Your session is about to expire
← Back to Search
Taxane
Pembrolizumab + Paclitaxel +/- Bevacizumab 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
Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease).
Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~64 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining two drugs, pembrolizumab and paclitaxel, with or without bevacizumab. The goal is to see if this new combination can prolong the amount of time until the cancer progresses, compared to the current standard treatment.
Who is the study for?
This trial is for individuals with certain types of ovarian cancer who have had 1-2 previous treatments including platinum-based therapy but are now resistant to it. They must be able to undergo chemotherapy, not be pregnant or breastfeeding, and use effective contraception if applicable. People can't join if they've had recent bleeding issues, other active cancers within 3 years, severe allergies to the drugs being tested, uncontrolled high blood pressure, or infections requiring systemic treatment.Check my eligibility
What is being tested?
The study aims to see if adding Pembrolizumab (an immunotherapy drug) to Paclitaxel chemotherapy (with or without Bevacizumab) improves progression-free survival compared to a placebo plus the same chemo regimen in patients with PD-L1 positive tumors and all participants.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, immune system-related inflammation affecting various organs, fatigue, blood clots or bleeding events especially with Bevacizumab use. The specific side effects will depend on individual patient responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer worsened within 6 months after my last platinum-based chemotherapy.
Select...
I am eligible for paclitaxel chemotherapy.
Select...
My cancer can be seen and measured on scans.
Select...
I have provided a sample of my tumor tissue that has not been treated with radiation.
Select...
I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~64 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~64 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 (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator
Secondary outcome measures
Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
Number of Participants who Discontinue Study Treatment due to an AE
+5 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab + paclitaxel ± bevacizumabExperimental Treatment4 Interventions
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
Group II: Placebo + paclitaxel ± bevacizumabPlacebo Group4 Interventions
Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Paclitaxel
2011
Completed Phase 4
~5380
Bevacizumab
2013
Completed Phase 4
~5280
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,212 Total Patients Enrolled
7 Trials studying Ovarian Cancer
2,331 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,937 Total Patients Enrolled
41 Trials studying Ovarian Cancer
5,984 Patients Enrolled for Ovarian Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,870 Total Patients Enrolled
13 Trials studying Ovarian Cancer
3,076 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer got worse during or right after my first platinum-based treatment.I have not had cancer treatment or experimental drugs in the last 4 weeks.My cancer worsened within 6 months after my last platinum-based chemotherapy.I am eligible for paclitaxel chemotherapy.I had radiation therapy less than 2 weeks ago.I have been diagnosed with HIV.I am currently being treated for an infection.I have another cancer that is getting worse or was treated in the last 3 years.I have not taken any colony-stimulating factors in the last 4 weeks.I have or had lung inflammation that needed steroids.My cancer can be seen and measured on scans.I have an immune system disorder or am on long-term steroids.I have received an organ or tissue transplant from another person.I have a history of Hepatitis B or active Hepatitis C.My high blood pressure is not under control.I have a serious bowel blockage or related issue due to ovarian cancer.I've had 1 or 2 treatments for ovarian cancer, including a platinum-based one.I have provided a sample of my tumor tissue that has not been treated with radiation.I have not received a live vaccine in the last 30 days.I have been treated for an autoimmune disease in the last 2 years.I have had blood clots, bleeding in my lungs or gut in the last 6 months.I am still recovering from recent surgery and its complications.I don't have any health issues that could affect the study's results.My condition worsened despite being treated with weekly paclitaxel.My cancer is not one of the specific types listed (nonepithelial, mucinous, etc.).I have had more than two treatments for ovarian cancer.I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.I have cancer that has spread to my brain or spinal cord.You have a severe allergic reaction to pembrolizumab, paclitaxel, or bevacizumab, or any of the substances used to make them.I am not pregnant or breastfeeding and either can't have children or use effective birth control.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well.I am receiving or eligible for bevacizumab treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + paclitaxel ± bevacizumab
- Group 2: Placebo + paclitaxel ± bevacizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Could you please elaborate on other Pembrolizumab research that has been conducted?
"Pembrolizumab was first studied in 1997 and there are now over 2800 completed studies. There are 2308 ongoing studies, with a large concentration of research taking place in Edgewood, Kentucky."
Answered by AI
Is this a commonly prescribed clinical trial in our state?
"Patients are currently being accepted at the Saint Elizabeth Medical Center Edgewood-Cancer Care Center (Site 0040) in Edgewood, Kentucky, the UMass Memorial Medical Center (Site 0003) in Worcester, Massachusetts, and the CHU de Quebec - Université Laval - Hotel Dieu de Quebec (Site 0504) in Québec, Quebec. There are 33 other locations where this trial is being conducted."
Answered by AI
What is the latest word on Pembrolizumab from the FDA?
"Pembrolizumab has been deemed safe by our team with a score of 3. This is due to the fact that Pembrolizumab is in Phase 3 of testing, so there is some data to support both its safety and efficacy."
Answered by AI
How is Pembrolizumab implemented in medical treatment?
"Pembrolizumab is most often used to treat malignant neoplasms; however, it can also be used to fight unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
Who else is applying?
What state do they live in?
New York
Massachusetts
California
Other
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger