Clinical Trials /

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

NCT04495010

Description:

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.

Related Conditions:
  • Cutaneous Melanoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-7UA
  • SECONDARY ID: 2020-000070-16
  • NCT ID: NCT04495010

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
NivolumabOpdivoAdjuvant treatment
IpilimumabYervoyNeo treat with patho response-driven Adju treat or observation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Neoadjuvant treatment + Adjuvant treatmentExperimental
  • Nivolumab
  • Ipilimumab
Adjuvant treatmentExperimental
  • Nivolumab
Neo treat with patho response-driven Adju treat or observationExperimentalNeoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
  • Nivolumab
  • Ipilimumab

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event-free survival (EFS)
Time Frame:Up to 4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Recurrence-free survival (RFS) Time from Surgery
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:RFS Time from Adjuvant Therapy
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Pathologic response rate (pRR) by immune-related pathologic response (irPR)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Concordance major pathologic response (MPR) by local and central pathology Review
Time Frame:Up to 5 years
Safety Issue:
Description:MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
Measure:RFS by MPR
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • NADINA

Last Updated

July 30, 2020