IGFBP-2 Vaccine to Prevent Ovarian Cancer from Getting Worse in Patients with Blood Test Detection of Recurrence

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT07495124

This study is testing a vaccine called IGFBP-2, given after a dose of carboplatin, to see if it can stop ovarian cancer from growing or spreading in patients whose cancer has returned and is detected only through blood tests.

Patient Parameters

Parameter	Options

Program Overview

This phase II study is exploring whether the IGFBP-2 vaccine, given after one dose of the chemotherapy drug carboplatin, can help prevent ovarian cancer from worsening in patients whose cancer recurrence is detected only through blood tests after previous platinum chemotherapy. IGFBP-2 is a protein found in ovarian cancer cells, and the vaccine may help the immune system attack these cells. Carboplatin is a chemotherapy drug that can activate the immune system against tumors. The study aims to see if this combination can effectively stop cancer progression.

Description

In this study, patients will receive one dose of carboplatin through an IV as part of their standard care a few days before starting the vaccine. Then, they will receive the IGFBP-2 vaccine through a small injection into the skin on the first day of each treatment cycle. These cycles will repeat every 4 weeks for up to 3 cycles, as long as the cancer does not progress and there are no severe side effects. Patients who complete the initial vaccine series may be eligible for up to 3 more vaccines, after another dose of carboplatin, 18 months after the first vaccination. Throughout the study, patients will have blood tests and imaging scans like CT or MRI to monitor their condition. After finishing the study treatment, patients will have follow-up visits at 4 weeks, then every 4 weeks for a year, and every 6 months for two more years.

Eligibility Criteria

Inclusion Criteria

Diagnosed with ovarian, fallopian tube, or primary peritoneal cancer and have received platinum-based chemotherapy.
Cancer antigen 125 (CA-125) levels returned to normal after first-line therapy.
CA-125 levels have increased to more than twice the normal limit or twice the lowest value after recent treatment.
No measurable disease based on specific criteria; ascites and pleural effusions are not considered measurable if they are not causing symptoms.
Agree to use contraception during the study if there is a risk of pregnancy.
Expected to live at least 3 more months.
Willing to provide written consent to participate.
Aged 18 or older.
Good overall health with a performance status of 0 or 1.
Meet specific blood and organ function criteria based on recent tests.

Exclusion Criteria

Currently in another study or received investigational treatment within 4 weeks before starting this study.
Have an immune deficiency or are on high-dose steroids or other immune-suppressing treatments recently.
Have symptomatic fluid buildup in the abdomen or around the lungs.
History of certain types of ovarian cancer with low malignant potential.
Received certain cancer treatments recently and have not recovered from side effects.
Have another progressing cancer or require active treatment for another cancer.
Have active brain metastases or cancer in the brain lining.
Have an active autoimmune disease needing treatment in the past 2 years.
Have an active infection needing treatment.
Have a condition or treatment that could interfere with the study.
Pregnant, breastfeeding, or planning to become pregnant during the study.
Have significant heart disease.
Have severe allergies to carboplatin or uncontrolled asthma.
Have a condition that prevents receiving certain supportive treatments.
Have HIV, active hepatitis B, or hepatitis C.
Received a live vaccine recently.

Locations

FACILITY	ZIP	CITY	STATE
Fred Hutch/University of Washington Cancer Consortium	98109	Seattle	Washington

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