NCT01621490 (PD-1) is a Phase 1 clinical trial of Nivolumab in Advanced Melanoma, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT01621490?

NCT01621490 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT01621490?

Interventions in NCT01621490: Nivolumab, Ipilimumab.

What condition does NCT01621490 study?

NCT01621490 studies Advanced Melanoma, Metastatic Melanoma.

Is NCT01621490 still recruiting?

NCT01621490 is currently completed. Last updated 23 April 2024.

Are results published for NCT01621490?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-04-23 · How we verify

NCT01621490: PD-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma

Completed Phase 1 Results posted Last updated 23 April 2024

What this trial tests

Phase 1 trial testing Nivolumab in Advanced Melanoma in 170 participants. Completed in 25 October 2018.

Timeline

27 September 2012

Primary endpoint
12 September 2017

25 October 2018

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	170
Start date	27 September 2012
Primary completion	12 September 2017
Estimated completion	25 October 2018
Sites	14 locations across Netherlands, United States, Spain

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
Ipilimumab — full drug profile →

Conditions studied

Advanced Melanoma — all drugs for Advanced Melanoma →
Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Advanced Melanoma or Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Change From Baseline to Week 7, of Interferon (IFN) and Interferon Gamma (IFN-gamma) Inducible Factors Primary · From last non-missing value prior to first dose to week 7 day 1

Baseline and post-treatment modulation of serum levels of chemokines, cytokines and other immune mediators were assessed by techniques that included ELISA or other multiplex-based assay methods. Primary analysis included IFN-gamma and IFN-gamma inducible factors, including chemokine \[C-X-C motif\] ligand 9 (CXCL9) and CXCL10

IFN-gamma Simoa

Group	Value	95% CI
N3 60M Naive	0.0130	± 0.1740
N3 60M PROG	0.0320	± 0.0817
N1 60M + I3 90M	0.2310	± 0.4528
N1 30M + I3 30M Non-BM	0.1600	± 1.2047
N3 30M Non-BM	0.0520	± 0.1207
N1 30M + I3 30M BM	0.0950	± 1.5082
N3 30M BM	0.0375	± 0.1868
N1+ I3 Non-BM	0.2200	± 0.8198
Naive Nivo Mono	0.0130	± 0.1674
All Nivo	0.0240	± 0.1373
All Combo	0.1520	± 1.0023
Total	0.0515	± 0.5944

CXL9 (aka MIG)

Group	Value	95% CI
N3 60M Naive	1105.0	± 10467.4
N3 60M PROG	1890.0	± 8706.0
N1 60M + I3 90M	4680.0	± 18096.9
N1 30M + I3 30M Non-BM	3542.0	± 12133.1
N3 30M Non-BM	-29.0	± 1684.2
N1 30M + I3 30M BM	5692.0	± 6796.0
N3 30M BM	3610.0	± 2197.4
N1+ I3 Non-BM	458.5	± 1651.0
Naive Nivo Mono	1056.5	± 9167.8
All Nivo	1235.0	± 8984.2
All Combo	4680.0	± 14792.5
Total	2027.0	± 11491.9

CXL10 (aka IP10)

Group	Value	95% CI
N3 60M Naive	184.0	± 514.1
N3 60M PROG	160.0	± 539.9
N1 60M + I3 90M	684.0	± 2563.1
N1 30M + I3 30M Non-BM	934.5	± 2842.0
N3 30M Non-BM	26.0	± 172.7
N1 30M + I3 30M BM	514.0	± 612.3
N3 30M BM	318.0	± 354.0
N1+ I3 Non-BM	695.0	± 2627.7
Naive Nivo Mono	185.0	± 474.6
All Nivo	184.0	± 500.7
All Combo	684.0	± 2450.6
Total	234.5	± 1566.3

Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay Primary · From last non-missing value prior to first dose to week 4 day 1

Biomarkers examined were percent positive CD8 and percent positive CD4, both using the Mosaic Singleplex IHC assay. Analyses are presented with the medians at baseline and on-treatment, rather than the median change because the baseline values differed across groups. Baseline was defined as the last non-missing value on or prior to the first dose of study therapy. Biopsies were also collected on treatment.

Percent CD8 Baseline

Group	Value	95% CI
N3 60M Naive	3.730	± 10.994
N3 60M PROG	7.230	± 10.712
N1 60M + I3 90M W2	3.260	± 9.259
N1 60M + I3 90M W4	11.105	± 9.524
N1 30M + I3 30M Non-BM	4.700	± 9.810
N3 30M Non-BM	5.615	± 12.475
N3 30M + I3 30M BM	18.590	± 8.132
N3 30M BM	6.135	± 5.664
Nivo Mono	6.360	± 10.727
Nivo Mono Reduced Infusion	5.615	± 11.472
Week 2 Biopsy Combo	4.700	± 9.292
Week 2 Biopsy Non-BM Combo	4.230	± 9.401

Percent positive CD8 Week 2

Group	Value	95% CI
N1 60M + I3 90M W2	11.345	± 21.316
N1 30M + I3 30M Non-BM	7.970	± 15.132
N3 30M Non-BM	10.100	± 10.909
N3 30M + I3 30M BM	8.470	± 7.740
N3 30M BM	29.735	± 5.254
Nivo Mono Reduced Infusion	10.910	± 12.387
Week 2 Biopsy Combo	9.080	± 17.510
Week 2 Biopsy Non-BM Combo	9.125	± 18.654
Naive Nivo Mono Non-BM	10.100	± 10.909
N1 + I3 Non-BM	9.125	± 18.654

Percent positive CD8 Week 4

Group	Value	95% CI
N3 60M Naive	18.435	± 17.108
N3 60M PROG	7.140	± 25.204
N1 60M + I3 90M W4	32.455	± 15.967
N1 30M + I3 30M Non-BM	37.465	± 5.706
Nivo Mono	15.150	± 21.475
Week 2 Biopsy Combo	37.465	± 5.706
Week 2 Biopsy Non-BM Combo	37.465	± 5.706
Naive Nivo Mono Non-BM	18.435	± 17.108
N1 + I3 Non-BM	34.785	± 13.856

Percent CD4 Baseline

Group	Value	95% CI
N3 60M Naive	0.360	± 1.844
N3 60M PROG	0.600	± 2.268
N1 60M + I3 90M W2	0.840	± 1.852
N1 60M + I3 90M W4	0.470	± 3.833
N1 30M + I3 30M Non-BM	4.155	± 6.624
N3 30M Non-BM	4.950	± 4.992
N3 30M + I3 30M BM	6.500	± 8.108
N3 30M BM	2.780	± NA
Nivo Mono	0.375	± 2.057
Nivo Mono Reduced Infusion	4.600	± 4.807
Week 2 Biopsy Combo	2.750	± 5.833
Week 2 Biopsy Non-BM Combo	2.610	± 5.607

Percent positive CD4 Week 2

Group	Value	95% CI
N1 60M + I3 90M W2	4.500	± 10.741
N1 30M + I3 30M Non-BM	6.260	± 8.518
N3 30M Non-BM	4.210	± 5.029
N3 30M + I3 30M BM	6.420	± 14.778
N3 30M BM	20.830	± NA
Nivo Mono Reduced Infusion	6.155	± 6.585
Week 2 Biopsy Combo	6.125	± 10.222
Week 2 Biopsy Non-BM Combo	5.990	± 9.602
Naive Nivo Mono Non-BM	4.210	± 5.029
N1 + I3 Non-BM	5.990	± 9.602

Percent positive CD4 Week 4

Group	Value	95% CI
N3 60M Naive	1.585	± 3.071
N3 60M PROG	1.260	± 4.641
N1 60M + I3 90M W4	9.005	± 13.324
N1 30M + I3 30M Non-BM	24.520	± 2.659
Nivo Mono	1.275	± 3.921
Week 2 Biopsy Combo	24.520	± 2.659
Week 2 Biopsy Non-BM Combo	24.520	± 2.659
Naive Nivo Mono Non-BM	1.585	± 3.071
N1 + I3 Non-BM	10.155	± 12.707

Frequency of Adverse Events or Death Secondary · Includes events reported between first dose and up to 100 days after last dose of study medication (up to approximately 73 months).

The assessment of safety was based on frequency of deaths and adverse events (AEs). AEs were graded for severity according to the NCI CTCAE version 4.0.

Participants who died

Group	Value	95% CI
N3 60M Naive	26
N3 60M PROG	25
N1 60M + I3 90M	11
N1 30M + I3 30M Non-BM	14
N3 30M Non-BM	4
N1 30M + I3 30M BM	2
N3 30M BM	4

Participants who died within 30 days of last dose

Group	Value	95% CI
N3 60M Naive	3
N3 60M PROG	2
N1 60M + I3 90M	4
N1 30M + I3 30M Non-BM	0
N3 30M Non-BM	0
N1 30M + I3 30M BM	1
N3 30M BM	0

Participants who died within 100 days of last dose

Group	Value	95% CI
N3 60M Naive	5
N3 60M PROG	8
N1 60M + I3 90M	5
N1 30M + I3 30M Non-BM	0
N3 30M Non-BM	1
N1 30M + I3 30M BM	2
N3 30M BM	2

Participants with an AE

Group	Value	95% CI
N3 60M Naive	41
N3 60M PROG	44
N1 60M + I3 90M	27
N1 30M + I3 30M Non-BM	25
N3 30M Non-BM	11
N1 30M + I3 30M BM	10
N3 30M BM	10

Frequency of AEs Leading to Discontinuation of Study Drug and SAEs Secondary · From enrollment to 100 days after the last dose date (up to approximately 73 months)

The assessment of safety was based on frequency of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of study drug. AEs were graded for severity according to the NCI CTCAE version 4.0.

SAEs

Group	Value	95% CI
N3 60M Naive	20
N3 60M Prog	22
N1 60M + I3 90M	20
N1 30M + I3 30M Non-BM	14
N3 30M Non-BM	2
N1 30M I3 30M BM	7
N3 30M BM	4

AEs Leading to Discontinuation

Group	Value	95% CI
N3 60M Naive	2
N3 60M Prog	6
N1 60M + I3 90M	12
N1 30M + I3 30M Non-BM	9
N3 30M Non-BM	1
N1 30M I3 30M BM	4
N3 30M BM	2

Number of Laboratory Abnormalities in Specific Liver Tests Secondary · 101-120 days after last dose.

Abnormalities in hepatic parameters measured included those in aspartate aminotransferase (AST), alanine aminotransferase (ALT)and total bilirubin, with respect to upper limit of normal (ULN)

ALT OR AST > 3XULN

Group	Value	95% CI
N3 60M NAIVE	2
N3 60M PROG	4
N1 60M +I3 90M	8
N1 30M + I3 30M Non-BM	5
N3 30M Non-BM	0
N1 30M + I3 30M BM	3
N3 30M BM	0

ALT OR AST> 5XULN

Group	Value	95% CI
N3 60M NAIVE	1
N3 60M PROG	2
N1 60M +I3 90M	6
N1 30M + I3 30M Non-BM	4
N3 30M Non-BM	0
N1 30M + I3 30M BM	1
N3 30M BM	0

ALT OR AST> 10XULN

Group	Value	95% CI
N3 60M NAIVE	1
N3 60M PROG	0
N1 60M +I3 90M	3
N1 30M + I3 30M Non-BM	2
N3 30M Non-BM	0
N1 30M + I3 30M BM	1
N3 30M BM	0

