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  • A Phase III study (CheckMate 238) of adjuvant immunotherapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage IIIb/c or stage IV melanoma (MEL) in patients (pts) at high risk for recurrence

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Poster Presentation
A Phase III study (CheckMate 238) of adjuvant immunotherapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage IIIb/c or stage IV melanoma (MEL) in patients (pts) at high risk for recurrence
  1. Jeffrey Weber1,
  2. Jean-Jaques Grob2,
  3. Kim A Margolin3,
  4. Paolo A Ascierto4,
  5. Mario Sznol5,
  6. Patrick A Ott6,
  7. Chantal Lejeune7,
  8. Veerle de Pril7,
  9. Mary M Ruisi8 and
  10. F Stephen Hodi6
  1. Aff1 grid.170693.a000000012353285XH. Lee Moffitt Cancer Center Tampa FL USA
  2. Aff2 grid.5399.60000000121764817Aix-Marseille University, Hopital de la Timone Marseille France
  3. Aff3 grid.240952.80000000087342732Stanford University Medical Center Valley Village CA USA
  4. Aff4 grid.417893.00000000108072568Istituto Nazionale Tumori Fondazione G. Pascale Naples Italy
  5. Aff5 grid.433818.5Yale Comprehensive Cancer Center New Haven CT USA
  6. Aff6 grid.65499.370000000121069910Dana-Farber Cancer Institute Boston MA USA
  7. Aff7 grid.476189.5Bristol-Myers Squibb, Braine l'Alleud Belgium
  8. Aff8 grid.419971.3Bristol-Myers Squibb Princeton NJ USA

http://dx.doi.org/10.1186/2051-1426-3-S2-P166

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    Meeting abstracts

    Background

    There is currently no consensus on the standard of care for pts with completely resected stage IIIB/C or stage IV MEL with no evidence of disease (NED) who are at high risk for recurrence. NIVO, a PD-1 immune checkpoint inhibitor, is approved in the United States, Europe, and Japan as monotherapy for the treatment of pts with advanced MEL and has shown a benefit in overall survival (OS) versus dacarbazine in treatment-naive pts with wild-type BRAF, metastatic MEL in a Phase III study. In a Phase I study, NIVO plus a multipeptide vaccine followed by NIVO monotherapy demonstrated promising median recurrence-free survival (RFS; 47.1 months) and median OS (not reached) as adjuvant therapy for high-risk, resected stage IIIC/IV MEL. IPI, a CTLA-4 immune checkpoint inhibitor, is approved as monotherapy for the treatment of pts with advanced MEL and has been shown to improve OS in advanced MEL and increase RFS versus placebo when used at a higher dose and more prolonged schedule in adjuvant therapy of stage III MEL. This Phase III, randomized, placebo-controlled, double-blind study will compare NIVO with IPI as adjuvant therapy in pts with stage IIIB/C and stage IV NED MEL who are at high risk for recurrence.

    Methods

    Eligible pts are ≥15 years of age, have stage IIIB/C or IV histologically confirmed MEL that is completely resected, and have been rendered disease free within 12 weeks prior to randomization. Pts having uveal MEL, a history of autoimmune disease, a condition requiring systemic corticosteroids or other immunosuppressive medications, or receiving prior systemic therapy for MEL will be excluded. Pts will be randomized 1:1 to NIVO 3 mg/kg every 2 weeks (Q2W) or IPI 10 mg/kg Q3W for 4 doses then Q12W starting at week 24, and treated until disease recurrence, unacceptable toxicity, or consent withdrawal, for up to 1 year. The primary and secondary objectives are to evaluate RFS and OS, respectively. An estimated 800 pts will be randomized. Clinical Trial registration number: NCT02388906

    Trial registration

    ClinicalTrials.gov identifier NCT02388906.