Pembrolizumab for Ovarian Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ovarian Cancer+4 MorePembrolizumab - Biological
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Ovarian Cancer
  • Fallopian Tube Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to ~68 months

Month 68
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
Up to ~42 months
PFS per RECIST 1.1 by Blinded Independent Central Review (BICR)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator
Up to ~68 months
Number of Participants who Discontinue Study Treatment due to an AE
Number of Participants who Experience an Adverse Event (AE)
Overall Survival (OS)
TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale
Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

2 Treatment Groups

Pembrolizumab + paclitaxel ± bevacizumab
1 of 2
Placebo + paclitaxel ± bevacizumab
1 of 2

Experimental Treatment

Non-Treatment Group

616 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · Has Placebo Group · Phase 3

Pembrolizumab + paclitaxel ± bevacizumabExperimental Group · 4 Interventions: Docetaxel, Bevacizumab, Pembrolizumab, Paclitaxel · Intervention Types: Drug, Drug, Biological, Drug
Placebo + paclitaxel ± bevacizumabPlaceboComparator Group · 4 Interventions: Placebo for pembrolizumab, Docetaxel, Bevacizumab, Paclitaxel · Intervention Types: Other, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Bevacizumab
FDA approved
Pembrolizumab
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~68 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,731 Total Patients Enrolled
7 Trials studying Ovarian Cancer
2,331 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,684 Previous Clinical Trials
4,957,512 Total Patients Enrolled
35 Trials studying Ovarian Cancer
5,242 Patients Enrolled for Ovarian Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,639 Previous Clinical Trials
7,941,722 Total Patients Enrolled
11 Trials studying Ovarian Cancer
2,943 Patients Enrolled for Ovarian Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy.
Patient must have radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.
You have histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
You are a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
You have a performance status of 0 to 1 assessed within 3 days before randomization.

Who else is applying?

What state do they live in?
New York28.6%
Massachusetts28.6%
Virginia14.3%
Other28.6%
What portion of applicants met pre-screening criteria?
Met criteria100.0%