Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix

Summary

The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.

The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).

This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

Conditions

• Carcinoma of the Cervix, Stage IVB

Interventions

DRUG

Atezolizumab

Intravenous Infusion

DRUG

Bevacizumab

Intravenous Infusion

DRUG

Cisplatin/Carboplatin

Intravenous Infusion

DRUG

Paclitaxel

Intravenous Infusion

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP

  collaborator OTHER

• Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies

  collaborator UNKNOWN

• MaNGO

  collaborator UNKNOWN

• NSGO

  collaborator UNKNOWN

• Japanese Gynecologic Oncology Group

  collaborator OTHER

• Gynecologic Oncology Group Foundation

  collaborator UNKNOWN

• AGO Study Group

  collaborator OTHER

• Apices Soluciones S.L.

  collaborator INDUSTRY

• Hoffmann-La Roche

  collaborator INDUSTRY

• Grupo Español de Investigación en Cáncer de Ovario

  lead OTHER

Principal Investigators

• Ana Oaknin, MD PhD · Vall d´Hebron University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-25

Primary Completion

2025-08-31

Completion

2025-08-31

FDA Drug

Yes

Countries

• United States
• France
• Germany
• Italy
• Japan
• Norway
• Spain
• Sweden

Study Locations