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Chemotherapy

Chemotherapy + Pembrolizumab/Olaparib for Ovarian Cancer

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Has adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights

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.

Who is the study for?
This trial is for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. They should be candidates for specific chemotherapy, have adequate organ function, and not be pregnant or breastfeeding. Women must use effective contraception and provide a biopsy before randomization.Check my eligibility
What is being tested?
The study tests if adding pembrolizumab to carboplatin/paclitaxel chemotherapy followed by olaparib maintenance improves progression-free survival in these patients compared to chemotherapy alone. It's specifically for those without BRCA mutations but with PD-L1-positive tumors.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used, fatigue, blood disorders like anemia or clotting issues, digestive problems such as nausea or diarrhea, increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.
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My organs are functioning well.
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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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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.
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I have either completed, am eligible for, or am a candidate for surgery to remove a large portion of my tumor.
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I can provide a recent biopsy for BRCA1/2 and PD-L1 testing.
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My CA-125 to CEA ratio is 25 or higher, and I am a candidate for initial chemotherapy.
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I am eligible for carboplatin and paclitaxel chemotherapy before or after surgery.
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My cancer is advanced ovarian, peritoneal, or fallopian tube cancer.
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I can provide a recent biopsy for BRCA1/2 and PD-L1 testing.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am eligible for carboplatin and paclitaxel chemotherapy before or after surgery.
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My CA-125 to CEA ratio is 25 or higher, and I am a candidate for initial chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]≥10)
Secondary outcome measures
Mean Change from Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
Mean Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) Score Using Questions from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Number of Participants Who Discontinue Study Treatment Due to an AE
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Placebo for OlaparibExperimental Treatment6 Interventions
Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Group II: Pembrolizumab + OlaparibExperimental Treatment6 Interventions
Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Group III: Placebo for Pembrolizumab + Placebo for OlaparibActive Control6 Interventions
Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Olaparib
FDA approved
Docetaxel
FDA approved
Carboplatin
FDA approved
Bevacizumab
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,544 Total Patients Enrolled
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
69,559 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,333 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03740165 — Phase 3
Peritoneal Tumors Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03740165 — Phase 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03740165 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
65+
What site did they apply to?
MEDICAL COLLEGE OF WISCONSIN ( Site 0064)
What portion of applicants met pre-screening criteria?
Met criteria
~101 spots leftby Aug 2024