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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495010
Recruitment Status : Not yet recruiting
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Nivolumab Biological: Ipilimumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 657 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 28, 2020
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : October 23, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neoadjuvant treatment + Adjuvant treatment Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy
Experimental: Adjuvant treatment Biological: Nivolumab
Specified dose on specified days
Other Name: 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 Name: Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy


Outcome Measures
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Primary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Recurrence-free survival (RFS) Time from Surgery [ Time Frame: Up to 5 years ]
  2. RFS Time from Adjuvant Therapy [ Time Frame: Up to 5 years ]
  3. Pathologic response rate (pRR) by immune-related pathologic response (irPR) [ Time Frame: Up to 5 years ]
  4. 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

  5. RFS by MPR [ Time Frame: Up to 5 years ]
  6. Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  7. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  8. Incidence of deaths [ Time Frame: Up to 5 years ]
  9. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 5 years ]
  10. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 5 years ]
  11. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: 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) [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495010


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, California
Local Institution
San Francisco, California, United States, 94158
Contact: Site 0015         
United States, Georgia
Local Institution
Atlanta, Georgia, United States, 30322
Contact: Site 0045         
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02215
Contact: Site 0025         
United States, Mississippi
Local Institution
Hattiesburg, Mississippi, United States, 39401
Contact: Site 0042         
United States, New Jersey
Local Institution
New Brunswick, New Jersey, United States, 08901
Contact: Site 0028         
United States, Texas
Local Institution
Houston, Texas, United States, 77030
Contact: Site 0022         
United States, Virginia
Local Institution
Charlottesville, Virginia, United States, 22908
Contact: Site 0062         
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Contact: Site 0081         
Brazil
Local Institution
Sao Jose do Rio Preto, SAO Paulo, Brazil, 15092-415
Contact: Site 0043         
France
Local Institution
Bordeaux, France, 33075
Contact: Site 0029         
Local Institution
Dijon, France, 21079
Contact: Site 0053         
Local Institution
Paris, France, 75010
Contact: Site 0006         
Local Institution
Reims, France, 51100
Contact: Site 0066         
Local Institution
Toulouse, France, 31059
Contact: Site 0083         
Germany
Local Institution
Essen, Germany, 45122
Contact: Site 0019         
Italy
Local Institution
Bergamo, Italy, 24127
Contact: Site 0117         
Local Institution
Novara, Italy, 28100
Contact: Site 0055         
Local Institution
Pavia, Italy, 27100
Contact: Site 0059         
Russian Federation
Local Institution
Saint Petersburg, Russian Federation, 197758
Contact: Site 0115         
Spain
Local Institution
Madrid, Spain, 28007
Contact: Site 0116         
Local Institution
Oviedo, Spain, 33011
Contact: Site 0058         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04495010    
Other Study ID Numbers: CA209-7UA
2020-000070-16 ( EudraCT Number )
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
NADINA
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents