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EUCTR2012-005371-13
Alternative entry: NCT01844505

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

Data source: WHO (Imported from 02.08.2020)
Changed: 02.08.2020
Disease category:

Health conditions (Data source: WHO)

Unresectable or metastatic melanoma
MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864;Therapeutic area: Diseases [C] - Cancer [C04]

Interventions (Data source: WHO)


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: 946414-94-4
Current Sponsor code: BMS-936558-01
Other descriptive name: BMS936558
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Product Name: Ipilimumab
Product Code: BMS-734016
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPILIMUMAB
CAS Number: 477202-00-9
Current Sponsor code: BMS-734016 / MDX010
Other descriptive name: BMS734016
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Trade Name: Opdivo (100 mg/10 ml)
Product Name: NIVOLUMAB - 10ml vial- COMMERCIAL
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558-01
Other descriptive name: BMS936558
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Inclusion/Exclusion Criteria (Data source: WHO)

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:
• 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

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005371-13

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2012-005371-13-IE

Further information on trial

Date trial registered

16.05.2013

Incorporation of the first participant

23.07.2013

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

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 MelanomaPharmacogenetics Blood Sample Protocol Amendment 01, version 1.0, dated 19-Mar-2013

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

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)]

Secundary end point (Data source: WHO)

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)

Contact information (Data source: WHO)

Bristol-Myers Squibb International Corporation

Trial results (Data source: WHO)

Results summary

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 MelanomaPharmacogenetics Blood Sample Protocol Amendment 01, version 1.0, dated 19-Mar-2013

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Australia, Austria, Belgium, Brazil, Canada, 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

Contact for further information on the trial

Contact for general information (Data source: WHO)

GCT-SU
Parc de l'Alliance - Avenue de Finlande, 4
Bristol-Myers Squibb International Corporation
clinical.trials@bms.com

Contact for scientific information (Data source: WHO)

GCT-SU
Parc de l'Alliance - Avenue de Finlande, 4
Bristol-Myers Squibb International Corporation
clinical.trials@bms.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Bristol-Myers Squibb International Corporation

Further trial identification numbers

Secondary ID (Data source: WHO)

CA209-067
NCT01844505
2012-005371-13-BE