Abstract 265TiP
Background
Patients with advanced cervical cancer comprise a high-risk, poor prognostic group. Vascular endothelial growth factor (VEGF) has emerged as a therapeutic target for these patients, though incorporation of the anti-VEGF agent bevacizumab to platinum- and taxane-based chemotherapy (CT) is associated with a modest OS benefit vs CT alone (median OS, 16.8 vs 13.3 mo; hazard ratio, 0.77, 95% CI, 0.62-0.95; P = 0.007; Tewari et al. Lancet. 2017). On the basis of an ORR of 14.3% (95% CI, 7.4-24.1) among 77 pretreated women with PD-L1–positive tumors in the cervical cancer cohort of KEYNOTE-158 (Chung et al. J Clin Oncol. 2019), the PD-1 inhibitor pembrolizumab was granted accelerated approval by the US FDA for patients with PD-L1–positive (combined positive score [CPS] of > 1) cervical cancer who had progressed during or after first-line CT. KEYNOTE-826 (NCT03635567) is a phase 3, randomized, double-blind, multinational study designed to evaluate the efficacy and tolerability of CT with or without pembrolizumab and/or bevacizumab in the first-line setting.
Trial design
Eligible patients with recurrent, persistent, or metastatic cervical cancer not previously treated with CT in a recurrent or metastatic setting who are not amenable to curative treatment will be randomized 1:1 to CT + pembrolizumab 200 mg or placebo every 3 weeks. The CT regimen (paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 or carboplatin AUC 5, with or without bevacizumab 15 mg/kg) will be selected by the investigator before randomization. Stratification will be performed by metastasis status at diagnosis, planned bevacizumab use (yes/no), and tumor PD-L1 CPS (<1, 1 to < 10, or ≥ 10). Treatment will continue for ≤35 cycles (∼2 years) or until disease progression, unacceptable toxicity, or voluntary patient withdrawal. Primary endpoints are PFS per RECIST v1.1 (assessed by blinded independent central review) and OS. Secondary endpoints are ORR, duration of response, 12-month PFS, patient-reported quality of life, and safety. Enrollment is currently ongoing.
Clinical trial identification
NCT03635567.
Legal entity responsible for the study
Merck & Co., Inc.
Funding
Funding for this study was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
K. Fujiwara: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Chugai Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eisai; Advisory / Consultancy, Research grant / Funding (institution): Merck Sharpe & Dohme Corp.; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Taiho Pharmaceutical; Advisory / Consultancy: Takeda; Honoraria (self): Bayer; Honoraria (self): Daiichi Sankyo; Honoraria (self): Janssen Oncology; Honoraria (self): Kyowa Hakko Kirin; Honoraria (self): Lilly Japan; Honoraria (self): Nippon Kayaku; Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Zeria Pharmaceutical; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Kaken Pharmaceutical; Research grant / Funding (institution): Immunogen; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Oncotherapeutics. R. Shapira-Frommer: Honoraria (self): MSD Oncology; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Novartis; Honoraria (self): Roche; Honoraria (self): AstraZeneca; Advisory / Consultancy: Vascular Biogenics; Advisory / Consultancy: Clovis Oncology. J. Alexandre: Honoraria (self): Roche/Genentech; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis ; Honoraria (self): Sanofi/Aventis; Honoraria (self), Advisory / Consultancy: Ipsen; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi; Research grant / Funding (institution), Travel / Accommodation / Expenses: Janssen. B. Monk: Advisory / Consultancy: AbbVie; Advisory / Consultancy: Advaxis; Advisory / Consultancy: Agenus; Advisory / Consultancy: Amgen; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Biodesix; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Conjupro; Advisory / Consultancy: Genmab; Advisory / Consultancy: Gradalis; Advisory / Consultancy: ImmunoGen; Advisory / Consultancy: Immunomedics; Advisory / Consultancy: Incyte; Advisory / Consultancy: Janssen/Johnson&Johnson; Advisory / Consultancy: Mateon (formally Oxigene); Advisory / Consultancy: Merck; Advisory / Consultancy: Myriad; Advisory / Consultancy: Perthera; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Precison Oncology. T. Fehm: Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Pfizer. N. Colombo: Honoraria (self), Advisory / Consultancy: Roche/Genentech; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self): TESARO, Inc.; Honoraria (self), Advisory / Consultancy: PharmaMar; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD Oncology; Advisory / Consultancy: Takeda; Advisory / Consultancy: TESARO, Inc.; Advisory / Consultancy: BioCad. K. Hasegawa: Honoraria (self), Research grant / Funding (self): Daiichi-Sankyo; Honoraria (self), Advisory / Consultancy: Merck Sharpe & Dohme Corp.; Honoraria (self): Chugai; Honoraria (self): AstraZeneca; Research grant / Funding (self): Yakult Honsha; Research grant / Funding (self): Pfizer. J.J. Li: Travel / Accommodation / Expenses, Full / Part-time employment: Merck & Co., Inc.; Travel / Accommodation / Expenses, Spouse / Financial dependant: Celgene. K. Stein: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc.; Shareholder / Stockholder / Stock options: Novartis. S.M. Keefe: Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. K. Tewari: Honoraria (self): TESARO, Inc.; Honoraria (self): Clovis Oncology; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche/Genentech; Speaker Bureau / Expert testimony: AstraZeneca ; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Morphotek; Research grant / Funding (institution): Regeneron. All other authors have declared no conflicts of interest.
Resources from the same session
427P - Sahai: A restorative support to address unmet needs of women with cancer – impact on quality of life
Presenter: Poonam Maurya
Session: Poster display session
Resources:
Abstract
428P - A pilot study on comparative efficacy of tramadol or eutectic mixture of local anaesthetics (prilocaine plus lignocaine) in preventing bone marrow aspiration associated pain
Presenter: Bipinesh Sansar
Session: Poster display session
Resources:
Abstract
429P - Skin pathologic change evaluation of the patients who had EGFR inhibitor-related skin adverse events
Presenter: Sung Yong Oh
Session: Poster display session
Resources:
Abstract
430P - Emetic risk of carboplatin plus pemetrexed is higher than that of carboplatin plus paclitaxel in patients with lung cancer: A propensity score-matched analysis
Presenter: Koichi Matsuo
Session: Poster display session
Resources:
Abstract
431P - An in vitro evaluation of CYP2D6 enzymatic inhibition activities of a Chinese herbal medicine formulation (Xiang Bei Yangrong Tang) for the management of cancer-related fatigue
Presenter: Ning Yi Yap
Session: Poster display session
Resources:
Abstract
432P - Chemotherapy induced extravasation: Incidence and possible predictors
Presenter: Shalaka Somayaji
Session: Poster display session
Resources:
Abstract
433P - Prospective outcomes of adolescent and young adult (AYA) patients received treatment from a tertiary cancer hospital in Bangladesh
Presenter: Abdullah Al Mamun Khan
Session: Poster display session
Resources:
Abstract
434P - Pneumonitis induced antineoplastic agents: Mortality and risk factors in 129 consecutive cases
Presenter: Sawako Kaku
Session: Poster display session
Resources:
Abstract
435P - Telephonic communication in palliative care for better management of terminal cancer patients in rural India: An NGO based approach
Presenter: NABANITA MANDAL
Session: Poster display session
Resources:
Abstract
436P - Assessing the quality of life of Filipino cancer patients: A survey of Filipino oncologists
Presenter: Frederic Ivan Ting
Session: Poster display session
Resources:
Abstract