Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents

Summary

This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.

Conditions

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood

DRUG

Cediranib Maleate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Computed Tomography with Contrast

Undergo CT with contrast

BIOLOGICAL

Durvalumab

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Olaparib

Given PO

DRUG

Paclitaxel

Given IV

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

DRUG

Topotecan Hydrochloride

Given IV

Sponsors & Collaborators

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Jung-min Lee · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-10

Primary Completion

2023-01-26

Completion

2027-03-04

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations