Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants (CheckMate 7UA)

March 17, 2021 updated by: Bristol-Myers Squibb

A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma

The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

Study Overview

Status

Status

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Withdrawn

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

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 2

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
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Local Institution
      • Westmead, New South Wales, Australia, 2145
        • Local Institution
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution
      • Woolloongabba, Queensland, Australia, 4120
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Local Institution
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Local Institution
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
      • Melbourne, Victoria, Australia, 3000
        • Local Institution
    • Western Australia
      • Doubleview, Western Australia, Australia, 6018
        • Local Institution
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
  • Austria
      • Graz, Austria, 803 6
        • Local Institution
      • Innsbruck, Austria, 6020
        • Local Institution
      • Salzburg, Austria, 5020
        • Local Institution
      • St. Poelten, Austria, 3100
        • Local Institution
      • Wien, Austria, A-1090
        • Local Institution
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution
      • Gent, Belgium, 9000
        • Local Institution
      • Wilrijk, Belgium, 2610
        • Local Institution
  • Brazil
      • Rio De Janeiro, Brazil, 20220-410
        • Local Institution
      • Sao Paulo, Brazil, 01246-000
        • Local Institution
      • Sao Paulo, Brazil, 05308-020
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brazil, 60135237
        • Local Institution
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70200-730
        • Local Institution
    • Parana
      • Curitiba, Parana, Brazil, 80530-010
        • Local Institution
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
        • Local Institution
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
        • Local Institution
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90050-170
        • Local Institution
    • SAO Paulo
      • Sao Jose do Rio Preto, SAO Paulo, Brazil, 15092-415
        • Local Institution
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88034-000
        • Local Institution
  • Denmark
      • Aarhus, Denmark, 8200
        • Local Institution
      • Herlev, Denmark, 2730
        • Local Institution
      • Odense C, Denmark, 2000
        • Local Institution
  • France
      • Bordeaux, France, 33075
        • Local Institution
      • Dijon, France, 21079
        • Local Institution
      • Lille, France, 59000
        • Local Institution
      • Marseille, France, 13385
        • Local Institution
      • Nantes, France, 44093
        • Local Institution
      • Nice, France, 6200
        • Local Institution
      • Paris, France, 75010
        • Local Institution
      • Pierre-Benite, France, 69495
        • Local Institution
      • Rennes, France, 35000
        • Local Institution
      • Sr Priest En Jarez, France, 42270
        • Local Institution
      • Toulouse, France, 31059
        • Local Institution
      • Villejuif, France, 94800
        • Local Institution
  • Germany
      • Berlin, Germany, 10117
        • Local Institution
      • Erlangen, Germany, 91054
        • Local Institution
      • Essen, Germany, 45122
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Luebeck, Germany, 23538
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Regensburg, Germany, 93053
        • Local Institution
      • Tuebingen, Germany, 72076
        • Local Institution
      • Wuerzburg, Germany, 97080
        • Local Institution
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution
      • Meldola, Italy, 47014
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Novara, Italy, 28100
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Pavia, Italy, 27100
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Local Institution
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution
      • Breda, Netherlands, 4818 CK
        • Local Institution
      • Geleen, Netherlands, 6162bg
        • Local Institution
      • Leiden, Netherlands, 2333 ZA
        • Local Institution
      • Rotterdam, Netherlands, 3075 EA
        • Local Institution
      • Utrecht, Netherlands, 3584CX
        • Local Institution
  • Poland
      • Krakow, Poland, 31-115
        • Local Institution
      • Warszawa, Poland, 02-781
        • Local Institution
      • Wroclaw, Poland, 53-413
        • Local Institution
  • Russian Federation
      • Krasnodar, Russian Federation, 350000
        • Local Institution
      • Ryazan, Russian Federation, 390011
        • Local Institution
      • Saint Petersburg, Russian Federation, 197758
        • Local Institution
      • Saint-Petersburg, Russian Federation, 198255
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
      • Haddon Heights, Spain, 8035
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Malaga, Spain, 29010
        • Local Institution
      • Oviedo, Spain, 33011
        • Local Institution
      • Santiago de Compostela, Spain, 15706
        • Local Institution
      • Sevilla, Spain, 41009
        • Local Institution
  • Sweden
      • Vaxjo, Sweden, 352 34
        • Local Institution
  • Switzerland
      • Zuerich, Switzerland, CH - 8091
        • Local Institution
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Local Institution
      • Glasgow, United Kingdom, G12 0YN
        • Local Institution
      • Guildford, United Kingdom, GU2 7XX
        • Local Institution
      • Leeds, United Kingdom, LS9 7TF
        • Local Institution
      • London, United Kingdom, SE1 9RT
        • Local Institution
      • London, United Kingdom, SW3 6JJ
        • Local Institution
      • Manchester, United Kingdom, M20 4BX
        • Local Institution
      • Northwood, United Kingdom, HA6 2RN
        • Local Institution
      • Oxford, United Kingdom, OX3 7LE
        • Local Institution
      • Sutton, United Kingdom, SM2 5PT
        • Local Institution
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Local Institution
      • Tucson, Arizona, United States, 85724
        • Local Institution
    • California
      • San Francisco, California, United States, 94158
        • Local Institution
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution
    • Florida
      • Tampa, Florida, United States, 33612
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution
      • Atlanta, Georgia, United States, 30342
        • Local Institution
      • Marietta, Georgia, United States, 30060
        • Local Institution
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution
      • Boston, Massachusetts, United States, 02114
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Local Institution
      • Minneapolis, Minnesota, United States, 55455
        • Local Institution
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Local Institution
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Local Institution
      • New Brunswick, New Jersey, United States, 08901
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Local Institution
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Local Institution
    • Washington
      • Seattle, Washington, United States, 98109
        • 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Males and females, ≥ 12 years of age [Except: where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is 18 years of age or local age of majority, inclusive]
  • Diagnosed with cytologically or histologically confirmed Stage IIIB, IIIC, or IIID cutaneous melanoma as per American Joint Committee on Cancer (AJCC) staging system, with ≥ 1 clinically detectable lymph node metastases (N1b, N2b, N3b), which are measurable according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
  • Adult participants and adolescents 16 to 18 years old must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. Adolescents < 16 years old must have Lanksky Play-Performance Status scale performance of ≥ 60
  • Must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy for melanoma or unresectable/metastatic melanoma)
  • Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

  • Women who are breastfeeding
  • Patients with serious or uncontrolled medical disorders
  • Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Neoadjuvant treatment + Adjuvant treatment
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Experimental: Adjuvant treatment
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Experimental: Neo treat with patho response-driven Adju treat or observation
Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy

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
Time Frame
Event-free survival (EFS)
Time Frame: Up to 4 years
Up to 4 years

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 deaths
Time Frame: Up to 5 years
Up to 5 years
Recurrence-free survival (RFS) Time from Surgery
Time Frame: Up to 5 years
Up to 5 years
RFS Time from Adjuvant Therapy
Time Frame: Up to 5 years
Up to 5 years
Pathologic response rate (pRR) by immune-related pathologic response (irPR)
Time Frame: Up to 5 years
Up to 5 years
Concordance major pathologic response (MPR) by local and central pathology Review
Time Frame: Up to 5 years
MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
Up to 5 years
RFS by MPR
Time Frame: Up to 5 years
Up to 5 years
Incidence of Adverse Events (AEs)
Time Frame: Up to 5 years
Up to 5 years
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 5 years
Up to 5 years
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 5 years
Up to 5 years
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame: Up to 5 years
Up to 5 years
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame: Up to 5 years
Up to 5 years
Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
Time Frame: Up to 5 years
Up to 5 years

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 (Anticipated)

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.
March 31, 2021

Primary Completion (Anticipated)

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 28, 2024

Study Completion (Anticipated)

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.
October 23, 2027

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).
July 30, 2020

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.
July 30, 2020

First Posted (Actual)

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.
July 31, 2020

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.
March 19, 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.
March 17, 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.
March 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.
  • CA209-7UA
  • 2020-000070-16 (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

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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