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Chemo + Immunotherapy for Advanced Ovarian Cancer
Phase 2
Waitlist Available
Led By Rebecca Arend
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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My blood counts and organ functions are within the required ranges for the study.
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I have advanced ovarian, peritoneal, or fallopian tube cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My CA-125 to CEA ratio is 25 or higher, making me a candidate for chemotherapy before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Adverse events (CTCAE v5.0)
Progression free survival at 12 months
Progression free survival at 24 months
+2 moreTrial 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
~6670
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,533 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,580 Patients Enrolled for Ovarian Cancer
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,024 Total Patients Enrolled
14 Trials studying Ovarian Cancer
1,418 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still able to join this experiment?
"Clinicaltrials.gov information suggests that this trial has concluded its recruitment period, with the initial posting of August 1st 2023 and last update on July 18th 2023. However, there are 686 other studies seeking participants at present."
Answered by AI
What has been the observed impact of administering Carbo/taxol/pembro followed by maintenance of olaparib/pembro after surgery for patients?
"Our team at Power gauged the safety of Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgery to be a 2. This is because this clinical trial is in its second phase, meaning that there are some data suggesting safety but no evidence for effectiveness yet."
Answered by AI
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