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NCT04495010: CheckMate 7UA

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

Withdrawn Phase 2 Last updated 19 March 2021
What this trial tests

Phase 2 trial testing Nivolumab in Melanoma. Withdrawn.

Timeline
31 March 2021
Primary endpoint
28 February 2024
23 October 2027

Quick facts

Lead sponsorBristol-Myers Squibb
PhasePhase 2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Start date31 March 2021
Primary completion28 February 2024
Estimated completion23 October 2027
Sites118 locations across Denmark, France, Italy, Netherlands, Russia, Belgium, Austria, Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

12 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current Melanoma Treatments: Where Do We Stand?
    Moreira A, Heinzerling L, Bhardwaj N, Friedlander P. · · 2021 · cited 36× · PMID 33435389 · DOI 10.3390/cancers13020221
  2. Neoadjuvant treatment for stage III and IV cutaneous melanoma.
    Gorry C, McCullagh L, O'Donnell H, Barrett S, et al · · 2023 · cited 20× · PMID 36648215 · DOI 10.1002/14651858.cd012974.pub2
  3. Malignant melanoma: evolving practice management in an era of increasingly effective systemic therapies.
    Newcomer K, Robbins KJ, Perone J, Hinojosa FL, et al · · 2022 · cited 16× · PMID 35033317 · DOI 10.1016/j.cpsurg.2021.101030
  4. Trends in clinical development of pediatric cancer for PD-1 and PD-L1 inhibitors: an analysis of ClinicalTrials.gov.
    Que Y, Hu Y, Hong D, Zhang Y. · · 2021 · cited 11× · PMID 34583971 · DOI 10.1136/jitc-2021-002920
  5. Beyond Ipilimumab: a review of immunotherapeutic approaches in clinical trials in melanoma.
    Middleton G. · · 2021 · cited 7× · PMID 36284898 · DOI 10.1093/immadv/ltaa010
  6. Neoadjuvant immune checkpoint inhibitors in high-risk stage III melanoma.
    Ferraresi V, Vari S. · · 2022 · cited 6× · PMID 34882516 · DOI 10.1080/21645515.2021.1971015

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

Other recruiting trials for Melanoma

Currently open trials in the same condition.

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04495010.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing