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Chemo + Immunotherapy for Advanced Ovarian Cancer
Phase 2
Waitlist Available
Led By Rebecca Arend, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery.
Participant has adequate organ function as follows; all screening laboratory tests should be performed within 7 days of enrollment: Absolute neutrophil count (ANC) ≥1500/μL, Platelets ≥100 000/μL, Hemoglobin ≥8.0 g/dL or ≥5.6 mmol/L, Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥51 mL/min for participant with creatinine levels >1.5 × institutional ULN, Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases), International normalized ratio (INR) OR prothrombin time (PT); Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Must not have
Participant is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks.
Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests 3 chemo drugs on ovarian cancer patients before and after surgery to remove the tumor.
Who is the study for?
This trial is for women over 18 with advanced (Stage III/IV) ovarian cancer, who haven't had treatment yet. They should be in good health otherwise, not pregnant or breastfeeding, and willing to use contraception. Women must have a certain level of organ function and a specific tumor type to join.
What is being tested?
The study tests three chemotherapy drugs—Carboplatin, Paclitaxel (Taxol), and Pembrolizumab—before surgery to remove the tumor. After surgery, Olaparib combined with Pembrolizumab is given as maintenance therapy to prevent cancer from coming back.
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, allergic reactions to the drugs used, kidney or liver issues due to drug toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for carboplatin and paclitaxel chemotherapy before surgery to reduce my tumor size.
Select...
My blood counts and organ functions are within the required ranges for the study.
Select...
I have advanced ovarian, peritoneal, or fallopian tube cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My CA-125 to CEA ratio is 25 or higher, making me a candidate for chemotherapy before surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking strong or moderate drugs that affect liver enzymes and can't stop them for the study.
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I have a serious health condition that is not under control.
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My blood pressure is not controlled, with readings over 140/90 mm Hg.
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I am taking medication that affects how drugs are processed in my body and cannot stop them for the study.
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I have a serious bowel blockage or tear linked to my ovarian cancer.
Select...
I have an active tuberculosis infection.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I am currently being treated for an infection.
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I have been diagnosed with HIV.
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I have a history of hepatitis B or active hepatitis C.
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I have had treatment for advanced ovarian cancer, including chemotherapy or immunotherapy.
Select...
I have previously been treated with olaparib or another PARP inhibitor.
Select...
I have a serious health condition that is not under control.
Select...
My ovarian tumor is mucinous, germ cell, or borderline.
Select...
I have or had lung inflammation treated with steroids.
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I cannot take pills by mouth or have a condition that affects how my body absorbs medication.
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I am highly allergic to pembrolizumab, olaparib, carboplatin, paclitaxel, or their ingredients.
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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.
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I have received an organ or tissue transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival
Secondary study objectives
Adverse events (CTCAE v5.0)
Progression free survival at 12 months
Progression free survival at 24 months
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgeryExperimental Treatment2 Interventions
neoadjuvant carbo/taxol/pembro followed by maintenance olaparib/pembro post- surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,696 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,452 Patients Enrolled for Ovarian Cancer
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,355 Total Patients Enrolled
13 Trials studying Ovarian Cancer
2,235 Patients Enrolled for Ovarian Cancer
Rebecca Arend, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
112 Total Patients Enrolled
2 Trials studying Ovarian Cancer
112 Patients Enrolled for Ovarian Cancer
Rebecca ArendPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking strong or moderate drugs that affect liver enzymes and can't stop them for the study.I have not had a whole blood transfusion in the last 4 months but may have had other blood component transfusions over a month ago.I have a serious health condition that is not under control.I am a woman aged 18 or older.My blood pressure is not controlled, with readings over 140/90 mm Hg.I am taking medication that affects how drugs are processed in my body and cannot stop them for the study.I am eligible for carboplatin and paclitaxel chemotherapy before surgery to reduce my tumor size.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My blood counts and organ functions are within the required ranges for the study.I have a serious bowel blockage or tear linked to my ovarian cancer.I have not had bleeding issues like coughing up blood or active stomach bleeding in the last 6 months.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control advice if I can.I have advanced ovarian, peritoneal, or fallopian tube cancer.I have brain metastases but am stable and haven't used steroids for them in the last 14 days.I have an autoimmune disease treated with medication in the last 2 years.Your recent heart test shows that you have serious heart problems that are not under control, or a specific heart condition called long QT syndrome.I have an active tuberculosis infection.I have another cancer that is getting worse or was treated in the last 3 years.I am currently being treated for an infection.I have been diagnosed with HIV.I have a history of hepatitis B or active hepatitis C.I have had treatment for advanced ovarian cancer, including chemotherapy or immunotherapy.I have previously been treated with olaparib or another PARP inhibitor.I have a serious health condition that is not under control.I had surgery for early ovarian or fallopian tube cancer less than 6 months ago.My ovarian tumor is mucinous, germ cell, or borderline.I have or had lung inflammation treated with steroids.I cannot take pills by mouth or have a condition that affects how my body absorbs medication.I am fully active or restricted in physically strenuous activity but can do light work.My CA-125 to CEA ratio is 25 or higher, making me a candidate for chemotherapy before surgery.I am highly allergic to pembrolizumab, olaparib, carboplatin, paclitaxel, or their ingredients.You are allergic to the ingredients in olaparib.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I have received an organ or tissue transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.