A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
CompletedPhase 3Results postedLast updated 19 April 2022
What this trial tests
Phase 3 trial testing BMS-936558 in Unresectable or Metastatic Melanoma in 405 participants. Completed in 29 December 2020.
18 and older, any sex, with Unresectable 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.
Objective Response Rate (ORR)Primary· From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
Group
Value
95% CI
Nivolumab
27.2
22.0 – 32.9
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
9.8
5.3 – 16.1
Overall Survival (OS)Primary· Up to 96 months
Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
Group
Value
95% CI
Nivolumab
15.74
12.88 – 19.88
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
14.39
11.66 – 18.17
Progression Free Survival (PFS)Secondary· From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
Group
Value
95% CI
Nivolumab
3.12
2.33 – 3.52
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
3.65
2.30 – 5.29
Objective Response Rate (ORR) by Baseline PD-L1 ExpressionSecondary· From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
<5% PD-L1 expression
Group
Value
95% CI
Nivolumab
15.3
9.7 – 22.5
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
13.8
6.1 – 25.4
>=5% PD-L1 expression
Group
Value
95% CI
Nivolumab
43.2
33.9 – 53.0
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
12.2
4.1 – 26.2
Overall Survival (OS) by PD-L1 PositiveSecondary· Up to 96 months
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Group
Value
95% CI
Nivolumab
31.44
20.57 – 46.69
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
16.72
11.83 – 31.44
Overall Survival (OS) by PD-L1 NegativeSecondary· Up to 96 months
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Group
Value
95% CI
Nivolumab
11.14
7.72 – 13.21
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
11.76
8.05 – 17.81
Mean Change From Baseline in Health-related Quality of Life (HRQoL)Secondary· From Baseline (Day1) to second Follow-Up (Up to 96 months)
Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.
Higher scores for all functional scales and Global Health Status
Physical Functioning Follow-Up 1
Group
Value
95% CI
Nivolumab
-7.97
± 20.49
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-12.73
± 21.47
Physical Functioning Follow-Up 2
Group
Value
95% CI
Nivolumab
-3.66
± 16.05
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-7.14
± 16.02
Role Functioning Follow-Up 1
Group
Value
95% CI
Nivolumab
-14.94
± 31.13
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-15.91
± 29.76
Role Functioning Follow-Up 2
Group
Value
95% CI
Nivolumab
-7.80
± 25.56
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-8.33
± 21.52
Emotional Functioning Follow-Up 1
Group
Value
95% CI
Nivolumab
-5.09
± 21.59
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-15.48
± 24.48
Emotional Functioning Follow-Up 2
Group
Value
95% CI
Nivolumab
-0.94
± 19.15
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-5.36
± 25.98
Cognitive Functioning Follow-Up 1
Group
Value
95% CI
Nivolumab
-7.58
± 16.79
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-7.94
± 17.17
Cognitive Functioning Follow-Up 2
Group
Value
95% CI
Nivolumab
-3.49
± 15.43
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
-1.19
± 13.55
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose to 100 days post last dose (Up to 96 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab
Serious: 191/268 (71%)
Deaths: 206/268
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Serious: 37/102 (36%)
Deaths: 88/102
Serious adverse events (193 terms)
Reaction
System
Nivolumab
Investigator's Choice (Dac…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pneumonia
Infections and infestations
—
—
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
General physical health deterioration
General disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Sepsis
Infections and infestations
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Cardiac arrest
Cardiac disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04648319 — A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma
· Phase 2
· terminated
NCT02061761 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
· Phase 1, PHASE2
· completed
NCT01176461 — Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558
· Phase 1
· completed
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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: 19 April 2022
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/NCT01721746.