Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma o… (NCT03556839) | Clinical Trial Compass
CompletedPhase 3
Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix
United States, France410 participantsStarted 2018-09-25
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female patients must be ≥18 years of age.
✓. Signed informed consent before any study-specific procedure
✓. Able (in the investigator´s judgment) to comply with the study protocol
✓. GOG/Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
✓. Life expectancy ≥3 months
✓. Histologically- or cytologically-confirmed diagnosis of metastatic (stage IVB), persistent, or recurrent cervical cancer (histologies other than squamous cell, adenocarcinoma, or adenosquamous will be excluded) not amenable for curative treatment with surgery and/or radiation therapy. The inclusion of patients with adenocarcinoma histology will be capped to 20% of the whole study population.
✓. No prior systemic anti-cancer therapy for metastatic or recurrent disease.
✓. Measureable disease by RECIST v1.1 criteria.
Exclusion criteria
✕. Disease that is suitable for local therapy administered with curative intent
What they're measuring
1
Progression-free survival
Timeframe: 48 months
2
Overall survival
Timeframe: 48 months
Trial details
NCT IDNCT03556839
SponsorGrupo Español de Investigación en Cáncer de Ovario
✕. Prior radiotherapy delivered using cobalt (rather than a linear accelerator)
✕. Patients with Stage IVA not amendable to concurrent chemo-radiation as primary treatment will not be eligible.
✕. Ongoing disease involving the bladder or rectum at screening/baseline
✕. Evidence of abdominal free air
✕. Bilateral hydronephrosis, unless it can be alleviated by ureteral stent(s) or percutaneous drainage
✕. Patients previously treated with chemotherapy except when used concurrently with radiation therapy. Patients who have received either concurrent paclitaxel with radiation therapy or carboplatin/paclitaxel as adjuvant therapy are ineligible for the study.
✕. Prior treatment with any anti-VEGF drug, including bevacizumab, CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4.