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A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

Status
Active
Cancer Type
Melanoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05002569
Protocol IDs
CA224-098 (primary)
NCI-2022-02119
2021-001641-13
Study Sponsor
Bristol-Myers Squibb

Summary

The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC)
versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Eligibility

  1. Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
  2. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of = 1
  3. Complete resection must be performed within 12 weeks prior to randomization
  4. All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
  5. Tumor tissue must be provided for biomarker analyses
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.