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KPV

Lys-Pro-Val, α-MSH (11-13)

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Studies 104
Trials 57
Completed PHASE3 INTERVENTIONAL NCT03353831

Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.

Detailed Description

Approximately 550 patients will be randomized in a 1:1 ratio to the treatments as specified below: Arm A: Chemotherapy + Bevacizumab + Placebo Arm B: Chemotherapy + Bevacizumab + Atezolizumab Study treatment will continue until disease progression per RECIST v1.1, unacceptable toxicity, or patient or investigator decision to discontinue treatment. Atezolizumab/placebo, chemotherapy and bevacizumab may be discontinued for toxicity independently of each other in the absence of disease progression. For each patient, chemotherapy (PLD or Paclitaxel weekly) will be selected by the investigator prior to randomization. Recruitment to an individual chemotherapy cohort will be closed once 50% of patients are recruited to this cohort. In such case the remaining cohort will remain open for recruitment.

Interventions

Name: Bevacizumab
Type: DRUG
Description: Bevacizumab will be administered by intravenouse route at a dose of 10mg/kg q14 during the treatment period
Name: Atezolizumab
Type: DRUG
Description: Atezolizumab will be administered by intravenous route at a dose of 840 mg q14 during the treatment period
Name: Chemotherapy
Type: DRUG
Description: Chemotherapy (Paclitaxel or PLD) will be administered by intravenous route at different doses during the treatment period q28
Name: Placebos
Type: DRUG
Description: Placebo will be administered by intravenous route q14 during the treatment period

Primary Outcomes

Measure: Overall Survival (OS)
TimeFrame: From date of randomizationrandomization to date of death from any cause assessed up to 40 months
Description: regular patient contacts during the trial regarding life status
Measure: Progression-free survival
TimeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months
Description: Progressive Disease based on investigator assessment using RECIST v1.1

Trial Information

NCT ID

NCT03353831

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

AGO Research GmbH

Last Updated

December 15, 2025