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NCT03556839 · ClinicalTrials.gov registry record · Phase 3
Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix
A Phase 3 study of Carcinoma of the Cervix, Stage IVB, sponsored by Grupo Español de Investigación en Cáncer de Ovario.
- Active
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
- 20
- Study locations
NCT03556839 is a Phase 3 study of Carcinoma of the Cervix, Stage IVB that is active but no longer recruiting, run by Grupo Español de Investigación en Cáncer de Ovario. The registered enrollment target is 410 participants. The trial reports 20 study locations across 3 states.
The verdict
NCT03556839, a Phase 3 study of Carcinoma of the Cervix, Stage IVB, is active but no longer recruiting, sponsored by Grupo Español de Investigación en Cáncer de Ovario.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Bevacizumab
- DRUG Atezolizumab
- DRUG Paclitaxel
- DRUG Cisplatin/Carboplatin
Study Locations (20)
Other
- ICO Paul Papin - Angers
- CHU Jean Minjoz - Besançon
- Institut Bergonié - Bordeaux
- Centre François Baclesse - Caen
- Centre Oscar Lambret - Lille
- Centre Léon Bérard - Lyon
- ICM Val d'Aurelle - Montpellier
- Hôpital Privé du Confluent S.A.S. - Nantes
- Centre Antoine Lacassagne - Nice
- Groupe Hospitalier Diaconesses-Croix Saint-Simon - Paris
- HEGP - Paris
- Centre Hospitalier Lyon Sud - Pierre-Bénite
- Centre CARIO-HPCA - Plérin
- ICO Centre René Gauducheau - Saint-Herblain
- Hôpitaux Universitaires - Strasbourg
- Institut Claudius Régaud - Toulouse
- Gustave Roussy - Villejuif
- Universitätsmedizin Mainz - Mainz
Louisiana
- Willis Knighton Cancer Center - Shreveport
Virginia
- Massey Cancer Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2025-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03556839
The ClinicalTrials.gov registry entry for NCT03556839 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grupo Español de Investigación en Cáncer de Ovario, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma of the Cervix, Stage IVB appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT03556839 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Other, Louisiana, Virginia.
Frequently Asked Questions
What is clinical trial NCT03556839 about?
NCT03556839 is a clinical study titled "Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix". 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 comb...
What is the current status of trial NCT03556839?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2018-09-25. Estimated completion is 2025-08.
What conditions does trial NCT03556839 study?
This clinical trial studies the following conditions: Carcinoma of the Cervix, Stage IVB.
What interventions are being tested in trial NCT03556839?
The interventions under investigation include: Bevacizumab (DRUG), Atezolizumab (DRUG), Paclitaxel (DRUG), Cisplatin/Carboplatin (DRUG).
Who is sponsoring clinical trial NCT03556839?
This trial is sponsored by Grupo Español de Investigación en Cáncer de Ovario, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03556839 being conducted?
This trial has 20 study locations across Louisiana, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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