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)

• ClinicalTrials.gov Identifier: NCT04495010
• Recruitment Status: Not yet recruiting
• First Posted: July 31, 2020
• Last Update Posted: July 31, 2020
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: July 30, 2020
• First Posted Date: July 31, 2020
• Last Update Posted Date: July 31, 2020
• Estimated Study Start Date: September 28, 2020
• Estimated Primary Completion Date: February 28, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 30, 2020): Event-free survival (EFS) [ Time Frame: Up to 4 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Melanoma

Intervention

• Biological: Nivolumab
  Specified dose on specified days
  Other Name: Opdivo
• Biological: Ipilimumab
  Specified dose on specified days
  Other Name: Yervoy

Study Arms

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 30, 2020): 657
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 23, 2027
• Estimated Primary Completion Date: February 28, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Australia, Brazil, France, Germany, Italy, Russian Federation, Spain, United States

Administrative Information

• NCT Number: NCT04495010
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: July 2020