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Alkylating agents

Pembrolizumab + Carboplatin + Paclitaxel for Epithelial Ovary Cancer

Phase 2
Waitlist Available
Led By Denise Uyar, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have advance stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Suboptimal cytoreductive surgery defined as any residual disease noted per operative report and/or have measurable/macroscopic disease based on RECIST 1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of enrollment until 18 months from initiation of therapy
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if it can improve progression-free survival in ovarian cancer patients who haven't responded well to other treatments.

Eligible Conditions
  • Ovarian Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have advanced stage ovarian, fallopian tube, or peritoneal cancer.
Select...
You have remaining cancer after surgery, or you have visible cancer based on specific guidelines.
Select...
You should be able to carry out everyday activities without any major issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of enrollment until 18 months from initiation of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of enrollment until 18 months from initiation of therapy 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) of Combination Platinum Based Therapy With Anti-Programmed Death (PD)-1 Therapy Followed by Maintenance Anti-PD-1 Therapy in Patients With Epithelial Ovarian Cancer (EOC).
Secondary outcome measures
Monitor Quality of Life During Combination Therapy and Single Agent Maintenance Therapy With Anti-PD-1 Therapy With the Functional Assessment of Cancer Therapy- Ovarian (FACT- O) Surveys at Intervals During Therapy.
Other outcome measures
PD-L1 Expression in Preserved Tissue Obtained at the Time of Initial Diagnosis for Patients

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%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chemotherapy combined with pembrolizumabExperimental Treatment3 Interventions
Single arm study: Pembrolizumab IV every 21 days (200 mg) Carboplatin IV every 21 days Paclitaxel IV infusion (80 mg/m2) every 7 days for 6 cycles Followed by 12 months pembrolizumab IV every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
604 Previous Clinical Trials
1,162,227 Total Patients Enrolled
1 Trials studying Ovarian Cancer
80 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,671 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,571 Patients Enrolled for Ovarian Cancer
The Cleveland ClinicOTHER
1,019 Previous Clinical Trials
1,365,046 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02766582 — Phase 2
Ovarian Cancer Research Study Groups: Chemotherapy combined with pembrolizumab
Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02766582 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02766582 — Phase 2

Frequently Asked Questions

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

How many individuals are being welcomed into this clinical trial?

"As of now, this clinical trial is not looking for new patients to participate. The study was originally posted on October 1st, 2016 and was last edited on April 7th, 2022. There are currently 702 other trials actively enrolling patients with ovarian cancer and 2076 Pembrolizumab studies searching for participants."

Answered by AI

Has Pembrolizumab been federally approved in the USA?

"Pembrolizumab's safety is based on data from Phase 2 trials, meaning that while there is some evidence to support its safety, there is no clinical data yet supporting its efficacy."

Answered by AI

What other scientific papers have been published on Pembrolizumab?

"Pembrolizumab is being studied in 2076 different trials, with 424 of those currently active. The great majority of these are Phase 3 studies. Most of the research is based out of Shanghai however there are 92200 locations running Pembrolizumab trials."

Answered by AI

What are the chief indications for Pembrolizumab?

"Pembrolizumab is often used to treat malignant neoplasms, but it can also be useful in treating other conditions like unresectable melanoma and high risk of recurrence."

Answered by AI

Can new patients still join this research project?

"This particular clinical trial is no longer recruiting patients. The study was created on October 1st, 2016 but has not been updated since April 7th, 2022. There are currently 702 and 2076 studies respectively for ovarian cancer and Pembrolizumab that are actively looking for participants."

Answered by AI
Recent research and studies
~3 spots leftby Mar 2025