Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma (CheckMate 401)

May 20, 2021 updated by: Bristol-Myers Squibb

Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
533

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Local Institution
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
      • Coffs Harbour, New South Wales, Australia, 2450
        • Local Institution
      • Gateshead, New South Wales, Australia, 2290
        • Local Institution
      • North Sydney, New South Wales, Australia, 2060
        • Local Institution
    • Northern Territory
      • Tiwi, Northern Territory, Australia, 0810
        • Local Institution
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Local Institution
      • Cairns, Queensland, Australia, 4870
        • Local Institution
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution
      • Southport, Queensland, Australia, 4215
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
      • Bedford Park, South Australia, Australia, 5402
        • Local Institution
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Local Institution
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
      • Melbourne, Victoria, Australia, 3128
        • Local Institution
      • Melbourne, Victoria, Australia, 3144
        • Local Institution
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
  • Austria
      • Graz, Austria, 8036
        • Local Institution
      • Innsbruck, Austria, 6020
        • Local Institution
      • Salzburg, Austria, 5020
        • Local Institution
      • Vienna, Austria, 1090
        • Local Institution
  • Belgium
      • Brussel, Belgium, 1090
        • Local Institution
      • Bruxelles, Belgium, 1200
        • Local Institution
  • Finland
      • Helsinki, Finland, 00290
        • Local Institution
      • Oulu, Finland, 90029
        • Local Institution
      • Tampere, Finland, 33520
        • Local Institution
      • Turku, Finland, FIN-20520
        • Local Institution
  • France
      • Angers Cedex 9, France, 49933
        • Local Institution
      • Bordeaux, France, 33075
        • Local Institution
      • Boulogne Billancourt, France, 92104
        • Local Institution
      • Clermont-Ferrand, France, 63003
        • Local Institution
      • Dijon, France, 21079
        • Local Institution
      • Grenoble Cedex 09, France, 38043
        • Local Institution
      • Le Mans Cedex 9, France, 72037
        • Local Institution
      • Lille, France, 59037
        • Local Institution
      • Marseille, France, 13385
        • Local Institution
      • Montpellier, France, 34295
        • Local Institution
      • Nantes Cedex 01, France, 44093
        • Local Institution
      • Nice, France, 06202
        • Local Institution
      • Paris, France, 75010
        • Local Institution
      • Pierre Benite Cedax, France, 69495
        • Local Institution
      • Rennes Cedex, France, 35042
        • Local Institution
      • Rouen Cedex, France, 76031
        • Local Institution
      • TOULOUSE Cedex 9, France, 31059
        • Local Institution
      • Vandoeuvre-les-Nancy, France, 54511
        • Local Institution
      • Villejuif, France, 94805
        • Local Institution
  • Germany
      • Berlin, Germany, 10117
        • Local Institution
      • Dresden, Germany, 01277
        • Local Institution
      • Erfurt, Germany, 99028
        • Local Institution
      • Erlangen, Germany, 91054
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Freiburg, Germany, 79104
        • Local Institution
      • Gottingen, Germany, 37075
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Leipzig, Germany, 04103
        • Local Institution
      • Ludwigshafen, Germany, 67063
        • Local Institution
      • Luebeck, Germany, 23538
        • Local Institution
      • Mannheim, Germany, 68167
        • Local Institution
      • Regensburg, Germany, 93053
        • Local Institution
      • Schwerin, Germany, 19049
        • Local Institution
      • Stade, Germany, 21682
        • Local Institution
    • Rhineland-palladium
      • Mainz, Rhineland-palladium, Germany, 55131
        • Local Institution
  • Ireland
      • Cork, Ireland
        • Local Institution
      • Dublin, Ireland, 4
        • Local Institution
      • Dublin, Ireland, 8
        • Local Institution
      • Dublin, Ireland, 7
        • Local Institution
      • Dublin, Ireland, 9
        • Local Institution
      • Galway, Ireland, ST4 6QG
        • Local Institution
  • Italy
      • Bari, Italy, 70124
        • Local Institution
      • Bergamo, Italy, 24127
        • Local Institution
      • Genova, Italy, 16132
        • Local Institution
      • Meldola, Italy, 47014
        • Local Institution
      • Milan, Italy, 20141
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Pisa, Italy, 56126
        • Local Institution
      • Roma, Italy
        • Local Institution
      • Roma, Italy, 00144
        • Local Institution
      • Siena, Italy, 53100
        • Local Institution
      • Terni, Italy, 05100
        • Local Institution
      • Torino, Italy, 10126
        • Local Institution
  • Norway
      • Oslo, Norway, 0424
        • Local Institution
      • Stavanger, Norway, 4011
        • Local Institution
  • Sweden
      • Eskilstuna, Sweden, 631 88
        • Local Institution
      • Gävle, Sweden, SE-80187
        • Local Institution
      • Karlskrona, Sweden, 371 85
        • Local Institution
      • Linköping, Sweden, SE-58185
        • Local Institution
      • Stockholm, Sweden, 17176
        • Local Institution
      • Sundsvall, Sweden, 164 40
        • Local Institution
      • Vasteras, Sweden, 721 89
        • Local Institution
      • Växjö, Sweden, SE-35185
        • Local Institution
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution
      • Lausanne, Switzerland, 1005
        • Local Institution
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Local Institution
      • Cottingham, United Kingdom, HU16 5JQ
        • Local Institution
      • Glasgow, United Kingdom, G12 0YN
        • Local Institution
      • Headington, United Kingdom, OX3 7LE
        • Local Institution
      • London, United Kingdom, SE1 9RT
        • Local Institution
      • Manchester, United Kingdom, M20 4BX
        • Local Institution
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Local Institution
      • Preston, United Kingdom, PR2 9HT
        • Local Institution
      • Sheffield, United Kingdom, S10 2SJ
        • Local Institution
      • Southampton, United Kingdom, SO16 6YD
        • Local Institution
      • Swansea, United Kingdom, SA2 8QA
        • Local Institution
      • Truro, United Kingdom, TR1 3LJ
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Potential subjects must have advanced Melanoma (stage III or IV as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery.
  • Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease.

NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.

  • Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.

Exclusion Criteria:

  • Leptomenigeal metastases
  • Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Combination therapy: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab specified dose on specified days
Drug: Ipilimumab
Drug: Nivolumab
EXPERIMENTAL: Monotherapy: Nivolumab
Nivolumab specified dose on specified days
Drug: Nivolumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
From first dose to 30 days after last dose (up to approximately 37 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Onset (Grades 3-4) of Select Adverse Events
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
From first dose to 30 days after last dose (up to approximately 37 months)
Time to Resolution of an Adverse Event (AE)
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
From first dose to 30 days after last dose (up to approximately 37 months)
Overall Survival (OS)
Time Frame: Up to approximately 37 months
Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive
Up to approximately 37 months
Incidence of Participants With Adverse Events
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths
From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Select Adverse Events
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Liver
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)
From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Thyroid
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)
From first dose to 30 days after last dose (up to approximately 37 months)
Objective Response Rate (ORR)
Time Frame: Up to approximately 37 months
Objective response rate is 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 all treated participants
Up to approximately 37 months
Progression Free Survival (PFS)
Time Frame: Up to approximately 37 months
Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
Up to approximately 37 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-401
  • 2015-001274-17 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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