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Monoclonal Antibodies

Pembrolizumab for Ovarian Cancer

Phase 2
Recruiting
Led By Janice Mehnert
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Summary

This trial looks at how effective pembrolizumab is in treating participants with cancer that has spread to other parts of the body. Monoclonal antibodies, like pembrolizumab, may prevent tumor cells from growing and spreading.

Eligible Conditions
  • Ovarian Cancer
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Solid Tumors
  • Cancer
  • POLD1 Mutation
  • Gene Mutation
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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
Response rate of pembrolizuab
Secondary outcome measures
Progression free survival

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

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment2 Interventions
Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants with disease progression may continue pembrolizumab for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,361 Total Patients Enrolled
289 Trials studying Ovarian Cancer
73,705 Patients Enrolled for Ovarian Cancer
Rutgers, The State University of New JerseyLead Sponsor
435 Previous Clinical Trials
64,983 Total Patients Enrolled
6 Trials studying Ovarian Cancer
423 Patients Enrolled for Ovarian Cancer
Janice MehnertPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
295 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03428802 — Phase 2
Ovarian Cancer Research Study Groups: Treatment (pembrolizumab)
Ovarian Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03428802 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03428802 — Phase 2
~5 spots leftby Jul 2025
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