BENITIONSClinical Trial Intelligence

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 2/3 Active, not recruiting NCT02839707

ConditionFallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
PhasePhase 2/3
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment444 participants
InterventionsAtezolizumab, Bevacizumab, Computed Tomography, Pegylated Liposomal Doxorubicin Hydrochloride, Quality-of-Life Assessment
Start dateJun 23, 2017
Completion dateMay 9, 2023
Results postedMar 4, 2025

Summary

This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens

Up to 28 days · Participants

Arm I (PLD, Atezolizumab)0 Participants
Arm II (PLD, Bevacizumab, Atezolizumab)0 Participants
Arm III (PLD, Bevacizumab)0 Participants

Progression Free Survival (PFS) (Phase II)

From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years · months

Arm I (PLD, Atezolizumab)4.2 months
Arm II (PLD, Bevacizumab, Atezolizumab)7.6 months
Arm III (PLD, Bevacizumab)5.5 months

PFS (Phase III)

From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years. · months

Arm I (PLD, Atezolizumab)4.0 months
Arm II (PLD, Bevacizumab, Atezolizumab)7.4 months
Arm III (PLD, Bevacizumab)5.6 months

Open in BENITIONS View on ClinicalTrials.gov

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