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

Conditions

• Fallopian Tube High Grade Serous Adenocarcinoma
• Ovarian High Grade Serous Adenocarcinoma
• Ovarian Seromucinous Carcinoma
• Primary Peritoneal High Grade Serous Adenocarcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Fallopian Tube Clear Cell Adenocarcinoma
• Recurrent Fallopian Tube Endometrioid Adenocarcinoma
• Recurrent Fallopian Tube Undifferentiated Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Ovarian Clear Cell Adenocarcinoma
• Recurrent Ovarian Endometrioid Adenocarcinoma
• Recurrent Ovarian Undifferentiated Carcinoma
• Recurrent Platinum-Resistant Fallopian Tube Carcinoma
• Recurrent Platinum-Resistant Ovarian Carcinoma
• Recurrent Platinum-Resistant Primary Peritoneal Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Recurrent Primary Peritoneal Clear Cell Adenocarcinoma
• Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
• Recurrent Primary Peritoneal Undifferentiated Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV
• Bevacizumab — BIOLOGICAL
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT
• Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jun 23, 2017

Status verified

May 2026

Primary completion

May 9, 2023

Completion

May 11, 2027

Study Design

Enrollment

444 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (PLD, atezolizumab)
  Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021)
• Experimental: Arm II (PLD, bevacizumab, atezolizumab)
  Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study.
• Active Comparator: Arm III (PLD, bevacizumab)
  Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens [ Time Frame: Up to 28 days ]

Locations (909)

Related coverage on Hipa.ai

• Atezolizumab Triplet Improves PFS, OS in Recurrent Ovarian Cancer
  Atezolizumab · Mar 4, 2025 · ClinicalTrials.gov

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