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Chemotherapy + Pembrolizumab/Olaparib for Ovarian Cancer
Study Summary
This trial is testing a new combination of drugs to treat ovarian cancer. The new combination is pembrolizumab, carboplatin/paclitaxel, and maintenance olaparib. The hypothesis is that this new combination will be better than just carboplatin/paclitaxel at treating ovarian cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have or had hepatitis B or C.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I had major surgery less than 3 weeks ago or am still recovering from one.I am experiencing severe side effects from recent chemotherapy, except for hair loss.I haven't been in a drug or device trial within the last 4 weeks.My heart test shows uncontrolled conditions or I have a long QT syndrome.I have not had active treatment for another cancer, except for certain skin cancers or localized cancers, in the last 3 years.My organs are functioning well.I have advanced ovarian, peritoneal, or fallopian tube cancer.My ovarian tumor is mucinous, germ cell, or borderline.I have been treated with specific immune therapy for cancer.You are a woman of childbearing potential who is pregnant, breastfeeding, or planning to become pregnant during the study and for some time after the study ends.I am fully active or restricted in physically strenuous activity but can do light work.I have received drugs to boost my white blood cells within the last 4 weeks.I have had treatment for ovarian cancer, including radiation or chemotherapy.I am highly allergic to pembrolizumab, olaparib, carboplatin, paclitaxel, bevacizumab or their ingredients.I have received an organ or tissue transplant from a donor.I have either completed, am eligible for, or am a candidate for surgery to remove a large portion of my tumor.I am currently being treated for an infection.I can provide a recent biopsy for BRCA1/2 and PD-L1 testing.My CA-125 to CEA ratio is 25 or higher, and I am a candidate for initial chemotherapy.I am receiving or planning to receive chemotherapy directly into my abdomen as my first treatment.You have been diagnosed with HIV in the past.I have been treated with olaparib or another PARP inhibitor before.I am eligible for carboplatin and paclitaxel chemotherapy before or after surgery.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have an active tuberculosis infection.My cancer is advanced ovarian, peritoneal, or fallopian tube cancer.I have or had lung inflammation treated with steroids.I have not received a live vaccine in the last 30 days.I had surgery for early ovarian or fallopian tube cancer less than 6 months ago.I cannot take pills by mouth or have a condition that affects how my body absorbs medication.I can provide a recent biopsy for BRCA1/2 and PD-L1 testing.I have bowel issues due to my ovarian cancer and am receiving bevacizumab.I have a harmful BRCA1 or BRCA2 gene mutation.I am fully active or restricted in physically strenuous activity but can do light work.I have had, or am eligible for, surgery to remove as much cancer as possible.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I am taking strong or moderate drugs that affect liver enzymes and can't stop them for the study.I have brain metastases but am stable and haven't used steroids for them in the last 14 days.I am taking medication that strongly affects my liver and cannot stop during the study.I have a serious health condition that is not under control.I haven't had any bleeding issues in the past 6 months.My high blood pressure is not under control.I am eligible for carboplatin and paclitaxel chemotherapy before or after surgery.My organs are functioning well.My CA-125 to CEA ratio is 25 or higher, and I am a candidate for initial chemotherapy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the status of Docetaxel's FDA approval?
"Docetaxel received a safety rating of 3 because there is both efficacy and safety data available from Phase 3 clinical trials."
Are volunteers still being recruited for this research project?
"This clinical trial is not enrolling patients at the moment. The study was first posted on December 18th, 2018 and updated most recently on August 22nd, 2022. If you are looking for other studies, there 764 trials actively recruiting patients with peritoneal neoplasms and 2703 Docetaxel clinical trials currently open to participants."
How many people are being included in this research project?
"As of 8/22/2022, this study is not recruiting patients. It was initially posted on 12/18/2018. However, there are presently 764 studies actively recruiting patients with peritoneal neoplasms and 2703 trials for Docetaxel that are looking for participants."
What are we hoping to learn from participating patients in this clinical trial?
"The aim of this trial, which will be conducted over a period of up to 57 months, is to measure the progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator in all participants. Secondary outcomes include time to discontinuation of study treatment or death (TDT), pathological complete response (pCR) rate, and PFS2 following discontinuation of study treatment as assessed by the investigator in all participants."
At how many different facilities is this trial being overseen?
"At the moment, there are 51 sites which are recruiting patients for this trial. If you enroll, it would be best to choose a clinic that is close to your location in order to limit travel. The locations include Vallejo, Sioux Falls and Chicago as well as 51 other places."
Is Docetaxel a common drug used in medical research?
"Docetaxel was first researched in 1997 at City of Hope Comprehensive Cancer Center. Since the initial study, there have been 3263 completed trials. As of right now, 2703 clinical trials are recruiting patients with many of these studies based in Vallejo, South dakota."
What is the primary indication for Docetaxel?
"Docetaxel can help patients with malignant melanoma of the skin, recurrent cervical cancer, and refractory or relapsed mediastinal large b-cell lymphoma."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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