Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002) Journal Article

Authors: Santin, A. D.; Deng, W.; Frumovitz, M.; Buza, N.; Bellone, S.; Huh, W.; Khleif, S.; Lankes, H. A.; Ratner, E. S.; O'Cearbhaill, R. E.; Jazaeri, A. A.; Birrer, M.
Article Title: Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002)
Abstract: Purpose: Patients with persistent/recurrent cervical cancer following platinum-based chemotherapy have limited therapeutic options. The Gynecologic-Oncology-Group conducted a phase II trial to assess efficacy and tolerability of nivolumab, an immune checkpoint inhibitor, in persistent/recurrent cervical carcinoma. Patients and methods: Key eligibility criteria included persistent/recurrent cervical cancer, failure of prior systemic therapy and ECOG PS 0-1. Nivolumab 3 mg/kg was given IV every 2 wk. until disease progression or intolerable toxicity. Response was assessed every 8 wk. for 6 months and every 12 wk. thereafter. The primary endpoints were objective response as assessed by RECIST 1.1. The study used a 2-stage group sequential design. PD-L1 expression was evaluated in tumor specimens by immunohistochemistry (IHC) using a combined-positive-score (CPS) cutoff of ≥1%. Results: Of 26 enrolled patients with persistent/recurrent cervical cancer, 25 were evaluable for response/toxicity with a median age of 45. 36% had ECOG PS of 1, and 100% had received one prior systemic chemotherapy regimen. PD-L1 expression (≥1%) was identified in 77.3% of tumor samples. As of 03/05/19, all patients were off study treatment; median follow-up for survival status was 32 months (range, 2–41.5). There were 21 (84%) patients with a treatment-related adverse event (TRAE) and most were grades 1–2. Six (24%) patients had grade 3 TRAEs with 1 discontinuing nivolumab due to hepatic toxicity. No grade 5 TRAEs occurred, and 2 patients had grade 4 TRAEs. One confirmed partial response (4%; 90% CI, 0.4%–22.9%), duration of response 3.8 months. Thirty-six percent of patients had stable disease (SD) (9/25; 90% CI, 20.2%–54.4%); the median duration of SD was 5.7 months (range, 3.5–12.7). Estimated PFS and OS at 6 months were 16% and 78.4%, respectively. Conclusion: Single agent nivolumab exhibited low antitumor activity and an acceptable safety profile in patients with persistent/recurrent cervical cancer previously treated with platinum-based chemotherapy. © 2019 Elsevier Inc.
Keywords: immunohistochemistry; adult; cancer chemotherapy; cancer survival; clinical article; protein expression; treatment response; aged; overall survival; cancer recurrence; drug withdrawal; nuclear magnetic resonance imaging; follow up; antineoplastic agent; progression free survival; computer assisted tomography; infection; liver toxicity; phase 2 clinical trial; heart disease; immunotherapy; recurrent disease; skin disease; adenosquamous carcinoma; hyperbilirubinemia; amylase blood level; neurologic disease; gastrointestinal disease; hepatobiliary disease; bilirubin blood level; metabolic disorder; disease exacerbation; thorax disease; endocrine disease; amylase; hematologic disease; uterine cervix carcinoma; vascular disease; respiratory tract disease; breast disease; pd-1; programmed death 1 ligand 1; genital system disease; hyperamylasemia; cervical neoplasms; ear disease; mediastinum disease; nutritional disorder; uterine cervix adenocarcinoma; nivolumab; inner ear disease; human; female; priority journal; article; infestation; immune-checkpoint inhibitors
Journal Title: Gynecologic Oncology
Volume: 157
Issue: 1
ISSN: 0090-8258
Publisher: Elsevier Inc.  
Date Published: 2020-04-01
Start Page: 161
End Page: 166
Language: English
DOI: 10.1016/j.ygyno.2019.12.034
PUBMED: 31924334
PROVIDER: scopus
PMCID: PMC7127981
Notes: Article -- Source: Scopus
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