Phase 3 Study of Nivolumab or Nivolumab plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma

A Phase 3, Randomized, Double- Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma Pharmacogenetics Blood Sample Protocol Amendment 01, version 1.0, dated 19-Mar-2013

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005371-13-AT

Enrollment

1144

Registered

2013-05-10

Start date

2013-07-05

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

Unresectable or metastatic melanoma MedDRA version: 21.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histologically confirmed stage III (unresectable) or stage IV melanoma • Treatment naïve patients • Measurable disease by CT or MRI per RECIST 1.1 criteria. • Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses. • ECOG PS 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 795 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 349

Exclusion criteria

Exclusion criteria: • Active brain metastases or leptomeningeal metastases • Ocular melanoma • Subjects with active, known or suspected autoimmune disease • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.;Secondary Objective: • ORR • Differences in OS, PFS and ORR between experimental arms • PFS and OS based on PD-L1 expression • Mean changes from baseline in EORTC-QLQ-C30;Primary end point(s): -Endpoint of Overall Survival (OS) in all randomized subjects -Progression Free Survival (PFS) ;Timepoint(s) of evaluation of this end point: OS: From the beginning of randomization period up to date of event (expected to be no more than 5 years) PFS : Time Frame: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years)]	—

Measure

Time frame

Main Objective: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.;Secondary Objective: • ORR • Differences in OS, PFS and ORR between experimental arms • PFS and OS based on PD-L1 expression • Mean changes from baseline in EORTC-QLQ-C30;Primary end point(s): -Endpoint of Overall Survival (OS) in all randomized subjects -Progression Free Survival (PFS) ;Timepoint(s) of evaluation of this end point: OS: From the beginning of randomization period up to date of event (expected to be no more than 5 years) PFS : Time Frame: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years)]

—

Secondary

Measure	Time frame
Secondary end point(s): • ORR • Differences in OS, PFS and ORR between experimental arms • PFS and OS based on PD-L1 expression • Mean changes from baseline in EORTC-QLQ-C30;Timepoint(s) of evaluation of this end point: • ORR: Baseline, Week 12 every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years) • OS, PFS, and ORR at the same time points identified for the primary and first secondary objectives • PFS and OS at the same time points identified as the primary objective and PD-L1 expression at Baseline: • Baseline, every 4 weeks for 6 months, then every 6 weeks until disease progression is documented, during follow-up (30 days after last dose, 100-114 days after last dose)	—

Measure

Time frame

Secondary end point(s): • ORR • Differences in OS, PFS and ORR between experimental arms • PFS and OS based on PD-L1 expression • Mean changes from baseline in EORTC-QLQ-C30;Timepoint(s) of evaluation of this end point: • ORR: Baseline, Week 12 every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years) • OS, PFS, and ORR at the same time points identified for the primary and first secondary objectives • PFS and OS at the same time points identified as the primary objective and PD-L1 expression at Baseline: • Baseline, every 4 weeks for 6 months, then every 6 weeks until disease progression is documented, during follow-up (30 days after last dose, 100-114 days after last dose)

—

Countries

Australia, Austria, Belgium, Brazil, Canada, Czechia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026