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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)

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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

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE July 31, 2020
Last Update Posted Date July 31, 2020
Estimated Study Start Date  ICMJE September 28, 2020
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
Event-free survival (EFS) [ Time Frame: Up to 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
  • Recurrence-free survival (RFS) Time from Surgery [ Time Frame: Up to 5 years ]
  • RFS Time from Adjuvant Therapy [ Time Frame: Up to 5 years ]
  • Pathologic response rate (pRR) by immune-related pathologic response (irPR) [ Time Frame: 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
  • RFS by MPR [ Time Frame: Up to 5 years ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • Incidence of deaths [ Time Frame: Up to 5 years ]
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 5 years ]
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 5 years ]
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Name: Opdivo
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Name: Yervoy
Study Arms  ICMJE
  • Experimental: Neoadjuvant treatment + Adjuvant treatment
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Adjuvant treatment
    Intervention: Biological: Nivolumab
  • Experimental: Neo treat with patho response-driven Adju treat or observation
    Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2020)
657
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 23, 2027
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Australia,   Brazil,   France,   Germany,   Italy,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04495010
Other Study ID Numbers  ICMJE CA209-7UA
2020-000070-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP