A Randomized Phase III Trial of Platinum Chemotherapy plus Paclitaxel with Bevacizumab and Atezolizumab versus Platinum Chemotherapy plus Paclitaxel and Bevacizumab in Metastatic (stage IVB), Persistent, or Recurrent Carcinoma of the Cervix (BEATcc )

Conditions

Metastatic (stage IVB), or Recurrent Carcinoma of the Cervix, Persistent

Brief summary

Progression free survival (PFS), Overall Survival (OS)

Detailed description

Objective Response Rate (ORR), Duration of response (DOR), Frequency and severity of adverse events, Time from randomization to first subsequent therapy or death (TFST), Time from randomization to second progression (PFS2) based on radiologic assessment, start of a new line of therapy, symptomatic deterioration or death, Mean and mean changes from baseline score in patient function (role, physical) and GHS/HRQoL., Proportion of patients reporting each response option, Utility scores of the EQ-5D-5L questionnaire., Relationship between tumour immune-related or disease type-related biomarkers., Relationship between certain exploratory biomarkers, Relationship between ATB use within 2 months before and 1 month after the first study administration with atezolizumab efficacy as measured by PFS and OS.

Related papers

No related papers found yet.

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS), Overall Survival (OS)	—

Secondary

Measure	Time frame
Objective Response Rate (ORR), Duration of response (DOR), Frequency and severity of adverse events, Time from randomization to first subsequent therapy or death (TFST), Time from randomization to second progression (PFS2) based on radiologic assessment, start of a new line of therapy, symptomatic deterioration or death, Mean and mean changes from baseline score in patient function (role, physical) and GHS/HRQoL., Proportion of patients reporting each response option, Utility scores of the EQ-5D-5L questionnaire., Relationship between tumour immune-related or disease type-related biomarkers., Relationship between certain exploratory biomarkers, Relationship between ATB use within 2 months before and 1 month after the first study administration with atezolizumab efficacy as measured by PFS and OS.	—

Measure

Time frame

Objective Response Rate (ORR), Duration of response (DOR), Frequency and severity of adverse events, Time from randomization to first subsequent therapy or death (TFST), Time from randomization to second progression (PFS2) based on radiologic assessment, start of a new line of therapy, symptomatic deterioration or death, Mean and mean changes from baseline score in patient function (role, physical) and GHS/HRQoL., Proportion of patients reporting each response option, Utility scores of the EQ-5D-5L questionnaire., Relationship between tumour immune-related or disease type-related biomarkers., Relationship between certain exploratory biomarkers, Relationship between ATB use within 2 months before and 1 month after the first study administration with atezolizumab efficacy as measured by PFS and OS.

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Countries

France, Germany, Italy, Norway, Spain, Sweden

Outcome results

None listed