An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223779

Enrollment

700

Registered

2018-01-18

Start date

2018-03-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Interventions

investigational material(s) Generic name etc : BMS-986205 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males and Females, ages 18 years or older Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition) Treatment-naive participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma) Measurable disease per RECIST v1.1

Exclusion criteria

Exclusion criteria: Active brain metastases or leptomeningeal metastases Uveal or ocular melanoma Participants with active, known, or suspected autoimmune disease Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

Design outcomes

Primary

Measure	Time frame
safety Progression Free Survival (PFS)	—

Secondary

Measure	Time frame
safety efficacy Overall Response Rate (ORR) Overall Survival (OS) The overall safety and tolerability	—

Countries

Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026