AzTrials
AzTrials

Unresectable or Metastatic MelanomaPhase 3NCT01844505

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

A Phase 3 study testing Nivolumab and Ipilimumab in people with Unresectable or Metastatic Melanoma, run by Bristol-Myers Squibb at 150 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable or Metastatic Melanoma
What is being tested?
Nivolumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
945 participants
Where
150 sitesin 22 countries
Study dates
11 Jun 2013to 19 Apr 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment naïve patients
  • Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
  • Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Who cannot join

  • 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-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

Trial locations and contacts

150 sites in 22 countries.

150 sites in 22 countries

United States46 sites

  • Local Institution - 0079

    Albany, New York, 12206

  • Local Institution - 0068

    Albuquerque, New Mexico, 87106

  • Local Institution - 0061

    Allentown, Pennsylvania, 18102

  • Local Institution - 0087

    Ann Arbor, Michigan, 48109

  • Local Institution - 0051

    Atlanta, Georgia, 30322

  • Local Institution - 0052

    Aurora, Colorado, 80045

  • Local Institution - 0112

    Bethlehem, Pennsylvania, 18015

  • Local Institution - 0081

    Boston, Massachusetts, 02215

  • Local Institution - 0082

    Boston, Massachusetts, 02215

  • Local Institution - 0083

    Boston, Massachusetts, 02215

  • Local Institution - 0047

    Charlotte, North Carolina, 28204

  • Local Institution - 0007

    Cleveland, Ohio, 44106

  • Local Institution - 0044

    Dallas, Texas, 75246

  • Texas Oncology

    Dallas, Texas, 75246

  • Local Institution - 0048

    Durham, North Carolina, 27710

  • Local Institution - 0085

    Gilbert, Arizona, 85234

  • Local Institution - 0154

    Greenville, South Carolina, 29605

  • Local Institution - 0088

    Houston, Texas, 77210

  • Local Institution - 0065

    Jackson, Mississippi, 39216

  • Local Institution - 0042

    Jacksonville, Florida, 32207

  • Local Institution - 0046

    La Jolla, California, 92093-0698

  • Local Institution - 0015

    Las Vegas, Nevada, 89148

  • Local Institution - 0053

    Los Angeles, California, 90025

  • Local Institution - 0014

    Los Angeles, California, 90095

  • Local Institution - 0080

    Lutherville, Maryland, 21093

  • Local Institution - 0187

    Minneapolis, Minnesota, 55407

  • Local Institution - 0188

    Morristown, New Jersey, 07962

  • Local Institution - 0062

    Nashville, Tennessee, 37203

  • Local Institution - 0064

    Nashville, Tennessee, 37232

  • Local Institution - 0084

    New Haven, Connecticut, 06520

  • Local Institution - 0174

    New York, New York, 10016

  • Local Institution - 0070

    New York, New York, 10020

  • Local Institution - 0008

    Orlando, Florida, 32806

  • Comprehensive Cancer Center At Desert Regional Medical Ctr

    Palm Springs, California, 92262

  • Local Institution - 0069

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0045

    Portland, Oregon, 97213

  • Local Institution - 0066

    Rancho Mirage, California, 92270

  • Local Institution - 0089

    Salt Lake City, Utah, 84112

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94115

  • Local Institution - 0049

    San Francisco, California, 94143

  • Maine Center For Cancer Medicine

    Scarborough, Maine, 04074

  • Local Institution - 0054

    Seattle, Washington, 98109

  • Local Institution - 0067

    St Louis, Missouri, 63110

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Local Institution - 0098

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0183

    Washington D.C., District of Columbia, 20010

Other trials in United States

Australia14 sites

  • Local Institution - 0020

    Adelaide, South Australia, 5000

  • Local Institution - 0024

    Box Hill, Victoria, 3128

  • Local Institution - 0019

    Brisbane, Queensland, 4120

  • Local Institution - 0017

    Camperdown, New South Wales, 2050

  • Local Institution - 0031

    Coffs Harbour, New South Wales, 2450

  • Local Institution - 0028

    Gateshead, New South Wales, 2290

  • Local Institution - 0016

    Heidelberg, Victoria, 3084

  • Local Institution - 0025

    Kurralta Park, South Australia, 5037

  • Local Institution - 0023

    Macquarie University, New South Wales, 2109

  • Local Institution - 0026

    Melbourne, Victoria, 3000

  • Local Institution - 0021

    Nedlands, Western Australia, 6009

  • Local Institution - 0138

    North Sydney, New South Wales, 2060

  • Local Institution - 0022

    Southport, Queensland, 4215

  • Local Institution - 0018

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany10 sites

  • Local Institution - 0162

    Buxtehude, 21614

  • Local Institution - 0161

    Erfurt, 99089

  • Local Institution - 0171

    Erlangen, 91054

  • Local Institution - 0156

    Essen, 45147

  • Local Institution - 0159

    Hanover, 30625

  • Local Institution - 0157

    Heidelberg, 69120

  • Local Institution - 0158

    Kiel, 24105

  • Local Institution - 0178

    Leipzig, 04103

