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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).
Must not have
Has received prior radiation therapy within 2 weeks of start of study intervention.
Has a known history of human immunodeficiency virus (HIV) infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~64 months
Awards & highlights

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 below
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My cancer worsened within 6 months after my last platinum-based chemotherapy.
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I am eligible for paclitaxel chemotherapy.
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My cancer can be seen and measured on scans.
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I have provided a sample of my tumor tissue that has not been treated with radiation.
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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had radiation therapy less than 2 weeks ago.
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I have been diagnosed with HIV.
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I am currently being treated for an 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 have or had lung inflammation that needed steroids.
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I have an immune system disorder or am on long-term steroids.
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I have a history of Hepatitis B or active Hepatitis C.
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I have received an organ or tissue transplant from another person.
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My high blood pressure is not under control.
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I have a serious bowel blockage or related issue due to ovarian cancer.
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I have been treated for an autoimmune disease in the last 2 years.
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My condition worsened despite being treated with weekly paclitaxel.
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My cancer is not one of the specific types listed (nonepithelial, mucinous, etc.).
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I have had more than two treatments for ovarian cancer.
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I have cancer that has spread to my brain or spinal cord.
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I am receiving or eligible for bevacizumab treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~64 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~64 months for reporting.

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 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
4,581,396 Total Patients Enrolled
7 Trials studying Ovarian Cancer
2,331 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,067,647 Total Patients Enrolled
41 Trials studying Ovarian Cancer
5,830 Patients Enrolled for Ovarian Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,069,714 Total Patients Enrolled
13 Trials studying Ovarian Cancer
3,076 Patients Enrolled for Ovarian Cancer

Media Library

Paclitaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT05116189 — Phase 3
Ovarian Cancer Research Study Groups: Pembrolizumab + paclitaxel ± bevacizumab, Placebo + paclitaxel ± bevacizumab
Ovarian Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT05116189 — Phase 3
Paclitaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116189 — Phase 3
~161 spots leftby Jun 2025