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OpenTrials
Completed

NCT Number: NCT07091695

Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab

The purpose of this study is to understand the characteristics of adults diagnosed with with clinically palpable stage III resectable melanoma, the associated treatment patterns for their disease, and outcomes associated with the real-world use of neoadjuvant nivolumab+relatlimab or nivolumab+ipilimumab

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardinal Health

Dublin, Ohio, 43017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants at least 18 years old at diagnosis of clinically palpable stage III resectable melanoma
  • Participants treated with nivolumab+relatimab (nivo+rela) or nivolumab+ipilimumab (nivo+ipi) in the neoadjuvant setting
  • Participants with at least 6 months of follow-up from initiation of neoadjuvant therapy, unless deceased prior to 6 months of follow-up

Exclusion criteria

  • Participants received nivo+rela or nivo+ipi for clinically palpable stage III resectable melanoma as part of a therapeutic clinical trial
  • Participants had history of diagnosis of any malignancy (except for non-melanoma skin cancer) in the last 2 years.
  • Participants received adjuvant nivo+rela or adjuvant nivo+ipi after neoadjuvant nivo+ipi
  • Participants received adjuvant nivo+ipi after neoadjuvant nivo+rela
  • Participants received any systemic therapy prior to the initiation of neoadjuvant nivo+rela or nivo+ipi

Treatment and study plan

Nivolumab + Relatlimab

Biological

As prescribed by the treating clinician

Nivolumab + ipilimumab

Biological

As prescribed by the treating clinician

Primary outcomes

  1. Participant baseline demographics

    Time frame: Baseline

  2. Participant baseline clinical characteristics

    Time frame: Baseline

  3. Participant treatment history

    Time frame: Baseline

  4. Number of doses of index therapies received (neoadjuvant therapies)

    Time frame: Day 1

  5. Types of surgeries received for melanoma after the index date

    Time frame: Up to 42-months

  6. Date of last radiation received for melanoma after the index date

    Time frame: Up to 42-months

  7. Types of regimens received for melanoma post-surgery in the adjuvant setting

    Time frame: Up to 42-months

  8. Number of doses of adjuvant therapies received (post-surgery)

    Time frame: Up to 42-months

  9. Dose modifications received by participants

    Time frame: Up to 42-months

  10. Rationale for dose modifications

    Time frame: Up to 42-months

  11. Rationale for treatment discontinuation

    Time frame: Up to 42-months

  12. Overall survival (OS)

    Time frame: Up to 42-months

  13. Time to treatment discontinuation (TTD)

    Time frame: Up to 42-months

  14. Duration of treatment (DOT)

    Time frame: Up to 42-months

  15. Time from neoadjuvant index treatment to adjuvant therapy

    Time frame: Up to 42-months

  16. Time from neoadjuvant index treatment to surgery

    Time frame: Up to 42-months

  17. Time from surgery to adjuvant therapy

    Time frame: Up to 42-months

  18. Pathologic complete response (PCR)

    Time frame: Up to 42-months

  19. Event-free survival (EFS)

    Time frame: Up to 42-months

  20. Distant metastasis-free survival (DMFS)

    Time frame: Up to 42-months

  21. Participant adverse events (AEs)

    Time frame: Up to 42-months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab (Nivo+Rela) or Nivolumab+Ipilimumab (Nivo+Ipi)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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