  • Local Institution - 0160

    München, 80337

  • Local Institution - 0134

    Tübingen, 72076

Other trials in Germany

Italy9 sites

  • Local Institution - 0176

    Bergamo, 24127

  • Local Institution - 0115

    Genova, 16132

  • Local Institution - 0113

    Meldola (FC), 47014

  • Local Institution - 0172

    Milan, 20133

  • Local Institution - 0117

    Milan, 20141

  • Local Institution - 0114

    Naples, 80131

  • Local Institution - 0118

    Padova, Padova

  • Local Institution - 0177

    Roma, 00144

  • Local Institution - 0116

    Siena, 53100

Other trials in Italy

Canada7 sites

  • Local Institution - 0140

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0141

    London, Ontario, N6A 4L6

  • Local Institution - 0139

    Montreal, Quebec, H2X 3E4

  • Local Institution - 0143

    Ottawa, Ontario, K1H 8L6

  • Local Institution - 0142

    Québec, Quebec, G1J 1Z4

  • Local Institution - 0166

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0165

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

France7 sites

  • Local Institution - 0125

    Boulogne-Billancourt, 92104

  • Local Institution - 0126

    Marseille, 13385

  • Local Institution - 0056

    Nantes, 44093

  • Local Institution - 0058

    Paris, 75475

  • Local Institution - 0124

    Pierre-Bénite, 69310

  • Local Institution - 0127

    Rennes, 35042

  • Local Institution

    Villejuif, 94805

Other trials in France

Spain7 sites

  • Local Institution - 0152

    Badalona-Barcelona, 08916

  • Local Institution - 0151

    Barcelona, 08035

  • Local Institution - 0175

    Barcelona, 08036

  • Local Institution - 0150

    Madrid, 28007

  • Local Institution - 0149

    Madrid, 28046

  • Local Institution - 0153

    Málaga, 29010

  • Local Institution - 0147

    Pamplona, 31008

Other trials in Spain

United Kingdom7 sites

  • Local Institution - 0037

    Cambridge, CB2 2QQ

  • Local Institution - 0039

    Glasgow, Dumfries & Galloway, G12 0YN

  • Local Institution - 0038

    London, Greater London, SW3 6JJ

  • Local Institution - 0119

    Manchester, Greater Manchester, M20 4XB

  • Local Institution - 0041

    Northwood, Middlesex, HA6 2JR

  • Local Institution - 0122

    Nottingham, Nottinghamshire, NG5 1PB

  • Local Institution - 0040

    Swansea, SA2 8QA

Other trials in United Kingdom

Ireland6 sites

  • Local Institution - 0033

    Cork, T12DFK4

  • Local Institution - 0035

    Dublin, Dublin

  • Local Institution - 0168

    Dublin, 01

  • Local Institution - 0036

    Dublin, 7

  • Local Institution - 0034

    Dublin

  • Local Institution - 0032

    Galway, 0

Other trials in Ireland

Belgium5 sites

  • Local Institution - 0003

    Brussels, 1090

  • Local Institution - 0002

    Brussels, 1200

  • Local Institution - 0004

    Edegem, 2650

  • Local Institution - 0005

    Ghent, 9000

  • Local Institution - 0103

    Leuven, 3000

Other trials in Belgium

Czechia4 sites

  • Local Institution - 0092

    Brno, 656 53

  • Local Institution - 0091

    Hradec Králové, 500 05

  • Local Institution - 0090

    Prague, 128 08

  • Local Institution - 0167

    Prague, 180 81

Other trials in Czechia

Poland4 sites

  • Local Institution - 0109

    Gdansk, 80-952

  • Local Institution - 0133

    Krakow, 31-115

  • Local Institution - 0060

    Lodz, 93-513

  • Local Institution - 0059

    Warsaw, 02-781

Other trials in Poland

Russia4 sites

  • Local Institution - 0130

    Moscow, 115478

  • Local Institution - 0132

    Saint Petersburg, 197758

  • Local Institution - 0128

    Saint Petersburg, 198255

  • Local Institution - 0131

    Samara, 443031

Other trials in Russia

Switzerland4 sites

  • Local Institution - 0164

    Geneva, 1211

  • Local Institution - 0189

    Lausanne, 1011

  • Local Institution - 0186

    Sankt Gallen, 9007

  • Local Institution - 0163

    Zurich, 8091

Other trials in Switzerland

Denmark3 sites

  • Local Institution - 0076

    Aarhus, 8200

  • Local Institution - 0078

    Herlev, 2730

  • Local Institution - 0077

    Odense, 5000

Other trials in Denmark

Netherlands3 sites

  • Local Institution - 0010

    Amsterdam, 1066 CX

  • Local Institution - 0012

    Leiden, 2333 ZA

  • Local Institution - 0013

    Nijmegen, 6525 GC

Other trials in Netherlands

Austria2 sites

  • Local Institution - 0148

    Salzburg, 5020

  • Local Institution - 0145

    Vienna, 1090

Other trials in Austria

Finland2 sites

  • Local Institution - 0071

    Helsinki, Uusimaa, 00290

  • Local Institution - 0169

    Tampere, 33521

Other trials in Finland

Israel2 sites

  • Local Institution - 0120

    Jerusalem, 91120

  • Local Institution - 0121

    Tel HaShomer, 52621

Other trials in Israel

Sweden2 sites

  • Local Institution - 0182

    Gothenberg, 413 45

  • Local Institution - 0184

    Stockholm, 171 76

Other trials in Sweden

New Zealand1 site

  • Local Institution - 0029

    Auckland, 1142

Other trials in New Zealand

Norway1 site

  • Local Institution - 0123

    Oslo, 0424

Other trials in Norway

About this study

Official title: 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

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.

Being tested
Nivolumab, Ipilimumab, Placebo for Nivolumab, Placebo for Ipilimumab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called BMS-936558, MDX-1106

  • IpilimumabBiological

    Also called Yervoy, BMS-734016, MDX-010

  • Placebo for NivolumabBiological

  • Placebo for IpilimumabBiological

Study groups in NCT01844505
Study groupRoleWhat they receive
Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for NivolumabExperimentalNivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Receives: Biological: Nivolumab; Biological: Placebo for Nivolumab; Biological: Placebo for Ipilimumab
Arm B: Nivolumab+Ipilimumab+Placebo for NivolumabExperimentalNivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Receives: Biological: Nivolumab; Biological: Ipilimumab; Biological: Placebo for Nivolumab
Arm C: Ipilimumab+Placebo for NivolumabExperimentalIpilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends (Placebo matching with Nivolumab is no longer required)
Receives: Biological: Ipilimumab; Biological: Placebo for Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred 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. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

    Measured: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)

  2. Overall Survival (OS)

    OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Measured: From randomization to date of death (Assessed up to September 2016, approximately 39 months)

  3. Rate of Overall Survival

    OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.

    Measured: 24 months

  4. Rate of Progression-Free Survival

    PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred 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. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

    Measured: 24 months

Secondary outcomes (11)

  1. Progression Free Survival (PFS)

    PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred 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. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

    Measured: From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)

  2. Overall Survival (OS)

    OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Measured: From randomization until death (assessed up to approximately 128 months)

  3. Objective Response Rate (ORR) Per Investigator Assessment

    The ORR was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.

    Measured: From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)

  4. Progression-Free Survival Based on PD-L1 Expression Level

    PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 >=5% or PD-L1 <5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.

    Measured: From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)

  5. Overall Survival Based on PD-L1 Expression Level

    OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Measured: From randomization until death (assessed up to approximately 128 months)

  6. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status

    Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

    Measured: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

  7. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning

    Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

    Measured: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

  8. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning

    Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

    Measured: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

  9. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning

    Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

    Measured: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

  10. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning

    Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

    Measured: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

  11. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning

    Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

    Measured: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2013 (estimated)
  2. Study start11 Jun 2013
  3. Primary completion1 Aug 2016
  4. Study completion19 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
945 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01844505
Sponsor's protocol ID
CA209-067
Other IDs
2012-005371-13
Status last verified
May 2025
First submitted
29 Apr 2013
Last updated
21 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.

    PubMed 39504507

  • Wolchok JD, Chiarion-Sileni V, Rutkowski P, Cowey CL, Schadendorf D, Wagstaff J, Queirolo P, Dummer R, Butler MO, Hill AG, Postow MA, Gaudy-Marqueste C, Medina T, Lao CD, Walker J, Marquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schoffski P, Carlino MS, Sandhu S, Lebbe C, Ascierto PA, Long GV, Ritchings C, Nassar A, Askelson M, Benito MP, Wang W, Hodi FS, Larkin J; CheckMate 067 Investigators. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. N Engl J Med. 2025 Jan 2;392(1):11-22. doi: 10.1056/NEJMoa2407417. Epub 2024 Sep 15.

    PubMed 39282897

  • Mantia CM, Werner L, Stwalley B, Ritchings C, Tarhini AA, Atkins MB, McDermott DF, Regan MM. Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 Feb 1;32(1):35-44. doi: 10.1097/CMR.0000000000000793.

    PubMed 34855329

  • Wolchok JD, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Butler MO, Hill A, Marquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bas T, Ritchings C, Larkin J, Hodi FS. Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma. J Clin Oncol. 2022 Jan 10;40(2):127-137. doi: 10.1200/JCO.21.02229. Epub 2021 Nov 24.

    PubMed 34818112

  • Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

    PubMed 31562797

  • Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, Lao CD, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hill A, Hogg D, Marquez-Rodas I, Jiang J, Rizzo J, Larkin J, Wolchok JD. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480-1492. doi: 10.1016/S1470-2045(18)30700-9. Epub 2018 Oct 22.

    PubMed 30361170

  • Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbe C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11.

    PubMed 28889792

  • Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Marquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.

    PubMed 28662232

  • Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.

    PubMed 28651159

  • Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31.

    PubMed 26027431

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab and Ipilimumab in people with Unresectable or Metastatic Melanoma, run by Bristol-Myers Squibb at 150 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Australia, Germany, Italy, Canada and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01844505, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in