Are you an advanced or metastatic triple-negative breast cancer (TNBC) or platinum-resistant recurrent ovarian cancer (OC) patient? Stand Up To Cancer (SU2C) is supporting a clinical trial seeking a new immunology treatment.
Current treatment options are limited, and there is no approved “standard of care” (a treatment that is established as a best approach that a physician should use to treat these cancers).
Researchers on the SU2C-Ovarian Cancer Research Fund Alliance (OCRFA) – National Ovarian Cancer Coalition (NOCC) Ovarian Dream Team have evidence that there may be a connection between patients sensitive to one of two proteins, PD-1 immune checkpoints and PARP (an enzyme that helps repair DNA when it becomes damaged). The potential synergistic interaction between these proteins is at the heart of this clinical trial designed to evaluate a novel — or a first-of-its-kind — drug combination.
This clinical trial is integrated into the SU2C-OCRFA-NOCC Dream Team: DNA Repair Therapies for Ovarian Cancer research which seeks to bring new treatments to patients faster.
Research is needed to develop a “standard of care” for patients with advanced or metastatic TNBC and patients with platinum-resistant recurrent OC. Your participation in this clinical trial will help move science forward. Your involvement is needed to help establish a standard of care using a combination of cutting-edge immunotherapies.
Key Insights for Participants
Participants may receive more attentive care because of the high level of monitoring that takes place in clinical trials. The trial team wants to determine biologically what is happening with the patient and the tumor.
Although optional, we hope patients enrolling in this trial agree to have the suggested biopsies that are recommended in the scientific design of this study. Without biopsies and studies that follow in the laboratory, the impact of a clinical trial is less effective. Real knowledge about the disease, the treatment, and the effectiveness of the drug combination is achieved only through analysis of the biopsy materials in the lab. This is where our patients can make a major contribution toward understanding their own disease, as well as helping others in the future.
Patients with either advanced or metastatic TNBC or platinum-resistant recurrent OC are eligible toenroll. There are additional criteria that must be met to participate, or that may prevent a patient from participating.
Key criteria are summarized below and can be found in detail on ClinicalTrials.gov. Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.
18 years and older
Advanced or metastatic TNBC or platinum-resistant recurrent OC
As a triple-negative breast cancer (TNBC) patient, you are eligible IF you have previously received at least one treatment regimen for advanced/metastatic disease, or if the cancer relapsed/progressed during adjuvant chemotherapy (chemotherapy that followed surgery or radiation) within one month of the regimen’s completion.
Phase 1: You are eligible for the phase 1 portion of this study if you have received up to three different chemotherapy regimens.
Phase 2: You are eligible for the phase 2 portion of this study if you have received up to two different chemotherapy regimens.
If your high-grade serous ovarian, fallopian tube, or primary peritoneal cancer has recurred after first receiving platinum-based chemotherapy, you may be eligible for this trial. You must also have experienced a good response lasting at least six months but currently be considered platinum-resistant.
Phase 1: You are eligible for the phase 1 portion of this study if you have received up to four different chemotherapy regimens.
Phase 2: You are eligible for the phase 2 portion of this study if you have been treated with up to three different chemotherapy regimens.
Either you must have “archival” tumor tissue available (a sample of your cancer previously removed and preserved by a doctor), or a fresh biopsy must be obtained before receiving treatment under this study.
If you are physically able to become pregnant, you must have a negative pregnancy test (a blood test ordered by your doctor) within the 72-hour period prior to beginning this study’s treatment and must agree to abstain from activities that could result in pregnancy from the time of enrollment until 120 days after receiving the last treatment dose in this study.
You are NOT eligible to participate in this clinical trial if you are pregnant, are expecting to conceive a child either during this study or within four months following your last treatment in this study, or are breast feeding.
You may NOT participate in this study if you have had a significant chronic illness. The full list of excluding conditions is posted on ClinicalTrials.gov, and key amont them are:
immunodeficiency or receipt of systemic steroid therapy or other forms of immunosuppressive therapies; known history of human immunodeficiency virus (HIV) or presence of HIV-1/2 antibodies; and known active hepatitis B or hepatitis C.
Here are the locations where you can participate in this clinical trial. If you or a loved one is interested, please contact the patient coordinator at your preferred site. The patient coordinator is there to help you understand every aspect of the clinical trial process and can answer any questions.
The patient coordinator will start by reviewing your medical history with you to see whether you meet all the criteria to participate. Then the coordinator will guide you through detailed “informed consent” documents that you are required to sign when you enroll in a clinical trial.
Boston - Massachusetts
Dana-Farber Cancer Institute
Project Manager, SU2C Ovarian Cancer Team
Find out if there's a trial for you. Reach out today.
Even if you do not meet the requirements for this trial, there may be other trials for you. Get started with the SU2C Clinical Trial Finder, a free and confidential cancer clinical trial matching and referral service. (Please fill out all fields and questions below to better assist you.)