ALT OR AST > 20XULN

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M +I3 90M	1
N1 30M + I3 30M Non-BM	0
N3 30M Non-BM	0
N1 30M + I3 30M BM	1
N3 30M BM	0

TOTAL BILIRUBIN > 2XULN

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M +I3 90M	2
N1 30M + I3 30M Non-BM	1
N3 30M Non-BM	0
N1 30M + I3 30M BM	2
N3 30M BM	0

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M +I3 90M	2
N1 30M + I3 30M Non-BM	1
N3 30M Non-BM	0
N1 30M + I3 30M BM	1
N3 30M BM	0

ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAY

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M +I3 90M	2
N1 30M + I3 30M Non-BM	1
N3 30M Non-BM	0
N1 30M + I3 30M BM	1
N3 30M BM	0

Number of Laboratory Abnormalities in Specific Thyroid Tests Secondary · 101-120 days after last dose.

Abnormalities in thyroid parameters measured included those in thyroid stimulating hormone (TSH) levels with respect to upper limit of normal (ULN) and lower limit of normal (LLN)

TSH > ULN

Group	Value	95% CI
N3 60M NAIVE	9
N3 60M PROG	16
N1 60M +I3 90M	7
N1 30M + I3 30M Non-BM	7
N3 30M Non-BM	1
N1 30M + I3 30M BM	3
N3 30M BM	4

TSH > ULN WITH TSH <= ULN AT BASELINE

Group	Value	95% CI
N3 60M NAIVE	4
N3 60M PROG	9
N1 60M +I3 90M	7
N1 30M + I3 30M Non-BM	4
N3 30M Non-BM	1
N1 30M + I3 30M BM	3
N3 30M BM	2

TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M +I3 90M	3
N1 30M + I3 30M Non-BM	3
N3 30M Non-BM	0
N1 30M + I3 30M BM	2
N3 30M BM	2

TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M +I3 90M	0
N1 30M + I3 30M Non-BM	0
N3 30M Non-BM	0
N1 30M + I3 30M BM	0
N3 30M BM	0

TSH > ULN WITH FT3/FT4 TEST MISSING

Group	Value	95% CI
N3 60M NAIVE	9
N3 60M PROG	16
N1 60M +I3 90M	4
N1 30M + I3 30M Non-BM	4
N3 30M Non-BM	1
N1 30M + I3 30M BM	1
N3 30M BM	2

TSH < LLN

Group	Value	95% CI
N3 60M NAIVE	3
N3 60M PROG	4
N1 60M +I3 90M	11
N1 30M + I3 30M Non-BM	12
N3 30M Non-BM	2
N1 30M + I3 30M BM	6
N3 30M BM	5

TSH <LLN WITH TSH >= LLN AT BASELINE

Group	Value	95% CI
N3 60M NAIVE	3
N3 60M PROG	4
N1 60M +I3 90M	11
N1 30M + I3 30M Non-BM	12
N3 30M Non-BM	2
N1 30M + I3 30M BM	6
N3 30M BM	5

TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M +I3 90M	5
N1 30M + I3 30M Non-BM	4
N3 30M Non-BM	0
N1 30M + I3 30M BM	2
N3 30M BM	2

Objective Response Rate (ORR) Secondary · Approximately every 8 weeks until disease progression and in follow-up if no progression (up to approximately 73 months)

The objective response rate (ORR) was 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 randomized participants in the population of interest. The BOR was defined as the participant's best response designation, over the study as a whole, recorded between the date of first study drug administration and the date of objectively documented progression per RECIST 1.1, with subsequent confirmation, or date of subsequent anti-cancer therapy, whichever occurred first in the study.

Group	Value	95% CI
N3 60M Naive	31.7	18.1 – 48.1
N3 60M Prog	22.7	11.5 – 37.8
N1 60M+I3 90M	44.4	25.5 – 64.7
N1 30M + I3 30M Non-BM	40.0	21.1 – 61.3
N3 30M Non-BM	27.3	6.0 – 61.0
N1 30M + I3 30M BM	70.0	34.8 – 93.3
N3 30M BM	60.0	26.2 – 87.8

Median Duration of Response (mDOR) Secondary · From date of first documented objective response to date of disease progression or death, up to approximately 27 months

Median duration of response (mDOR) was calculated for subjects with BOR of CR or PR only, and is defined as time between the date of first documented objective response and the date of the first subsequent disease progression or death, whichever occurred first, if death occurred within 100 days after last dose of study medication.

Group	Value	95% CI
N3 60M Naive	16.59	7.29 – NA
N3 60M PROG	NA	5.55 – NA
N1 60M + I3 90M	NA	5.85 – NA
N1 30M + I3 30M NON-BM	26.25	7.85 – NA
N3 30M NON-BM	NA	3.71 – NA
N1 30M + I3 30M BM	NA	22.01 – NA
N3 30M BM	20.27	13.57 – NA

Median Time to Response (mTTR) Secondary · From the first dosing date to the date of the first documented objective response, up to approximately 15 months

Median time to response (mTTR) for a participant with a BOR of CR or PR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR).

Group	Value	95% CI
N3 60M Naive	1.87	1.77 – 3.71
N3 60M PROG	2.78	1.84 – 14.59
N1 60M + I3 90M	1.41	1.28 – 1.87
N1 30M + I3 30M NON-BM	2.51	1.28 – 2.86
N3 30M NON-BM	1.41	1.41 – 6.90
N1 30M + I3 30M BM	1.71	1.38 – 7.43
N3 30M BM	2.14	1.25 – 4.99

Progression Free Survival (PFS) Secondary · From first dose of study medication to the date of progression or death, whichever occurs first, up to approximately 29 months

Progression free survival (PFS) for a participant was defined as the time from the date of first dose of study medication to the date of the first documented disease progression, or death due to any cause, whichever occurred first, if death occurred within 100 days after last dose of study medication.

Group	Value	95% CI
N3 60M Naive	3.68	1.84 – 7.36
N3 60M PROG	5.62	1.87 – 9.66
N1 60M + I3 90M	7.00	1.41 – NA
N1 30M + I3 30M NON-BM	9.69	1.94 – 29.01
N3 30M NON-BM	4.93	1.41 – NA
N1 30M + I3 30M BM	NA	1.18 – NA
N3 30M BM	23.00	0.85 – NA

Immunogenicity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Number of Serum Anti-drug Antibody (ADA) Positive Participants and the Number of Neutralizing ADA Positive Participants Secondary · Up to follow-up visit 2 (101-120 days since last treatment)

Time Frame: Part 1: Day 1, Day 15, Day 43 of cycle 1, Day 1 of cycle 2, Day 15 of cycle 3, every 16 weeks after cycle 3 up to 2 years, follow-up visit 1 (40-60 days after last treatment), and follow-up visit 2 (101-120 days since last treatment) Part 2, 3 and 4: Weeks 1, 3, 4, 7, 9, 10, 13, 25, 53, 79, 95 follow-up visit 1 (40-60 days after last treatment), and follow-up visit 2 (101-120 days since last treatment)

ADA positive

Group	Value	95% CI
N3 60M NAIVE	2
N3 60M PROG	5
N1 60M + I3 (Nivo ADA	10
N1 60M + I3 90M (Ipi ADA)	1
N1 30M + I3 30M Non-BM (Nivo ADA)	16
N1 30M + I3 30M Non-BM (Ipi ADA)	4
N3 30M Non-BM	1
N1 30M + I3 30M (Nivo ADA)	7
N1 30M + I3 30M (Ipi ADA)	0
N3 30M BM	1
Total (Nivo ADA)	42
Total (Ipi ADA)	5

Neutralizing ADA positive

Group	Value	95% CI
N3 60M NAIVE	0
N3 60M PROG	0
N1 60M + I3 (Nivo ADA	0
N1 60M + I3 90M (Ipi ADA)	0
N1 30M + I3 30M Non-BM (Nivo ADA)	1
N1 30M + I3 30M Non-BM (Ipi ADA)	0
N3 30M Non-BM	0
N1 30M + I3 30M (Nivo ADA)	2
N3 30M BM	0
Total (Nivo ADA)	3
Total (Ipi ADA)	0

Objective Response Rate (ORR) by PD-L1 Expression Secondary · Approximately every 8 weeks until disease progression and in follow-up if no progression (up to approximately 73 months)

For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels \>= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. The association between PD-L1 expression status and/or level and clinical efficacy measur

STTU 1 - 1% Level PD-L1 Status: Met criteria

Group	Value	95% CI
N3 60M NAIVE, W4	40.0	19.1 – 63.9
N3 60M PROG, W4	35.3	14.2 – 61.7
N1 60M + I3 90M, W2	85.7	42.1 – 99.6
N1 60M + I3 90M, W4	50.0	11.8 – 88.2
N1 60M + I3 90M, WU	50.0	1.3 – 98.7
N1 30M + I3 30M NON-BM	63.6	30.8 – 89.1
N3 30M NON-BM, W2	40.0	5.3 – 85.3
N1 30M + I3 30M BM, W2	100.0	15.8 – 100.0
N3 30M BM, W2	100.0	2.5 – 100.0
N3 60M, W4	37.8	22.5 – 55.2
N3 30M, W2	50.0	11.8 – 88.2
N1 + I3, W2	75.0	50.9 – 91.3

STTU 1 - 5% Level PD-L1 Status: Met criteria

Group	Value	95% CI
N3 60M NAIVE, W4	40.0	12.2 – 73.8
N3 60M PROG, W4	33.3	7.5 – 70.1
N1 60M + I3 90M, W2	80.0	28.4 – 99.5
N1 60M + I3 90M, W4	60.0	14.7 – 94.7
N1 60M + I3 90M, WU	100.0	2.5 – 100.0
N1 30M + I3 30M NON-BM	71.4	29.0 – 96.3
N3 30M NON-BM, W2	50.0	1.3 – 98.7
N1 30M + I3 30M BM, W2	100.0	15.8 – 100.0
N3 30M BM, W2	100.0	2.5 – 100.0
N3 60M, W4	36.8	16.3 – 61.6
N3 30M, W2	66.7	9.4 – 99.2
N1 + I3, W2	78.6	49.2 – 95.3

STTU 1 - 10% Level PD-L1 Status: Met criteria

Group	Value	95% CI
N3 60M NAIVE, W4	42.9	9.9 – 81.6
N3 60M PROG, W4	20.0	0.5 – 71.6
N1 60M + I3 90M, W2	100.0	29.2 – 100.0
N1 60M + I3 90M, W4	75.0	19.4 – 99.4
N1 60M + I3 90M, WU	100.0	2.5 – 100.0
N1 30M + I3 30M NON-BM	66.7	9.4 – 99.2
N3 30M NON-BM, W2	100.0	2.5 – 100.0
N1 30M + I3 30M BM, W2	100.0	15.8 – 100.0
N3 30M BM, W2	100.0	2.5 – 100.0
N3 60M, W4	33.3	9.9 – 65.1
N3 30M, W2	100.0	15.8 – 100.0
N1 + I3, W2	87.5	47.3 – 99.7

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

N3 60M NAIVE

Serious: 20/41 (49%)

Deaths: 26/41

N3 60M PROG

Serious: 22/44 (50%)

Deaths: 25/44

N1 60M + I3 90M, W2

Serious: 8/11 (73%)

Deaths: 4/11

N1 60M + I3 90M, W4

Serious: 6/10 (60%)

Deaths: 3/10

N1 60M + I3 90M, WU

Serious: 6/6 (100%)

Deaths: 4/6

N1 30M + I3 30M Non-BM

Serious: 14/25 (56%)

Deaths: 14/25

N3 30M Non-BM

Serious: 2/11 (18%)

Deaths: 4/11

I3 Monotherapy

Serious: 1/1 (100%)

Deaths: 1/1

N1 30M + I3 30M BM

Serious: 7/10 (70%)

Deaths: 2/10

N3 30M BM

Serious: 4/10 (40%)

Deaths: 4/10

Unplanned Treatment

Serious: 1/1 (100%)

Deaths: 1/1

Serious adverse events (103 terms)

Reaction	System	N3 60M NAIVE	N3 60M PROG	N1 60M + I3 90M, W2	N1 60M + I3 90M, W4	N1 60M + I3 90M, WU	N1 30M + I3 30M Non-BM	N3 30M Non-BM	I3 Monotherapy	N1 30M + I3 30M BM	N3 30M BM	Unplanned Treatment
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—
Hyperthyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—
Hypophysitis	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—
Iridocyclitis	Eye disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Autoimmune colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Enterocolitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Intestinal ischaemia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Intra-abdominal fluid collection	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (277 terms — click to expand)

Reaction	System	N3 60M NAIVE	N3 60M PROG	N1 60M + I3 90M, W2	N1 60M + I3 90M, W4	N1 60M + I3 90M, WU	N1 30M + I3 30M Non-BM	N3 30M Non-BM	I3 Monotherapy	N1 30M + I3 30M BM	N3 30M BM	Unplanned Treatment
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Vitiligo	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—
Hyperthyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Colitis, Pyrexia, Diarrhoea, Alanine aminotransferase increased, Dehydration, Anaemia, Autoimmune haemolytic anaemia.

Data from ClinicalTrials.gov NCT01621490 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Tumor and Microenvironment Evolution during Immunotherapy with Nivolumab.
Riaz N, Havel JJ, Makarov V, Desrichard A, et al · · 2017 · cited 1872× · PMID 29033130 · DOI 10.1016/j.cell.2017.09.028
The Challenges of Tumor Mutational Burden as an Immunotherapy Biomarker.
Jardim DL, Goodman A, de Melo Gagliato D, Kurzrock R. · · 2021 · cited 935× · PMID 33125859 · DOI 10.1016/j.ccell.2020.10.001
The Next Immune-Checkpoint Inhibitors: PD-1/PD-L1 Blockade in Melanoma.
Mahoney KM, Freeman GJ, McDermott DF. · · 2015 · cited 440× · PMID 25823918 · DOI 10.1016/j.clinthera.2015.02.018
Efficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis.
D'Angelo SP, Larkin J, Sosman JA, Lebbé C, et al · · 2017 · cited 439× · PMID 28056206 · DOI 10.1200/jco.2016.67.9258
Elevated serum interleukin-8 is associated with enhanced intratumor neutrophils and reduced clinical benefit of immune-checkpoint inhibitors.
Schalper KA, Carleton M, Zhou M, Chen T, et al · · 2020 · cited 429× · PMID 32405062 · DOI 10.1038/s41591-020-0856-x
Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer.
Sznol M, Chen L. · · 2013 · cited 418× · PMID 23460533 · DOI 10.1158/1078-0432.ccr-12-2063
Gut microbiota signatures are associated with toxicity to combined CTLA-4 and PD-1 blockade.
Andrews MC, Duong CPM, Gopalakrishnan V, Iebba V, et al · · 2021 · cited 344× · PMID 34239137 · DOI 10.1038/s41591-021-01406-6
Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting

Other recruiting trials for Advanced Melanoma

Currently open trials in the same condition.

NCT07310784 — A Phase II Trial of LM103 in Advanced Melanoma · Phase 2 · recruiting
NCT07099430 — A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma · Phase 1, PHASE2 · recruiting
NCT05629546 — Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on C · Phase 1 · recruiting
NCT06264180 — VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] · Phase 3 · recruiting
NCT06298734 — High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial · NA · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01621490 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 23 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01621490.

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