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This trial is currently closed but may be taking patients at a future date.

DNA Repair Therapies for Ovarian Cancer

Alan D. D’Andrea, MD

Dream Team LeaderDana-Farber Cancer InstituteView Bio

A graduate of Harvard College, Alan D’Andrea received his MD from Harvard Medical School in 1983. He completed his residency in Pediatrics at Children’s Hospital of Philadelphia, and a fellowship in pediatric hematology-oncology at DFCI and Children’s Hospital, Boston. Dr. D’Andrea also completed a research fellowship at the Whitehead Institute of Biomedical Research at MIT where he cloned the receptor for erythropoietin while working in the laboratory of Harvey Lodish. Dr. D’Andrea joined the staff at DFCI in 1990. His research is focused on the molecular cause of leukemia. He also investigates the pathogenesis of Fanconi anemia, a human genetic disease characterized by bone marrow failure and AML in children.

Dr. D’Andrea is internationally known for his research in the area of DNA damage and DNA repair. He is currently the Fuller-American Cancer Society Professor of Radiation Oncology at Harvard Medical School and the Director of the Center for DNA Damage and Repair at the Dana-Farber Cancer Institute. A recipient of numerous academic awards, Dr. D’Andrea is a former Stohlman Scholar of the Leukemia and Lymphoma Society, and he serves on the LLS Medical and Scientific Advisory Board. He is currently Chairman of the Career Development Selection Committee of the LLS, Chairman of the NIH Molecular and Cellular Hematology Study Section, and a member of the NCI Board of Scientific Counselors for Basic Sciences. Dr. D’Andrea is a Distinguished Clinical Investigator of the Doris Duke Charitable Trust, and a Fellow of the American Association for the Advancement of Science. He is also the recipient of the 2001 E. Mead Johnson Award, the highest award in Pediatric Research, and the 2012 G.H.A. Clowes Memorial Award from the American Association for Cancer Research.

Elizabeth Swisher, MD

Dream Team Co-LeaderUniversity of WashingtonView Bio

Elizabeth Swisher, MD, graduated cum laude from Yale University and received her medical degree from the University of California at San Diego. She completed her residency in obstetrics and gynecology at the University of Washington and a fellowship in gynecologic oncology at Washington University, St Louis. She joined the faculty at the University of Washington in 1999 where she is currently a Professor in the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology and an adjunct Professor in the Department of Medicine, Division of Medical Genetics. Both her clinical and laboratory work focus on cancer genetics. She is medical director of the Breast and Ovarian Cancer Prevention Program at the Seattle Cancer Care Alliance. Her research has been funded by the NIH, the Department of Defense, the Ovarian Cancer Research Foundation, and other cancer foundations.

Dr. Swisher’s research has primarily focused on understanding the early events of ovarian carcinogenesis and on the development of novel biomarkers of disease and prognosis, with an emphasis on the role of the BRCA-Fanconi anemia pathway. She has been exploring how a better understanding of this pathway can lead to more effective therapies and prevention of ovarian cancers. She is principal investigator on several PARP inhibitor therapeutic trials and leads the translational research for numerous other clinical trials. Her overall goal is to reduce the burden of ovarian cancer by combining broader identification of inherited risk with effective prevention.

View Full Team

Meet the Team

 

  • Alan D’Andrea, Dana-Farber Cancer Institute
  • Elizabeth Swisher, University of Washington
  • Gini Fleming, University of Chicago
  • Panos Konstantinopoulous, Partners in Healthcare
  • Scott Kaufmann, Mayo Clinic

 

Supported by collaborator Merck
. Additional compound provided by Tesaro.
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About this Catalyst Clinical Trial

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.

We Need You

Why Your Participation Matters

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 having the suggested biopsies which 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 only achieved 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.

Eligibility

Patients with either advanced or metastatic TNBC or platinum-resistant recurrent OC are eligible to enroll. 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.

Gender:
Female
Age Range:
18 years and older
Diagnosis:
Advanced or metastatic TNBC or platinum-resistant recurrent OC

Requirements

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 while on adjuvant chemotherapy (chemotherapy that followed surgery or radiation) within one month from 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.
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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.
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You must either 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, expecting to conceive a child either during this study or within four months following your last treatment in this study, or are breast feeding.
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You must NOT have undergone prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 or poly (ADP-ribose) polymerase (PARP) inhibitor.
You are NOT eligible to participate in this study if your cancer progressed while actively receiving any platinum-containing treatment or within one month from completion of a platinum-based therapy.
You are NOT eligible to participate in this study if you have a known additional malignancy that progressed or required active treatment within the last five years.
Note: You MAY participate if you did experience basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
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You may NOT participate in this study if you have had a significant chronic illness. The full list is posted on clinicaltrial.gov, and key excluding conditions are:
Immunodeficiency or are receiving systemic steroid therapy or other forms of immunosuppressive therapies; known history of human immunodeficiency virus (HIV) or have HIV 1/2 antibodies; known active hepatitis B or hepatitis C.
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Participate

You play a vital role.

Here are the locations where you can participate in this clinical trial. If 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 review and signature on detailed “informed consent” documents that are required when you enroll in a clinical trial.

Arizona – Scottsdale

HonorHealth
Joyce Schaffer
P: 480-323-1339
Contact

Massachusetts – Boston

Partners in HealthCare
Panos Konstantinopoulos, MD, PhD
P: 617-632-2334
Contact

Michigan – Detroit

Karmanos Cancer Institute
Meghan Wyse
P: 313-576-9717
Contact

Ohio – Cleveland

University Hospitals Seidman Cancer Center
Cancer Information Services
P: 1-800-641-2422

Oklahoma – Oklahoma City

University of Oklahoma Health Sciences Center
Ingrid Block, APRN, MS, CNS
P: 405-271-8777
Contact

Tennessee – Germantown

Univeristy of Tennessee, West Cancer Center
Cindy Inman
P: 901-683-0055 ext 61236
Contact

Resources

Support comes from Merck and an additional compound provided by Tesaro.
Learn More about Merck +Learn More about Tesaro +
Collaborators If you would like to learn more about the experience of participating in clinical trials, please visit these SU2C collaborators’ websites:
Ovarian Cancer Research Fund Alliance (OCRFA) +National Ovarian Cancer Coalition (NOCC) +
Dream Team For additional information about this research team and the clinical trial, click below.
SU2C-OCRFA-NOCC Ovarian Cancer Dream Team +Ovarian Dream Team +ClinicalTrials.gov +

Find out if there's a trial for you. Reach out today.

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