Under construction – not a live service
Sign in

NCT04495010WithdrawnPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 19 Mar 2021

Reason given: Business objectives have changed

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
0 (actual)
First submitted
30 Jul 2020
Start date
31 Mar 2021
Primary completion date
28 Feb 2024
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT04495010
EudraCT number
2020-000070-16

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with serious or uncontrolled medical disorders

Lab values

  • 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

Other

  • Women who are breastfeeding

Who the study is looking for

  • 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

Criteria the registry did not label

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (108)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-GrazAustriaUnknown status
-InnsbruckAustriaUnknown status
-SalzburgAustriaUnknown status
-Sankt PöltenAustriaUnknown status
-ViennaAustriaUnknown status
-AdelaideAustraliaUnknown status
-BallaratAustraliaUnknown status
-DoubleviewAustraliaUnknown status
-GreenslopesAustraliaUnknown status
-HobartAustraliaUnknown status
-MelbourneAustraliaUnknown status
-NedlandsAustraliaUnknown status
-North SydneyAustraliaUnknown status
-WestmeadAustraliaUnknown status
-WoolloongabbaAustraliaUnknown status
-BrusselsBelgiumUnknown status
-GhentBelgiumUnknown status
-WilrijkBelgiumUnknown status
-BrasíliaBrazilUnknown status
-CuritibaBrazilUnknown status
-FlorianópolisBrazilUnknown status
-FortalezaBrazilUnknown status
-Porto AlegreBrazilUnknown status
-Rio de JaneiroBrazilUnknown status
-São José do Rio PretoBrazilUnknown status
-São PauloBrazilUnknown status
-ZurichSwitzerlandUnknown status
-BerlinGermanyUnknown status
-ErlangenGermanyUnknown status
-EssenGermanyUnknown status
-HanoverGermanyUnknown status
-HeidelbergGermanyUnknown status
-KielGermanyUnknown status
-LübeckGermanyUnknown status
-MainzGermanyUnknown status
-RegensburgGermanyUnknown status
-TübingenGermanyUnknown status
-WürzburgGermanyUnknown status
-AarhusDenmarkUnknown status
-HerlevDenmarkUnknown status
-Odense CDenmarkUnknown status
-BarcelonaSpainUnknown status
-Haddon HeightsSpainUnknown status
-MadridSpainUnknown status
-MálagaSpainUnknown status
-OviedoSpainUnknown status
-Santiago de CompostelaSpainUnknown status
-SevilleSpainUnknown status
-BordeauxFranceUnknown status
-DijonFranceUnknown status
-LilleFranceUnknown status
-MarseilleFranceUnknown status
-NantesFranceUnknown status
-NiceFranceUnknown status
-ParisFranceUnknown status
-Pierre-BéniteFranceUnknown status
-RennesFranceUnknown status
-Sr Priest En JarezFranceUnknown status
-ToulouseFranceUnknown status
-VillejuifFranceUnknown status
-CambridgeUnited KingdomUnknown status
-GlasgowUnited KingdomUnknown status
-GuildfordUnited KingdomUnknown status
-LeedsUnited KingdomUnknown status
-LondonUnited KingdomUnknown status
-ManchesterUnited KingdomUnknown status
-NorthwoodUnited KingdomUnknown status
-OxfordUnited KingdomUnknown status
-SuttonUnited KingdomUnknown status
-BergamoItalyUnknown status
-MeldolaItalyUnknown status
-NaplesItalyUnknown status
-NovaraItalyUnknown status
-PadovaItalyUnknown status
-PaviaItalyUnknown status
-AmsterdamNetherlandsUnknown status
-BredaNetherlandsUnknown status
-GeleenNetherlandsUnknown status
-LeidenNetherlandsUnknown status
-RotterdamNetherlandsUnknown status
-UtrechtNetherlandsUnknown status
-KrakowPolandUnknown status
-WarsawPolandUnknown status
-WroclawPolandUnknown status
-KrasnodarRussiaUnknown status
-RyazanRussiaUnknown status
-Saint PetersburgRussiaUnknown status
-VaxjoSwedenUnknown status
-AnnapolisUnited StatesUnknown status
-AtlantaUnited StatesUnknown status
-AuroraUnited StatesUnknown status
-BostonUnited StatesUnknown status
-CharlottesvilleUnited StatesUnknown status
-ClevelandUnited StatesUnknown status
-GilbertUnited StatesUnknown status
-HattiesburgUnited StatesUnknown status
-HoustonUnited StatesUnknown status
-MariettaUnited StatesUnknown status
-MinneapolisUnited StatesUnknown status
-MorristownUnited StatesUnknown status
-New BrunswickUnited StatesUnknown status
-PortlandUnited StatesUnknown status
-Salt Lake CityUnited StatesUnknown status
-San FranciscoUnited StatesUnknown status
-SeattleUnited StatesUnknown status
-St LouisUnited StatesUnknown status
-TampaUnited StatesUnknown status
-TucsonUnited StatesUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.