PIVOT-12: a Phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence
Por:
Eggermont, AMM, Ascierto, PA, Khushalani, NI, Schadendorf, D, Boland, G, Weber, J, Lewis, KD, Johnson, D, Rivalland, G, Khattak, A, Majem, M, Gogas, H, Long, GV, Currie, SL, Chien, D, Tagliaferri, MA, Carlino, MS, Diab, A
Publicada:
1 mar 2022
Ahead of Print:
1 ene 2022
Resumen:
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-L1 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 Ill, 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.
Lay abstract: Following surgery, patients with advanced melanoma may require further treatment to reduce the likelihood of disease recurrence. Nivolumab (NIVO), a checkpoint inhibitor, reduces the risk of melanoma recurrence by enhancing the ability of the immune system to fight disease. Despite the availability of NIVO and other therapies, many patients with melanoma still experience disease recurrence after surgery. This article presents information on a clinical trial named PIVOT-12, which aims to assess the effectiveness of a new investigational drug called bempegaldesleukin that modifies the immune system and is given with NIVO to patients with stage III/IV melanoma following surgery. The main end point being measured is recurrence-free survival, which measures the time between a patient starting the study and the date of disease recurrence.
Filiaciones:
Eggermont, AMM:
Princess Maxima Ctr Pediat Oncol, Utrecht, Netherlands
Univ Med Ctr Utrecht, Utrecht, Netherlands
Ascierto, PA:
Ist Nazl Tumori IRCCS Fdn G Pascale, Naples, Italy
Khushalani, NI:
H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL 33612 USA
Schadendorf, D:
Univ Hosp Essen, West German Canc Ctr, Essen, Germany
Boland, G:
Massachusetts Gen Hosp, Boston, MA 02114 USA
Weber, J:
NYU Langone Hlth, Perlmutter Canc Ctr, New York, NY 10016 USA
Lewis, KD:
Univ Colorado Canc Ctr, Aurora, CO 80045 USA
Johnson, D:
Ochsner Med Ctr, New Orleans, LA 70121 USA
Rivalland, G:
Univ Auckland, Auckland, New Zealand
Auckland City Hosp, Auckland, New Zealand
Khattak, A:
Edith Cowan Univ, Hollywood Private Hosp, Perth, WA, Australia
Majem, M:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Gogas, H:
Natl & Kapodistrian Univ Athens, Athens, Greece
Long, GV:
Univ Sydney, Melanoma Inst Australia, Sydney, NSW, Australia
Royal North Shore Hosp, Sydney, NSW, Australia
Mater Hosp, Sydney, NSW, Australia
Currie, SL:
Nektar Therapeut, San Francisco, CA 94158 USA
Chien, D:
Nektar Therapeut, San Francisco, CA 94158 USA
Tagliaferri, MA:
Nektar Therapeut, San Francisco, CA 94158 USA
Carlino, MS:
Univ Sydney, Melanoma Inst Australia, Sydney, NSW, Australia
Univ Sydney, Westmead Hosp, Sydney, NSW, Australia
Univ Sydney, Blacktown Hosp, Sydney, NSW, Australia
Diab, A:
Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
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