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MelanomaPhase 2CheckMate 7UANCT04495010

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

A Phase 2 study testing Nivolumab and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 118 sites in 16 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Melanoma
What is being tested?
Nivolumab and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
118 sitesin 16 countries
Study dates
31 Mar 2021to 23 Oct 2027
Phase
Phase 2
Are there results?
None posted in the registry

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

118 sites in 16 countries.

118 sites in 16 countries

United States23 sites

  • Local Institution

    Annapolis, Maryland, 21401

  • Local Institution

    Atlanta, Georgia, 30322

  • Local Institution

    Atlanta, Georgia, 30342

  • Local Institution

    Aurora, Colorado, 80045

  • Local Institution

    Boston, Massachusetts, 02114

  • Local Institution

    Boston, Massachusetts, 02215

  • Local Institution

    Charlottesville, Virginia, 22908

  • Local Institution

    Cleveland, Ohio, 44195

  • Local Institution

    Gilbert, Arizona, 85234

  • Local Institution

    Hattiesburg, Mississippi, 39401

  • Local Institution

    Houston, Texas, 77030

  • Local Institution

    Marietta, Georgia, 30060

  • Local Institution

    Minneapolis, Minnesota, 55407

  • Local Institution

    Minneapolis, Minnesota, 55455

  • Local Institution

    Morristown, New Jersey, 07960

  • Local Institution

    New Brunswick, New Jersey, 08901

  • Local Institution

    Portland, Oregon, 97239

  • Local Institution

    Salt Lake City, Utah, 84112

  • Local Institution

    San Francisco, California, 94158

  • Local Institution

    Seattle, Washington, 98109

  • Local Institution

    St Louis, Missouri, 63110

  • Local Institution

    Tampa, Florida, 33612

  • Local Institution

    Tucson, Arizona, 85724

Other trials in United States

France12 sites

  • Local Institution

    Bordeaux, 33075

  • Local Institution

    Dijon, 21079

  • Local Institution

    Lille, 59000

  • Local Institution

    Marseille, 13385

  • Local Institution

    Nantes, 44093

  • Local Institution

    Nice, 6200

  • Local Institution

    Paris, 75010

  • Local Institution

    Pierre-Bénite, 69495

  • Local Institution

    Rennes, 35000

  • Local Institution

    Sr Priest En Jarez, 42270

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Villejuif, 94800

Other trials in France

Australia11 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Ballarat, Victoria, 3350

  • Local Institution

    Doubleview, Western Australia, 6018

  • Local Institution

    Greenslopes, Queensland, 4120

  • Local Institution

    Hobart, Tasmania, 7000

  • Local Institution

    Melbourne, Victoria, 3000

  • Local Institution

    Melbourne, Victoria, 3004

  • Local Institution

    Nedlands, Western Australia, 6009

  • Local Institution

    North Sydney, New South Wales, 2060

  • Local Institution

    Westmead, New South Wales, 2145

  • Local Institution

    Woolloongabba, Queensland, 4120

Other trials in Australia

Brazil11 sites

  • Local Institution

    Brasília, Federal District, 70200-730

  • Local Institution

    Curitiba, Paraná, 80530-010

  • Local Institution

    Florianópolis, Santa Catarina, 88034-000

  • Local Institution

    Fortaleza, Ceará, 60135237

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Local Institution

    Rio de Janeiro, 20220-410

  • Local Institution

    São José do Rio Preto, São Paulo, 15092-415

  • Local Institution

    São Paulo, 01246-000

  • Local Institution

    São Paulo, 05308-020

Other trials in Brazil

Germany11 sites

  • Local Institution

    Berlin, 10117

  • Local Institution

    Erlangen, 91054

  • Local Institution

    Essen, 45122

  • Local Institution

    Hanover, 30625

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Kiel, 24105

  • Local Institution

    Lübeck, 23538

  • Local Institution

    Mainz, 55131

  • Local Institution

    Regensburg, 93053

  • Local Institution

    Tübingen, 72076

  • Local Institution

    Würzburg, 97080

Other trials in Germany

United Kingdom10 sites

  • Local Institution

    Cambridge, CB2 0QQ

  • Local Institution

    Glasgow, G12 0YN

  • Local Institution

    Guildford, GU2 7XX

  • Local Institution

    Leeds, LS9 7TF

  • Local Institution

    London, SE1 9RT

  • Local Institution

    London, SW3 6JJ

  • Local Institution

    Manchester, M20 4BX

  • Local Institution

    Northwood, HA6 2RN

  • Local Institution

    Oxford, OX3 7LE

  • Local Institution

    Sutton, SM2 5PT

Other trials in United Kingdom

Netherlands7 sites

  • Local Institution

    Amsterdam, 1066CX

  • Local Institution

    Amsterdam, 1081 HV

  • Local Institution

    Breda, 4818 CK

  • Local Institution

    Geleen, 6162bg

  • Local Institution

    Leiden, 2333 ZA

  • Local Institution

    Rotterdam, 3075 EA

  • Local Institution

    Utrecht, 3584CX

Other trials in Netherlands

Spain7 sites

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Haddon Heights, 8035

  • Local Institution

    Madrid, 28007

  • Local Institution

    Málaga, 29010

  • Local Institution

    Oviedo, 33011

  • Local Institution

    Santiago de Compostela, 15706

  • Local Institution

    Seville, 41009

Other trials in Spain

Italy6 sites

  • Local Institution

    Bergamo, 24127

  • Local Institution

    Meldola, 47014

  • Local Institution

    Naples, 80131

  • Local Institution

    Novara, 28100

  • Local Institution

    Padova, 35128

  • Local Institution

    Pavia, 27100

Other trials in Italy

Austria5 sites

  • Local Institution

    Graz, 803 6

  • Local Institution

    Innsbruck, 6020

  • Local Institution

    Salzburg, 5020

  • Local Institution

    Sankt Pölten, 3100

  • Local Institution

    Vienna, A-1090

Other trials in Austria

Russia4 sites

  • Local Institution

    Krasnodar, 350000

  • Local Institution

    Ryazan, 390011

  • Local Institution

    Saint Petersburg, 197758

  • Local Institution

    Saint Petersburg, 198255

Other trials in Russia

Belgium3 sites

  • Local Institution

    Brussels, 1200

  • Local Institution

    Ghent, 9000

  • Local Institution

    Wilrijk, 2610

Other trials in Belgium

Denmark3 sites

  • Local Institution

    Aarhus, 8200

  • Local Institution

    Herlev, 2730

  • Local Institution

    Odense C, 2000

Other trials in Denmark

Poland3 sites

  • Local Institution

    Krakow, 31-115

  • Local Institution

    Warsaw, 02-781

  • Local Institution

    Wroclaw, 53-413

Other trials in Poland

Sweden1 site

  • Local Institution

    Vaxjo, 352 34

Other trials in Sweden

Switzerland1 site

  • Local Institution

    Zurich, CH - 8091

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Melanoma
Being tested
Nivolumab, 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 Opdivo

    Specified dose on specified days

  • IpilimumabBiological

    Also called Yervoy

    Specified dose on specified days

Study groups in NCT04495010
Study groupRoleWhat they receive
Neoadjuvant treatment + Adjuvant treatmentExperimentalNot described
Receives: Biological: Nivolumab; Biological: Ipilimumab
Adjuvant treatmentExperimentalNot described
Receives: Biological: Nivolumab
Neo treat with patho response-driven Adju treat or observationExperimentalNeoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
Receives: Biological: Nivolumab; Biological: Ipilimumab

What is being measured

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

  1. Event-free survival (EFS)

    Measured: Up to 4 years

Secondary outcomes (12)

  1. Recurrence-free survival (RFS) Time from Surgery

    Measured: Up to 5 years

  2. RFS Time from Adjuvant Therapy

    Measured: Up to 5 years

  3. Pathologic response rate (pRR) by immune-related pathologic response (irPR)

    Measured: Up to 5 years

  4. Concordance major pathologic response (MPR) by local and central pathology Review

    MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR

    Measured: Up to 5 years

  5. RFS by MPR

    Measured: Up to 5 years

  6. Incidence of Adverse Events (AEs)

    Measured: Up to 5 years

  7. Incidence of Serious Adverse Events (SAEs)

    Measured: Up to 5 years

  8. Incidence of deaths

    Measured: Up to 5 years

  9. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Measured: Up to 5 years

  10. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Measured: Up to 5 years

  11. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Measured: Up to 5 years

  12. Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)

    Measured: Up to 5 years

Timeline

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

  1. First posted31 Jul 2020
  2. Study start31 Mar 2021 (estimated)
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion23 Oct 2027 (estimated)

Why it stopped: Business objectives have changed

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04495010
Sponsor's protocol ID
CA209-7UA
Other IDs
2020-000070-16
Acronym
CheckMate 7UA
Status last verified
Mar 2021
First submitted
30 Jul 2020
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.

    PubMed 36648215

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 118 sites in 16 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 4 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: withdrawn, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, France, Australia, Brazil, Germany and 11 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Event-free survival (EFS) (time frame: Up to 4 years). 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 NCT04495010, which also lists 1 linked publication.

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 19 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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