Study on Oregovomab Plus Chemotherapy for Newly Diagnosed Advanced Ovarian Cancer After Surgery

Sponsor: CanariaBio Inc.

Sponsor score: 0

ClinicalTrials ID:NCT04498117

This clinical trial is testing whether adding the drug oregovomab to standard chemotherapy can improve treatment outcomes for patients with advanced ovarian cancer who have had successful surgery to remove as much of the cancer as possible.

Patient Parameters

Parameter	Options

Program Overview

The study aims to compare the safety and effectiveness of oregovomab, a new drug, with a placebo when combined with standard chemotherapy drugs paclitaxel and carboplatin. This is for patients who have been newly diagnosed with advanced ovarian cancer and have undergone surgery to remove most of the cancer. The trial will involve two groups: one receiving oregovomab with chemotherapy and the other receiving a placebo with chemotherapy.

Description

This is a Phase 3 study where neither the patients nor the doctors know who is receiving oregovomab or a placebo. The study will take place at multiple centers and will involve two groups of patients.

Cohort 1: Patients who have had primary surgery to remove the cancer will receive six cycles of chemotherapy with either oregovomab or a placebo.
Cohort 2: Patients who have had three cycles of chemotherapy before surgery will receive another three cycles of chemotherapy with either oregovomab or a placebo after surgery.

The study will include about 372 patients in Cohort 1 and about 230 patients in Cohort 2, with half receiving oregovomab and half receiving a placebo. The goal is to see if oregovomab can improve treatment outcomes compared to the standard chemotherapy alone.

Eligibility Criteria

Inclusion Criteria

Adults aged 18 or older.
Newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer (Stage III or IV).
Specific types of cancer cells, such as high-grade serous or endometrioid adenocarcinoma.
Have had successful surgery to remove most of the cancer.
For Cohort 1, must start chemotherapy within 6 weeks after surgery.
For Cohort 2, must have had three cycles of chemotherapy before surgery and start the next cycle within 6 weeks after surgery.
Must have good blood, liver, and kidney function.
Women of childbearing potential must use effective birth control during and after the study.
Must be willing to sign a consent form and complete quality of life questionnaires.

Exclusion Criteria

Have certain genetic mutations (BRCA1 or BRCA2) if planning to use specific maintenance therapies.
Have certain types of cancer, like mucinous adenocarcinoma or carcinosarcoma.
Pregnant or breastfeeding women.
Have serious medical or psychiatric conditions that could interfere with the study.
Have active autoimmune diseases requiring treatment.
Allergic to study drugs or their components.
Using immunosuppressive drugs or corticosteroids.
Have certain infections like untreated hepatitis or HIV.
Have had another cancer within the last 5 years, except for certain skin or cervical cancers.
Have heart conditions or other serious health issues.
Unable to understand or sign the consent form.
Have received certain treatments or vaccines recently.

Locations

FACILITY	ZIP	CITY	STATE
Honor Health	85016	Phoenix	Arizona
The University of Arizona Cancer Center	85724	Tucson	Arizona
John Muir Health Clinical Research Center	94520	Concord	California
Kaiser Permanente Southern California	92120	Irvine	California
Moores UC San Diego Cancer Center	92093	La Jolla	California
Kaiser Permanente Los Angeles Medical Center	90027	Los Angeles	California
Epic Care	94523	Pleasant Hill	California
Kaiser Permanente Riverside Medical Center	95505	Riverside	California
University of California, Davis Comprehensive Cancer Center	95817	Sacramento	California
Contra Costa Oncology	94598	Walnut Creek	California

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