A Phase 3 interventional study of Nivolumab and Ipilimumab in Melanoma, sponsored by Bristol-Myers Squibb. Completed at 111 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-15.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 533 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.
Exclusion Criteria:
Nivolumab + Ipilimumab specified dose on specified days
Drug: Nivolumab · Drug: Ipilimumab
Nivolumab specified dose on specified days
Drug: Nivolumab
Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Onset (Grades 3-4) of Select Adverse Events
Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Time to Resolution of an Adverse Event (AE)
Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Overall Survival (OS)
Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive
Time frame: Up to approximately 37 months
Incidence of Participants With Adverse Events
The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Select Adverse Events
The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Liver
Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Thyroid
Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants
Time frame: Up to approximately 37 months
Progression Free Survival (PFS)
Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
Time frame: Up to approximately 37 months
| Milestone | Nivolumab + Ipilimumab Total |
|---|---|
| Started | 533 |
| Completed | 0 |
| Not completed | 533 |
| Withdrew: Disease progression | 153 |
| Withdrew: Study drug toxicity | 201 |
| Withdrew: Death | 26 |
| Withdrew: Adverse event unrelated to study drug | 23 |
| Withdrew: Participant request to discontinue study treatment | 13 |
| Withdrew: Participant withdrew consent | 5 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Maximum clinical benefit | 7 |
| Withdrew: Poor/non-compliance | 1 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Participant no longer met study criteria | 7 |
| Withdrew: Other reasons | 95 |
Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
| Participants | Nivolumab + Ipilimumab Total | Nivolumab + Ipilimumab ECOG PS0-1 | Nivolumab + Ipilimumab ECOG PS2 | Nivolumab + Ipilimumab Brain Metastasis | Nivolumab + Ipilimumab Mucosal | Nivolumab + Ipilimumab Ocular/Uveal | Nivolumab + Ipilimumab Cutaneous | Nivolumab + Ipilimumab Acral | Nivolumab + Ipilimumab Other |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary: Grade 3-4 | 7 | 7 | 0 | 0 | 0 | 1 | 6 | 0 | 0 |
| Pulmonary: Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal: Grade 3-4 | 83 | 79 | 4 | 5 | 5 | 9 | 57 | 1 | 11 |
| Gastrointestinal: Grade 5 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Skin: Grade 3-4 | 35 | 31 | 4 | 1 | 3 | 7 | 20 | 1 | 4 |
| Skin: Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Renal: Grade 3-4 | 10 | 9 | 1 | 1 | 0 | 1 | 8 | 0 | 1 |
| Renal: Grade 5 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Hepatic: Grade 3-4 | 82 | 75 | 7 | 6 | 2 | 17 | 56 | 1 | 6 |
| Hepatic: Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Endocrine: Grade 3-4 | 58 | 58 | 0 | 5 | 2 | 6 | 43 | 1 | 6 |
| Endocrine: Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypersensitivity/Infusion Reaction: Grade 3-4 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Hypersensitivity/Infusion Reaction: Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
| Participants | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary: Grade 3-4 | 8 | 8 | 0 | 0 | 0 | 1 | 7 | 0 | 0 |
| Gastrointestinal: Grade 3-4 | 87 | 83 | 4 | 5 | 5 | 9 | 61 | 1 | 11 |
| Gastrointestinal: Grade 5 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Skin: Grade 3-4 | 39 | 35 | 4 | 1 | 3 | 8 | 22 | 1 | 5 |
| Renal: Grade 3-4 | 13 | 12 | 1 | 1 | 0 | 1 | 10 | 1 | 1 |
| Renal: Grade 5 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Hepatic: Grade 3-4 | 101 | 93 | 8 | 11 | 4 | 21 | 67 | 1 | 8 |
| Hepatic: Grade 5 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Hypersensitivity/Infusion Reaction: Grade 3-4 | 2 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
| Days | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary | 51.5 (12 to 783) | 51.5 (12 to 783) | — | — | — | 51.0 (51 to 51) | 52.0 (12 to 783) | — | — |
| Gastrointestinal | 49.0 (7 to 582) | 49.0 (7 to 582) | 61.0 (8 to 91) | 83.0 (35 to 543) | 42.5 (27 to 543) | 39.0 (20 to 95) | 49.0 (7 to 582) | 7.0 (7 to 7) | 79.0 (8 to 281) |
| Skin | 32.0 (4 to 670) | 35.0 (4 to 404) | 17.5 (7 to 670) | 14.0 (14 to 14) | 48.0 (8 to 69) | 36.5 (14 to 127) | 17.5 (4 to 670) | 89.0 (89 to 89) | 100.0 (10 to 338) |
| Renal | 52.5 (6 to 540) | 43.0 (6 to 223) | 540.0 (540 to 540) | 106.0 (106 to 106) | — | 23.0 (23 to 23) | 106.0 (14 to 540) | 16.0 (16 to 16) | 6.0 (6 to 6) |
| Hepatic | 63.0 (5 to 724) | 63.0 (5 to 724) | 63.0 (13 to 83) | 64.0 (41 to 724) | 139.0 (22 to 475) | 64.0 (16 to 111) | 62.0 (5 to 588) | 101.0 (101 to 101) | 80.0 (8 to 724) |
| Endocrine | 75.0 (7 to 369) | 75.0 (7 to 369) | — | 67.0 (25 to 130) | 153.0 (102 to 204) | 70.0 (26 to 98) | 71.5 (7 to 369) | 114.0 (114 to 114) | 39.5 (16 to 115) |
| Hypersensitivity/Infusion Reaction | 291.5 (22 to 561) | 291.5 (22 to 561) | — | — | — | — | 22.0 (22 to 22) | — | 561.0 (561 to 561) |
Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
| Days | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary | 19.0 (5 to 64) | 19.0 (5 to 64) | — | — | — | 6.0 (6 to 6) | 30.0 (5 to 64) | — | — |
| Gastrointestinal | 22.0 (2 to 684) | 22.0 (2 to 684) | NA (8 to 437) | 107.5 (18 to 666) | 25.0 (6 to 437) | 14.0 (6 to 183) | 23.0 (2 to 684) | 5.0 (5 to 5) | 12.0 (4 to 214) |
| Skin | 24.0 (4 to 690) | 24.0 (4 to 690) | 20.0 (10 to 186) | 67.0 (67 to 67) | 8.0 (5 to 44) | 17.5 (4 to 690) | 24.0 (8 to 455) | 15.0 (15 to 15) | 28.0 (4 to 287) |
| Renal | 19.0 (3 to 66) | 23.0 (3 to 66) | 11.0 (11 to 11) | 7.0 (7 to 7) | — | 23.0 (23 to 23) | 11.0 (3 to 60) | NA (20 to 20) | 66.0 (66 to 66) |
| Hepatic | 42.0 (1 to 889) | 38.0 (1 to 889) | 67.0 (3 to 225) | 17.5 (2 to 285) | 126.0 (1 to 625) | 55.0 (1 to 612) | 30.0 (2 to 889) | 29.0 (29 to 29) | 117.0 (15 to 285) |
| Endocrine | NA (2 to 1223) | NA (3 to 1019) | — | NA (4 to 950) | NA (5 to 931) | NA (3 to 670) | NA (4 to 1019) | NA (514 to 514) | NA (4 to 627) |
| Hypersensitivity/Infusion Reaction | 4.5 (2 to 7) | 4.5 (2 to 7) | — | — | — | — | 2.0 (2 to 2) | — | 7.0 (7 to 7) |
Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
| Days | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary | 35.0 (6 to 738) | 43.0 (6 to 738) | 7.5 (7 to 8) | NA (55 to 302) | NA (7 to 371) | 19.0 (6 to 62) | 43.0 (7 to 738) | — | NA (24 to 302) |
| Gastrointestinal | 18.0 (1 to 1016) | 18.0 (1 to 1016) | 12.0 (1 to 468) | 36.0 (1 to 720) | 14.0 (1 to 527) | 14.0 (1 to 183) | 19.0 (1 to 1016) | 5.0 (1 to 22) | 36.0 (2 to 645) |
| Skin | 89.0 (1 to 1175) | 88.0 (1 to 1175) | NA (5 to 1002) | 257.0 (1 to 1011) | 84.0 (5 to 1055) | 33.5 (4 to 775) | 102.0 (1 to 1175) | 46.0 (15 to 625) | 59.5 (2 to 952) |
| Renal | 56.0 (2 to 904) | 56.0 (2 to 904) | 11.0 (11 to 11) | 5.5 (2 to 100) | 9.5 (4 to 15) | 27.5 (23 to 32) | 56.0 (2 to 904) | NA (20 to 20) | NA (66 to 603) |
| Hepatic | 44.0 (1 to 1008) | 43.0 (1 to 1008) | 80.5 (3 to 225) | 20.5 (3 to 1008) | 97.0 (1 to 650) | 34.0 (1 to 612) | 37.0 (3 to 912) | 129.0 (31 to 129) | 29.0 (8 to 1008) |
| Endocrine | NA (2 to 1223) | NA (2 to 1223) | NA (76 to 917) | NA (4 to 950) | NA (5 to 1139) | NA (2 to 759) | NA (4 to 1223) | NA (40 to 938) | NA (6 to 1060) |
| Hypersensitivity/Infusion Reaction | 1.0 (1 to 7) | 1.0 (1 to 7) | 1.0 (1 to 1) | — | — | — | 1.0 (1 to 7) | — | 1.0 (1 to 7) |
Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive
| Months | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Overall Survival (OS) | NA (33.91 to NA) | NA (34.76 to NA) | 11.01 (7.23 to NA) | NA (NA to NA) | 12.55 (3.78 to 33.91) | 15.21 (10.41 to 21.42) | NA (NA to NA) | 20.83 (1.15 to NA) | 34.76 (16.69 to NA) |
The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths
| Participants | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Adverse Events (AEs) | 533 | 477 | 55 | 42 | 32 | 64 | 365 | 10 | 62 |
| Treatment-Related AEs | 484 | 444 | 40 | 33 | 26 | 61 | 332 | 8 | 35 |
| Serious Adverse Events (SAEs) | 356 | 324 | 31 | 31 | 26 | 40 | 238 | 9 | 43 |
| Deaths | 199 | 169 | 29 | 13 | 20 | 41 | 107 | 6 | 25 |
The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
| Participants | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary | 28 | 26 | 2 | 2 | 2 | 3 | 21 | 0 | 2 |
| Gastrointestinal | 252 | 236 | 16 | 14 | 13 | 31 | 175 | 6 | 27 |
| Skin | 319 | 296 | 23 | 23 | 17 | 34 | 228 | 8 | 32 |
| Renal | 43 | 42 | 1 | 4 | 2 | 2 | 34 | 1 | 4 |
| Hepatic | 185 | 173 | 12 | 16 | 7 | 35 | 128 | 2 | 13 |
| Endocrine | 242 | 231 | 11 | 20 | 15 | 29 | 166 | 5 | 27 |
| Hypersensitivity/Infusion Reaction | 8 | 7 | 1 | 0 | 0 | 0 | 5 | 0 | 3 |
Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)
| Participants | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| ALT OR AST > 3XULN | 113 | 106 | 7 | 11 | 7 | 21 | 72 | 2 | 11 |
| ALT OR AST > 5XULN | 75 | 69 | 6 | 4 | 5 | 13 | 48 | 1 | 8 |
| ALT OR AST > 10XULN | 30 | 27 | 3 | 0 | 2 | 4 | 22 | 0 | 2 |
| ALT OR AST > 20XULN | 12 | 11 | 1 | 0 | 1 | 2 | 7 | 0 | 2 |
| TOTAL BILIRUBIN > 2XULN | 12 | 12 | 0 | 1 | 0 | 3 | 8 | 0 | 1 |
| CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 4 | 4 | 0 | 0 | 0 | 0 | 4 | 0 | 0 |
Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)
| Participants | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| TSH > ULN | 130 | 123 | 7 | 12 | 8 | 12 | 91 | 4 | 15 |
| TSH > ULN WITH TSH <= ULN AT BASELINE | 113 | 108 | 5 | 11 | 6 | 10 | 79 | 3 | 15 |
| TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 80 | 76 | 4 | 8 | 5 | 6 | 55 | 2 | 12 |
| TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 37 | 35 | 2 | 3 | 1 | 4 | 27 | 2 | 3 |
| TSH > ULN WITH FT3/FT4 TEST MISSING | 26 | 25 | 1 | 2 | 2 | 2 | 21 | 0 | 1 |
| TSH < LLN | 178 | 169 | 9 | 14 | 11 | 23 | 124 | 4 | 16 |
| TSH <LLN WITH TSH >= LLN AT BASELINE | 168 | 159 | 9 | 14 | 11 | 21 | 116 | 4 | 16 |
| TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 101 | 98 | 3 | 7 | 8 | 12 | 72 | 2 | 7 |
| TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 59 | 53 | 6 | 5 | 3 | 8 | 40 | 1 | 7 |
| TSH < LLN WITH FT3/FT4 TEST MISSING | 26 | 25 | 1 | 2 | 0 | 4 | 19 | 1 | 2 |
Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants
| Percentage of participants | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Objective Response Rate (ORR) | 44.5 (40.2 to 48.8) | 46.1 (41.6 to 50.7) | 30.9 (19.1 to 44.8) | 52.4 (36.4 to 68.0) | 43.8 (26.4 to 62.3) | 9.4 (3.5 to 19.3) | 51.2 (46.0 to 56.5) | 30.0 (6.7 to 65.2) | 43.5 (31.0 to 56.7) |
Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
| Months | Total | ECOG PS0-1 | ECOG PS2 | Brain Metastasis | Mucosal | Ocular/Uveal | Cutaneous | Acral | Other |
|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival (PFS) | 4.96 (3.45 to 6.77) | 5.45 (3.78 to 7.69) | 2.46 (1.77 to 3.75) | 3.35 (1.81 to NA) | 2.94 (2.53 to 8.74) | 2.83 (2.73 to 4.63) | 6.77 (4.67 to 10.45) | 2.56 (1.15 to 8.48) | 5.22 (2.76 to 27.27) |
Collected over From first dose to 30 days after last dose (up to approximately 37 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | 199/533 (37.3%) | 356/533 (66.8%) | 503/533 (94.4%) |
| Nivolumab + Ipilimumab ECOG PS0-1 | 169/477 (35.4%) | 324/477 (67.9%) | 453/477 (95%) |
| Nivolumab + Ipilimumab ECOG PS2 | 29/55 (52.7%) | 31/55 (56.4%) | 49/55 (89.1%) |
| Nivolumab + Ipilimumab Brain Metastasis | 13/42 (31%) | 31/42 (73.8%) | 37/42 (88.1%) |
| Nivolumab + Ipilimumab Mucosal | 20/32 (62.5%) | 26/32 (81.3%) | 28/32 (87.5%) |
| Nivolumab + Ipilimumab Ocular/Uveal | 41/64 (64.1%) | 40/64 (62.5%) | 61/64 (95.3%) |
| Nivolumab + Ipilimumab Cutaneous | 107/365 (29.3%) | 238/365 (65.2%) | 347/365 (95.1%) |
| Nivolumab + Ipilimumab Acral | 6/10 (60%) | 9/10 (90%) | 10/10 (100%) |
| Nivolumab + Ipilimumab Other | 25/62 (40.3%) | 43/62 (69.4%) | 57/62 (91.9%) |
| Event | Nivolumab + Ipilimumab Total | Nivolumab + Ipilimumab ECOG PS0-1 | Nivolumab + Ipilimumab ECOG PS2 | Nivolumab + Ipilimumab Brain Metastasis | Nivolumab + Ipilimumab Mucosal | Nivolumab + Ipilimumab Ocular/Uveal | Nivolumab + Ipilimumab Cutaneous | Nivolumab + Ipilimumab Acral | Nivolumab + Ipilimumab Other |
|---|---|---|---|---|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 71/533 | 57/477 | 14/55 | 13/42 | 8/32 | 9/64 | 42/365 | 2/10 | 10/62 |
| Adrenal insufficiencyEndocrine disorders | 6/533 | 6/477 | 0/55 | 0/42 | 0/32 | 0/64 | 4/365 | 1/10 | 1/62 |
| Autoimmune colitisGastrointestinal disorders | 12/533 | 11/477 | 1/55 | 1/42 | 1/32 | 1/64 | 6/365 | 1/10 | 3/62 |
| EnteritisGastrointestinal disorders | 3/533 | 3/477 | 0/55 | 0/42 | 0/32 | 0/64 | 2/365 | 1/10 | 0/62 |
| AstheniaGeneral disorders | 3/533 | 3/477 | 0/55 | 0/42 | 0/32 | 1/64 | 1/365 | 1/10 | 0/62 |
| EndocarditisInfections and infestations | 1/533 | 1/477 | 0/55 | 0/42 | 0/32 | 0/64 | 0/365 | 1/10 | 0/62 |
| Post procedural cellulitisInfections and infestations | 1/533 | 1/477 | 0/55 | 0/42 | 0/32 | 0/64 | 0/365 | 1/10 | 0/62 |
| PyodermaInfections and infestations | 1/533 | 1/477 | 0/55 | 0/42 | 0/32 | 0/64 | 0/365 | 1/10 | 0/62 |
| SepsisInfections and infestations | 6/533 | 5/477 | 1/55 | 1/42 | 0/32 | 0/64 | 5/365 | 1/10 | 0/62 |
| General physical condition abnormalInvestigations | 5/533 | 4/477 | 1/55 | 0/42 | 1/32 | 0/64 | 3/365 | 1/10 | 0/62 |
| Event | Nivolumab + Ipilimumab Total | Nivolumab + Ipilimumab ECOG PS0-1 | Nivolumab + Ipilimumab ECOG PS2 | Nivolumab + Ipilimumab Brain Metastasis | Nivolumab + Ipilimumab Mucosal | Nivolumab + Ipilimumab Ocular/Uveal | Nivolumab + Ipilimumab Cutaneous | Nivolumab + Ipilimumab Acral | Nivolumab + Ipilimumab Other |
|---|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 224/533 | 209/477 | 15/55 | 13/42 | 13/32 | 27/64 | 154/365 | 5/10 | 25/62 |
| NauseaGastrointestinal disorders | 156/533 | 144/477 | 11/55 | 10/42 | 8/32 | 24/64 | 105/365 | 5/10 | 14/62 |
| PruritusSkin and subcutaneous tissue disorders | 146/533 | 135/477 | 11/55 | 11/42 | 11/32 | 13/64 | 102/365 | 4/10 | 16/62 |
| FatigueGeneral disorders | 178/533 | 173/477 | 5/55 | 12/42 | 9/32 | 18/64 | 129/365 | 1/10 | 21/62 |
| PyrexiaGeneral disorders | 130/533 | 111/477 | 19/55 | 5/42 | 7/32 | 13/64 | 91/365 | 2/10 | 17/62 |
| Alanine aminotransferase increasedInvestigations | 101/533 | 91/477 | 10/55 | 9/42 | 4/32 | 20/64 | 69/365 | 1/10 | 7/62 |
| HeadacheNervous system disorders | 117/533 | 110/477 | 7/55 | 13/42 | 5/32 | 13/64 | 87/365 | 3/10 | 9/62 |
| AnaemiaBlood and lymphatic system disorders | 57/533 | 50/477 | 7/55 | 2/42 | 2/32 | 6/64 | 35/365 | 3/10 | 11/62 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 36/533 | 33/477 | 3/55 | 2/42 | 6/32 | 4/64 | 19/365 | 3/10 | 4/62 |
| RashSkin and subcutaneous tissue disorders | 82/533 | 76/477 | 6/55 | 5/42 | 4/32 | 7/64 | 59/365 | 3/10 | 9/62 |
| Age, Continuous(Years) | Nivolumab + Ipilimumab Total |
|---|---|
| Median | 59.0 ± 13.55 |
| Sex: Female, Male(Participants) | Nivolumab + Ipilimumab Total |
|---|---|
| Female | 217 |
| Male | 316 |
| Ethnicity (NIH/OMB)(Participants) | Nivolumab + Ipilimumab Total |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 515 |
| Unknown or Not Reported | 13 |
| Race (NIH/OMB)(Participants) | Nivolumab + Ipilimumab Total |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 521 |
| More than one race | 0 |
| Unknown or Not Reported | 10 |
Showing the first 100 of 111 sites across 12 countries.
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Bristol-Myers Squibb