/380 (0.26%)	0/132 (0.00%)
HYPOPITUITARISM ^{† 1}
# participants affected / at risk	2/131 (1.53%)	3/380 (0.79%)	0/132 (0.00%)
HYPOTHYROIDISM ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Eye disorders
IRIDOCYCLITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Gastrointestinal disorders
ABDOMINAL DISTENSION ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
ABDOMINAL PAIN ^{† 1}
# participants affected / at risk	2/131 (1.53%)	4/380 (1.05%)	5/132 (3.79%)
ABDOMINAL PAIN UPPER ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
ABDOMINAL WALL MASS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
ASCITES ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
COLITIS ^{† 1}
# participants affected / at risk	7/131 (5.34%)	14/380 (3.68%)	0/132 (0.00%)
CONSTIPATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	3/380 (0.79%)	1/132 (0.76%)
DIARRHOEA ^{† 1}
# participants affected / at risk	6/131 (4.58%)	16/380 (4.21%)	0/132 (0.00%)
DYSPHAGIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	1/132 (0.76%)
GASTRITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
GASTROINTESTINAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
GASTROINTESTINAL PERFORATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HAEMATOCHEZIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
HAEMORRHOIDS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
ILEUS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	3/380 (0.79%)	0/132 (0.00%)
INTESTINAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
INTESTINAL OBSTRUCTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
INTESTINAL PERFORATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	3/380 (0.79%)	0/132 (0.00%)
INTUSSUSCEPTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	2/132 (1.52%)
LARGE INTESTINAL OBSTRUCTION ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
LARGE INTESTINE PERFORATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
NAUSEA ^{† 1}
# participants affected / at risk	2/131 (1.53%)	6/380 (1.58%)	4/132 (3.03%)
PERITONITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
PROCTALGIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
RECTAL STENOSIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
SMALL INTESTINAL OBSTRUCTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
UPPER GASTROINTESTINAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
VOMITING ^{† 1}
# participants affected / at risk	3/131 (2.29%)	7/380 (1.84%)	3/132 (2.27%)
General disorders
ADVERSE EVENT ^{† 1}
# participants affected / at risk	1/131 (0.76%)	3/380 (0.79%)	0/132 (0.00%)
ASTHENIA ^{† 1}
# participants affected / at risk	3/131 (2.29%)	4/380 (1.05%)	1/132 (0.76%)
CHEST PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
CHILLS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
DISEASE PROGRESSION ^{† 1}
# participants affected / at risk	2/131 (1.53%)	6/380 (1.58%)	3/132 (2.27%)
FATIGUE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
GAIT DISTURBANCE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	1/132 (0.76%)
GENERAL PHYSICAL HEALTH DETERIORATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	2/132 (1.52%)
GENERALISED OEDEMA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
HERNIA OBSTRUCTIVE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
INFLUENZA LIKE ILLNESS ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
INFUSION RELATED REACTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
INJECTION SITE REACTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
INJECTION SITE ULCER ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
MULTI-ORGAN FAILURE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	2/132 (1.52%)
OEDEMA ^{† 1}
# participants affected / at risk	2/131 (1.53%)	1/380 (0.26%)	0/132 (0.00%)
OEDEMA PERIPHERAL ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
PAIN ^{† 1}
# participants affected / at risk	1/131 (0.76%)	3/380 (0.79%)	0/132 (0.00%)
PYREXIA ^{† 1}
# participants affected / at risk	2/131 (1.53%)	7/380 (1.84%)	1/132 (0.76%)
Hepatobiliary disorders
ACUTE HEPATIC FAILURE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
BILE DUCT OBSTRUCTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
CHOLECYSTITIS ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
HEPATIC FAILURE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
HEPATITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HYPERBILIRUBINAEMIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
JAUNDICE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
JAUNDICE CHOLESTATIC ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Infections and infestations
APPENDICITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
BACTERAEMIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
BRONCHOPNEUMONIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
CATHETER RELATED INFECTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
CELLULITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
CYSTITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
ENTEROCOCCAL BACTERAEMIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
ERYSIPELAS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
EYELID INFECTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
GASTROINTESTINAL INFECTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HEPATITIS A ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
HEPATITIS B ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
INFECTION ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
LOCALISED INFECTION ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
LOWER RESPIRATORY TRACT INFECTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
MENINGITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
PERIRECTAL ABSCESS ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
PNEUMONIA ^{† 1}
# participants affected / at risk	2/131 (1.53%)	8/380 (2.11%)	3/132 (2.27%)
POSTOPERATIVE WOUND INFECTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
PSEUDOMONAL SEPSIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
SEPSIS ^{† 1}
# participants affected / at risk	3/131 (2.29%)	4/380 (1.05%)	0/132 (0.00%)
SEPTIC SHOCK ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	1/132 (0.76%)
URINARY TRACT INFECTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	3/132 (2.27%)
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
FEMORAL NECK FRACTURE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
GASTROINTESTINAL STOMA COMPLICATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HIP FRACTURE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
PROCEDURAL COMPLICATION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
BLOOD CORTICOTROPHIN DECREASED ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
GAMMA-GLUTAMYLTRANSFERASE INCREASED ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
INTERNATIONAL NORMALISED RATIO ABNORMAL ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
URINE OUTPUT DECREASED ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
Metabolism and nutrition disorders
DECREASED APPETITE ^{† 1}
# participants affected / at risk	2/131 (1.53%)	3/380 (0.79%)	1/132 (0.76%)
DEHYDRATION ^{† 1}
# participants affected / at risk	1/131 (0.76%)	8/380 (2.11%)	4/132 (3.03%)
FAILURE TO THRIVE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
HYPOALBUMINAEMIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
HYPOGLYCAEMIA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
HYPONATRAEMIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HYPOPHAGIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
MALNUTRITION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
TUMOUR LYSIS SYNDROME ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
BACK PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	2/132 (1.52%)
BONE PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
MUSCULAR WEAKNESS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
MUSCULOSKELETAL PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
NECK PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
PAIN IN EXTREMITY ^{† 1}
# participants affected / at risk	0/131 (0.00%)	3/380 (0.79%)	1/132 (0.76%)
PATHOLOGICAL FRACTURE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
POLYMYALGIA RHEUMATICA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
CANCER PAIN ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
INTRACRANIAL TUMOUR HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
MALIGNANT ASCITES ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
MALIGNANT MELANOMA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	3/380 (0.79%)	1/132 (0.76%)
MALIGNANT NEOPLASM PROGRESSION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	3/380 (0.79%)	0/132 (0.00%)
METASTASES TO BREAST ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
METASTASES TO CENTRAL NERVOUS SYSTEM ^{† 1}
# participants affected / at risk	2/131 (1.53%)	3/380 (0.79%)	0/132 (0.00%)
METASTASES TO SPINE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
METASTATIC MALIGNANT MELANOMA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
METASTATIC NEOPLASM ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
METASTATIC PAIN ^{† 1}
# participants affected / at risk	1/131 (0.76%)	3/380 (0.79%)	0/132 (0.00%)
TUMOUR HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	2/132 (1.52%)
TUMOUR PAIN ^{† 1}
# participants affected / at risk	2/131 (1.53%)	2/380 (0.53%)	1/132 (0.76%)
Nervous system disorders
APHASIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
ATAXIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
BRAIN OEDEMA ^{† 1}
# participants affected / at risk	1/131 (0.76%)	2/380 (0.53%)	0/132 (0.00%)
CEREBRAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	2/132 (1.52%)
CEREBROVASCULAR ACCIDENT ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
COMA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
CONVULSION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
DEPRESSED LEVEL OF CONSCIOUSNESS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
DIZZINESS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	2/132 (1.52%)
DYSARTHRIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
EPIDURITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
GUILLAIN-BARRE SYNDROME ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HAEMORRHAGE INTRACRANIAL ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
HEADACHE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	1/132 (0.76%)
HYDROCEPHALUS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HYPOAESTHESIA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
INTRACRANIAL PRESSURE INCREASED ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
LETHARGY ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
MENINGEAL DISORDER ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
MYOCLONUS ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
SPINAL CORD COMPRESSION ^{† 1}
# participants affected / at risk	1/131 (0.76%)	3/380 (0.79%)	0/132 (0.00%)
SYNCOPE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)
Psychiatric disorders
ANXIETY ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
CONFUSIONAL STATE ^{† 1}
# participants affected / at risk	2/131 (1.53%)	1/380 (0.26%)	1/132 (0.76%)
DELIRIUM ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
MENTAL STATUS CHANGES ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
Renal and urinary disorders
ATONIC URINARY BLADDER ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
BLADDER PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
GLOMERULONEPHRITIS ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
HYDRONEPHROSIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
RENAL FAILURE ^{† 1}
# participants affected / at risk	3/131 (2.29%)	3/380 (0.79%)	0/132 (0.00%)
RENAL FAILURE ACUTE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
RENAL TUBULAR NECROSIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
URETERIC OBSTRUCTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
URINARY INCONTINENCE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
URINARY RETENTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
Reproductive system and breast disorders
BREAST MASS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
PELVIC PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
ACUTE RESPIRATORY DISTRESS SYNDROME ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
BRONCHIAL OBSTRUCTION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
COUGH ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
DYSPNOEA ^{† 1}
# participants affected / at risk	3/131 (2.29%)	2/380 (0.53%)	7/132 (5.30%)
HAEMOPTYSIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
HAEMOTHORAX ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
PAINFUL RESPIRATION ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
PLEURAL EFFUSION ^{† 1}
# participants affected / at risk	2/131 (1.53%)	5/380 (1.32%)	4/132 (3.03%)
PLEURITIC PAIN ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
PNEUMONITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
PULMONARY EMBOLISM ^{† 1}
# participants affected / at risk	1/131 (0.76%)	3/380 (0.79%)	2/132 (1.52%)
PULMONARY HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
RESPIRATORY ARREST ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
RESPIRATORY DEPRESSION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
RESPIRATORY FAILURE ^{† 1}
# participants affected / at risk	1/131 (0.76%)	2/380 (0.53%)	0/132 (0.00%)
SLEEP APNOEA SYNDROME ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
Skin and subcutaneous tissue disorders
LEUKOCYTOCLASTIC VASCULITIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
RASH ^{† 1}
# participants affected / at risk	0/131 (0.00%)	2/380 (0.53%)	0/132 (0.00%)
RASH GENERALISED ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
RASH PRURITIC ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
TOXIC EPIDERMAL NECROLYSIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
Vascular disorders
ANGIOPATHY ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
ARTERIAL THROMBOSIS LIMB ^{† 1}
# participants affected / at risk	1/131 (0.76%)	0/380 (0.00%)	0/132 (0.00%)
DEEP VEIN THROMBOSIS ^{† 1}
# participants affected / at risk	2/131 (1.53%)	5/380 (1.32%)	1/132 (0.76%)
HAEMATOMA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	1/132 (0.76%)
HYPERTENSIVE CRISIS ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
HYPOTENSION ^{† 1}
# participants affected / at risk	3/131 (2.29%)	1/380 (0.26%)	2/132 (1.52%)
LYMPHOEDEMA ^{† 1}
# participants affected / at risk	0/131 (0.00%)	0/380 (0.00%)	1/132 (0.76%)
SUPERIOR VENA CAVAL OCCLUSION ^{† 1}
# participants affected / at risk	0/131 (0.00%)	1/380 (0.26%)	0/132 (0.00%)
THROMBOSIS ^{† 1}
# participants affected / at risk	1/131 (0.76%)	1/380 (0.26%)	0/132 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 12.1

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Results Point of Contact:

Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com

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

Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D. The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK. PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524. eCollection 2015.

Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS. Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab. Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303.

Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.

Hatswell AJ, Pennington B, Pericleous L, Rowen D, Lebmeier M, Lee D. Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death. Health Qual Life Outcomes. 2014 Sep 10;12:140. doi: 10.1186/s12955-014-0140-1.

McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S; MDX010-20 Investigators. Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol. 2013 Oct;24(10):2694-8. doi: 10.1093/annonc/mdt291. Epub 2013 Aug 13.

Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013 Apr 15;19(8):2232-9. doi: 10.1158/1078-0432.CCR-12-3080. Epub 2013 Feb 26.

Weber JS, Dummer R, de Pril V, Lebbé C, Hodi FS; MDX010-20 Investigators. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013 May 1;119(9):1675-82. doi: 10.1002/cncr.27969. Epub 2013 Feb 7.

Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, Kotapati S. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.

Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbé C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5. Erratum in: N Engl J Med. 2010 Sep 23;363(13):1290.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00094653 History of Changes
Other Study ID Numbers:	MDX010-20 CA184-002 ( Other Identifier: BMS )
Study First Received:	October 21, 2004
Results First Received:	April 22, 2011
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration

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