BEATcc (ENGOT-Cx10/GEICO 68-C/GOG3030/JGOG1084): A randomized, open label, phase III study of cisplatin and paclitaxel chemotherapy with bevacizumab (CTx plus B) with or without atezolizumab (Atz) as first-line treatment for metastatic, persistent, or recurrent (m/r) carcinoma of the cervix (CCx).

Authors

Ana Oaknin

Ana Oaknin

Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain

Ana Oaknin , Laurence Gladieff , Nicoletta Colombo , Guillermo Villacampa , Mansoor Raza Mirza , Ugo De Giorgi , Leslie M. Randall , Munetaka Takekuma , Antonio González-Martín

Organizations

Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, GINECO, Institut Claudius Regaud, Toulouse, France, MaNGO & European Institute of Oncology and University of Milan-Bicocca, Milano, Italy, Oncology Data Science (ODysSey) Group, Vall d'Hebron Institute of Oncology, Barcelona, Spain, Nordic Society of Gynecologic Oncology (NSGO) and Rigshospitalet–Copenhagen University Hospital, Copenhagen, Denmark, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy, GOG-F & University of California, Irvine, Orange, CA, JGOG, Department of Gynecology, Shizuoka Cancer Cener Hospital, Shizuoka, Japan, GEICO and Clínica Universidad de Navarra, Madrid, Spain

Research Funding

Other

Background: The combination of CTx plus B is first line treatment for most patients (pts) with m/r CCx not amenable for local therapy based on GOG240 results. GOG240 regimen showed an improvement in overall survival (OS) compared to CTx alone: 16.8 vs. 13.3 months (HR 0.77, 95% CI 0.62–0.95, p = 0.007). However, further improvement in first line therapy outcomes is an unmet need. Immune-checkpoint inhibitors are breakthrough therapies in several tumor types, and their development in CCx is supported by a strong scientific rationale. Human papillomavirus infection (HPV) causes more than 90% of CCx cases. PD-L1 is a HPV biomarker and is found frequently up-regulated in CCx. Nivolumab and pembrolizumab (Pb) (anti-PD-1 antibodies) have shown response rates of 26.3% and 14.3%, respectively, in pretreated m/r CCx. This has led to the recent FDA approval of Pb in pretreated PD-L1+ m/r CCx. The BEATcc trial (NCT03556839) evaluates the addition of the anti-PD-L1 agent Atz to GOG240 regimen as first line treatment for m/r CCx, following the synergistic rationale between anti-VEGF agents and PD-1/PD-L1 blockade. Methods: Eligible pts: m/r CC with adequate organ function. Pts will be randomized 1:1 to either Arm A (control): C 50 mg/m2 + Tx 175mg/m2 + B 15 mg/kg (CTx plus B) i.v. D1 Q3W or Arm B (experimental): CTx plus B + Atz 1200 mg i.v. D1 Q3W. Stratification factors: prior chemo-radiation, histology and Chemotherapy backbone (CTx vs carboplatin-Tx). Treatment is planned until disease progression, unacceptable toxicity or withdrawal of consent. Pts with a complete response after ≥6 cycles or those with unacceptable CTx toxicity may be allowed to continue only on biologics therapy. An Independent Data Monitoring Committee will analyze the safety of the first 12 pts in the experimental arm completing 2 treatment cycles. The primary endpoint is OS. The study started enrolling in October 2018 and will enroll approximately 404 pts across Europe, Japan, and the US. Clinical trial information: NCT03556839

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Cervical Cancer

Clinical Trial Registration Number

NCT03556839

Citation

J Clin Oncol 37, 2019 (suppl; abstr TPS5594)

DOI

10.1200/JCO.2019.37.15_suppl.TPS5594

Abstract #

TPS5594

Poster Bd #

417a

Abstract Disclosures