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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04495010
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Mar 31, 2021
Status verified
Mar 2021
Primary completion
Feb 28, 2024
Completion
Oct 23, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant treatment + Adjuvant treatment
  • Experimental: Adjuvant treatment
  • Experimental: Neo treat with patho response-driven Adju treat or observation
    Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: Up to 4 years ]

Locations (23)

FacilityCityStateZIPSite coordinators
Local InstitutionGilbertArizona85234-
Local InstitutionTucsonArizona85724-
Local InstitutionSan FranciscoCalifornia94158-
Local InstitutionAuroraColorado80045-
Local InstitutionTampaFlorida33612-
Local InstitutionAtlantaGeorgia30322-
Local InstitutionAtlantaGeorgia30342-
Local InstitutionMariettaGeorgia30060-
Local InstitutionAnnapolisMaryland21401-
Local InstitutionBostonMassachusetts02114-
Local InstitutionBostonMassachusetts02215-
Local InstitutionMinneapolisMinnesota55407-
Local InstitutionMinneapolisMinnesota55455-
Local InstitutionHattiesburgMississippi39401-
Local InstitutionSt LouisMissouri63110-
Local InstitutionMorristownNew Jersey07960-
Local InstitutionNew BrunswickNew Jersey08901-
Local InstitutionClevelandOhio44195-
Local InstitutionPortlandOregon97239-
Local InstitutionHoustonTexas77030-
Local InstitutionSalt Lake CityUtah84112-
Local InstitutionCharlottesvilleVirginia22908-
Local InstitutionSeattleWashington98109-

Find similar trials in Gilbert, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Local Institution· Gilbert, AZLocal Institution· Tucson, AZLocal Institution· San Francisco, CALocal Institution· Aurora, COLocal Institution· Tampa, FLLocal Institution· Atlanta, GA

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