NCT01358721

Phase I Biomarker Study (BMS-936558)

Completed Phase 1 Results posted Last updated 28 October 2021

What this trial tests

Phase 1 trial testing BMS-936558 (Anti-PD-1) in Renal Cell Carcinoma in 119 participants. Completed in 22 May 2019.

Timeline

23 September 2011

Primary endpoint
1 December 2014

22 May 2019

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	119
Start date	23 September 2011
Primary completion	1 December 2014
Estimated completion	22 May 2019
Sites	14 locations across France, United States, Spain

Drugs / interventions tested

• BMS-936558 (Anti-PD-1) — full drug profile →
• BMS-936558 (Anti-PD-1) — full drug profile →
• BMS-936558 (Anti-PD-1) — full drug profile →

Conditions studied

• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Renal Cell Carcinoma. 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.

Percent Change From Baseline in Activated and Memory T Cells Primary · Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 8, Cycle 4 Day 1

The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody in activated and memory T cells with metastatic clear-cell Renal Cell Carcinoma (RCC)

Cycle 1 Day 1

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 2 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Treatment-naive)	NA	NA – NA

Cycle 1 Day 2

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 2 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Treatment-naive)	NA	NA – NA

Cycle 1 Day 8

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 2 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Treatment-naive)	NA	NA – NA

Cycle 2 Day 8

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 2 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Treatment-naive)	NA	NA – NA

Cycle 4 Day 1

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 2 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Treatment-naive)	NA	NA – NA

Mean Serum Cytokines: CXCL9 Primary · Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months)

Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10)

Cycle 1 Day 1, 3 HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	2859.1	± 2481.44
Nivolumab 2 mg/kg (Previously-treated)	2294.3	± 1528.97
Nivolumab 10 mg/kg (Previously-treated)	1906.6	± 1744.09
Nivolumab 10 mg/kg (Treatment-naive)	2203.6	± 1728.76

Cycle 1 Day 1, 7HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	3287.7	± 3617.32
Nivolumab 2 mg/kg (Previously-treated)	2567.1	± 1885.13
Nivolumab 10 mg/kg (Previously-treated)	2546.1	± 2421.00
Nivolumab 10 mg/kg (Treatment-naive)	2883.6	± 2827.77

Cycle 1 Day 2, 24 HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	5447.3	± 7006.73
Nivolumab 2 mg/kg (Previously-treated)	4332.3	± 3875.12
Nivolumab 10 mg/kg (Previously-treated)	4216.4	± 4715.61
Nivolumab 10 mg/kg (Treatment-naive)	3858.80	± 2841.7

Cycle 2 Day 1, 0 HRSPRE

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	5192.6	± 4447.78
Nivolumab 2 mg/kg (Previously-treated)	7220.6	± 9385.90
Nivolumab 10 mg/kg (Previously-treated)	5398.8	± 5428.64
Nivolumab 10 mg/kg (Treatment-naive)	5687.4	± 6788.78

Cycle 2 Day 8, 168 HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	5271.5	± 5196.91
Nivolumab 2 mg/kg (Previously-treated)	4932.6	± 4321.91
Nivolumab 10 mg/kg (Previously-treated)	5751.3	± 5900.87
Nivolumab 10 mg/kg (Treatment-naive)	5773.2	± 6560.9

Cycle 4 Day 1, 0 HRSPRE

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	8519.4	± 11444.72
Nivolumab 2 mg/kg (Previously-treated)	5131.2	± 4330.84
Nivolumab 10 mg/kg (Previously-treated)	3523.6	± 2678.32
Nivolumab 10 mg/kg (Treatment-naive)	5449.5	± 4021.84

BASELINE

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	2681.6	± 2135.89
Nivolumab 2 mg/kg (Previously-treated)	2213.5	± 1520.44
Nivolumab 10 mg/kg (Previously-treated)	2065.3	± 1805.25
Nivolumab 10 mg/kg (Treatment-naive)	2610.6	± 2118.11

Mean Serum Cytokines CXCL10 (IP10) Primary · Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months)

Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10)

Cycle 1 Day 1, 3 HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	525.5	± 335.10
Nivolumab 2 mg/kg (Previously-treated)	523.4	± 400.88
Nivolumab 10 mg/kg (Previously-treated)	422.0	± 264.54
Nivolumab 10 mg/kg (Treatment-naive)	450.7	± 247.78

Cycle 1 Day 1, 7HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	591.4	± 360.30
Nivolumab 2 mg/kg (Previously-treated)	727.7	± 626.98
Nivolumab 10 mg/kg (Previously-treated)	762.2	± 896.22
Nivolumab 10 mg/kg (Treatment-naive)	531.4	± 508.20

Cycle 1 Day 2, 24 HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	813.2	± 547.71
Nivolumab 2 mg/kg (Previously-treated)	758.8	± 616.06
Nivolumab 10 mg/kg (Previously-treated)	736.1	± 787.53
Nivolumab 10 mg/kg (Treatment-naive)	700.5	± 738.71

Cycle 2 Day 1, 0 HRSPRE

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	718.0	± 471.22
Nivolumab 2 mg/kg (Previously-treated)	835.9	± 579.07
Nivolumab 10 mg/kg (Previously-treated)	781.9	± 753.41
Nivolumab 10 mg/kg (Treatment-naive)	679.4	± 556.47

Cycle 2 Day 8, 168 HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	724.1	± 470.03
Nivolumab 2 mg/kg (Previously-treated)	677.6	± 341.15
Nivolumab 10 mg/kg (Previously-treated)	794.6	± 882.64
Nivolumab 10 mg/kg (Treatment-naive)	770.6	± 672.43

Cycle 4 Day 1, 0 HRSPRE

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	1272.8	± 2075.49
Nivolumab 2 mg/kg (Previously-treated)	678.7	± 364.85
Nivolumab 10 mg/kg (Previously-treated)	431.3	± 133.78
Nivolumab 10 mg/kg (Treatment-naive)	794.8	± 574.14

BASELINE

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	474.5	± 236.75
Nivolumab 2 mg/kg (Previously-treated)	483.0	± 383.77
Nivolumab 10 mg/kg (Previously-treated)	397.4	± 223.89
Nivolumab 10 mg/kg (Treatment-naive)	767.9	± 525.06

Mean CD4 T Cell Infiltration Primary · Cycle 2 Day 8 168 Hr post dose

The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD4 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC).

Baseline

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	34.1	± 78.40
Nivolumab 2 mg/kg (Previously-treated)	10.4	± 34.38
Nivolumab 10 mg/kg (Previously-treated)	35.2	± 77.44
Nivolumab 10 mg/kg (Treatment-naive)	53.2	± 109.31

Cycle 2 Day 8, 168 HrsPost

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	64.8	± 77.22
Nivolumab 2 mg/kg (Previously-treated)	28.2	± 46.93
Nivolumab 10 mg/kg (Previously-treated)	53.4	± 97.98
Nivolumab 10 mg/kg (Treatment-naive)	107.4	± 254.75

Mean CD8 T Cell Infiltration Primary · 168 hour post does Cycle 2 Day 8 in evaluable participates (First active dose of study medication to cycle two day eight post injection)

The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD8 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC).

Baseline

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	10.2	± 13.77
Nivolumab 2 mg/kg (Previously-treated)	7.8	± 10.62
Nivolumab 10 mg/kg (Previously-treated)	11.9	± 14.31
Nivolumab 10 mg/kg (Treatment-naive)	14.4	± 18.37

Cycle 2 Day 8, 169 HRSPOST

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	14.9	± 13.85
Nivolumab 2 mg/kg (Previously-treated)	18.9	± 17.07
Nivolumab 10 mg/kg (Previously-treated)	23.3	± 23.49
Nivolumab 10 mg/kg (Treatment-naive)	16.3	± 22.19

Best Overall Response in the BMS-936558 Arms Secondary · Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (up to approximately 39 months)

Baseline and post-nivolumab treatment modulation of serum levels of interferon-gamma stimulated chemokines CXCL9 and CXCL10 (IP10) were assessed. 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 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Ov

Complete Response

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	0
Nivolumab 2 mg/kg (Previously-treated)	0
Nivolumab 10 mg/kg (Previously-treated)	0
Nivolumab 10 mg/kg (Treatment-naive)	2

Partial Response

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	2
Nivolumab 2 mg/kg (Previously-treated)	4
Nivolumab 10 mg/kg (Previously-treated)	5
Nivolumab 10 mg/kg (Treatment-naive)	1

Stable Disease

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	8
Nivolumab 2 mg/kg (Previously-treated)	10
Nivolumab 10 mg/kg (Previously-treated)	11
Nivolumab 10 mg/kg (Treatment-naive)	13

Progressive Disease

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	9
Nivolumab 2 mg/kg (Previously-treated)	5
Nivolumab 10 mg/kg (Previously-treated)	6
Nivolumab 10 mg/kg (Treatment-naive)	7

Unable To Determine

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	2
Nivolumab 2 mg/kg (Previously-treated)	3
Nivolumab 10 mg/kg (Previously-treated)	0
Nivolumab 10 mg/kg (Treatment-naive)	0

Progression Free Survival Rate in BMS-936558 Secondary · Progression free survival rate will be assessed in each individual treatment arm by tumor assessments at 16, 24, and 48 weeks. From initial dose to end of study (assessed up to 39 months)

PFS is defined as the time from treatment arm assignment to the date of first documented disease progression. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have any on study tumor assessments will be censored on the date they were assigned a treatment arm. PFS rate is the percentage of participants who did not have disease progression at particular time points (16 weeks, 24 weeks, 48 weeks)

16 weeks

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	0.29	0.12 – 0.48
Nivolumab 2 mg/kg (Previously-treated)	0.49	0.27 – 0.68
Nivolumab 10 mg/kg (Previously-treated)	0.63	0.39 – 0.79
Nivolumab 10 mg/kg (Treatment-naive)	0.55	0.32 – 0.72

24 weeks

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	0	0 – 0
Nivolumab 2 mg/kg (Previously-treated)	0.44	0.23 – 0.63
Nivolumab 10 mg/kg (Previously-treated)	0.58	0.35 – 0.76
Nivolumab 10 mg/kg (Treatment-naive)	0.50	0.28 – 0.68

48 weeks

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	0	0 – 0
Nivolumab 2 mg/kg (Previously-treated)	0	0 – 0
Nivolumab 10 mg/kg (Previously-treated)	0.32	0.13 – 0.52
Nivolumab 10 mg/kg (Treatment-naive)	0.39	0.18 – 0.59

Objective Response Rate in BMS-936558 Secondary · Up to 22 months after study start

The total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of participants in the population of interest, and expressed as a percentage.

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	9.1	1.1 – 29.2
Nivolumab 2 mg/kg (Previously-treated)	18.2	5.2 – 40.3
Nivolumab 10 mg/kg (Previously-treated)	21.7	7.5 – 43.7
Nivolumab 10 mg/kg (Treatment-naive)	12.5	2.7 – 32.4

Duration of Objective Response for BMS-936558 Secondary · The time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death (assessed up to 39 months)

The duration of response is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. For subjects who neither progress nor die, the duration of response will be censored at the date of their last tumor assessment.

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	30	24.1 – 35.9
Nivolumab 2 mg/kg (Previously-treated)	NA	NA – NA
Nivolumab 10 mg/kg (Previously-treated)	48.1	12.0 – NA
Nivolumab 10 mg/kg (Treatment-naive)	NA	NA – NA

Duration of Stable Disease for BMS-936558 as Measured in Participants Whose Best Overall Response is Stable Disease as the Time From Baseline Until the Date of Documented Disease Progression or Death Secondary · The time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first)(assessed up to 39 months)

Duration of stable disease (SD) is defined in participants whose BOR is SD at the time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first). Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	16.5	11.6 – 36.3
Nivolumab 2 mg/kg (Previously-treated)	31.4	10.7 – NA
Nivolumab 10 mg/kg (Previously-treated)	41.3	12.1 – 75.6
Nivolumab 10 mg/kg (Treatment-naive)	35.1	12.3 – 53.4

Immunogenicity of BMS-936558 as Measured by the Detection of Human Antibodies Against BMS-936558 Secondary · Pre-dose, Cycle 4 Day 1, Cycle 8 Day 1 and during follow-up.

Blood samples to evaluate the development of a positive anti-drug antibodies (ADA) response at the doses tested will be collected at time-points pre-dose, C4D1, C8D1 and during follow-up.

Anti-Drug Antibody (ADA) positive (%)

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	11.8
Nivolumab 2 mg/kg (Previously-treated)	15.8
Nivolumab 10 mg/kg (Previously-treated)	13.6
Nivolumab 10 mg/kg (Treatment-naive)	0

Anti-Drug Antibody (ADA) negative(%)

Group	Value	95% CI
Nivolumab 0.3 mg/kg (Previously-treated)	88.2
Nivolumab 2 mg/kg (Previously-treated)	84.2
Nivolumab 10 mg/kg (Previously-treated)	86.4
Nivolumab 10 mg/kg (Treatment-naive)	100

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose to within 100 days of last dose. (10/2011 - 01/2015). From First dose up to 100 days after last dose of study drug, assessed up to January 2017 (approximately 39 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BMS 0.3 mg/kg

Serious: 13/22 (59%)

Deaths: —

BMS 2 mg/kg

Serious: 11/22 (50%)

Deaths: —

BMS 10 mg/kg

Serious: 12/23 (52%)

Deaths: —

BMS 10 mg/Kg-N

Serious: 13/24 (54%)

Deaths: —

Serious adverse events (66 terms)

Reaction	System	BMS 0.3 mg/kg	BMS 2 mg/kg	BMS 10 mg/kg	BMS 10 mg/Kg-N
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Atrial flutter	Cardiac disorders	—	—	—	—
Papilloedema	Eye disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—	—
Small intestinal haemorrhage	Gastrointestinal disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Sudden death	General disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—
Fracture	Injury, poisoning and procedural complications	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—

Other adverse events (84 terms — click to expand)

Reaction	System	BMS 0.3 mg/kg	BMS 2 mg/kg	BMS 10 mg/kg	BMS 10 mg/Kg-N
Fatigue	General disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Weight decreased	Investigations	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Acute kidney injury, Dyspnoea, Atrial flutter, Papilloedema.

Data from ClinicalTrials.gov NCT01358721 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

Publications & conference data

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

1. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.
   Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, et al · · 2012 · cited 9851× · PMID 22658127 · DOI 10.1056/nejmoa1200690
2. PD-1 and PD-L1 Checkpoint Signaling Inhibition for Cancer Immunotherapy: Mechanism, Combinations, and Clinical Outcome.
   Alsaab HO, Sau S, Alzhrani R, Tatiparti K, et al · · 2017 · cited 1206× · PMID 28878676 · DOI 10.3389/fphar.2017.00561
3. Interplay of somatic alterations and immune infiltration modulates response to PD-1 blockade in advanced clear cell renal cell carcinoma.
   Braun DA, Hou Y, Bakouny Z, Ficial M, et al · · 2020 · cited 771× · PMID 32472114 · DOI 10.1038/s41591-020-0839-y
4. 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
5. Single-cell sequencing links multiregional immune landscapes and tissue-resident T cells in ccRCC to tumor topology and therapy efficacy.
   Krishna C, DiNatale RG, Kuo F, Srivastava RM, et al · · 2021 · cited 327× · PMID 33861994 · DOI 10.1016/j.ccell.2021.03.007
6. Breathing new life into immunotherapy: review of melanoma, lung and kidney cancer.
   Drake CG, Lipson EJ, Brahmer JR. · · 2014 · cited 313× · PMID 24247168 · DOI 10.1038/nrclinonc.2013.208
7. Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma.
   Choueiri TK, Fishman MN, Escudier B, McDermott DF, et al · · 2016 · cited 236× · PMID 27169994 · DOI 10.1158/1078-0432.ccr-15-2839
8. Antagonists of PD-1 and PD-L1 in Cancer Treatment.
   Lipson EJ, Forde PM, Hammers HJ, Emens LA, et al · · 2015 · cited 236× · PMID 26320063 · DOI 10.1053/j.seminoncol.2015.05.013