PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence

Author:

Eggermont Alexander MM1ORCID,Ascierto Paolo A2,Khushalani Nikhil I3,Schadendorf Dirk4,Boland Genevieve5,Weber Jeffrey6,Lewis Karl D7,Johnson Daniel8,Rivalland Gareth9,Khattak Adnan10,Majem Margarita11,Gogas Helen12,Long Georgina V13,Currie Sue L14,Chien David14,Tagliaferri Mary A14,Carlino Matteo S15,Diab Adi16

Affiliation:

1. Princess Máxima Center for Pediatric Oncology & University Medical Center Utrecht, Utrecht, Netherlands

2. Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Naples, Italy

3. H Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA

4. West German Cancer Center at the University Hospital Essen, Essen, Germany

5. Massachusetts General Hospital, Boston, MA 02114, USA

6. Perlmutter Cancer Center at NYU Langone Health, New York, NY 10016, USA

7. University of Colorado Cancer Center, Aurora, CO 80045, USA

8. Ochsner Medical Center, New Orleans, LA 70121, USA

9. University of Auckland & Auckland City Hospital, Auckland, New Zealand

10. Hollywood Private Hospital, Edith Cowan University, Perth, Australia

11. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

12. National & Kapodistrian University of Athens, Athens, Greece

13. Melanoma Institute Australia, The University of Sydney, & Royal North Shore & Mater Hospitals, Sydney, Australia

14. Nektar Therapeutics, San Francisco, CA 94158, USA

15. Westmead & Blacktown Hospitals & Melanoma Institute Australia, The University of Sydney, Sydney, Australia

16. The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

Abstract

Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, phase III, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.

Funder

Bristol-Myers Squibb

Nektar Therapeutics

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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