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Monoclonal Antibodies
Pembrolizumab for Recurrent Ovarian Cancer
Phase 2
Recruiting
Led By Gottfried Konecny
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performed within 10 days of treatment initiation: serum creatinine OR measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) =< 1.5 x upper limit of normal (ULN) OR >= 45 mL/min for subject with creatinine levels > 1.5 x institutional ULN
Have received 1-5 prior lines for treating ROC (i.e. 2-6 total prior lines counting the front line) and must have a platinum-free interval (PFI) or a treatment-free interval (TFI) >= 3 months based on the last regimen received
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial studies pembrolizumab to treat ovarian cancer that has come back. Monoclonal antibodies, like pembrolizumab, may help stop the growth and spread of cancer cells.
Who is the study for?
This trial is for individuals with recurrent ovarian cancer, including peritoneal and fallopian tube cancers. Participants must have had 1-5 previous treatments, a gap of at least 3 months since the last treatment, be in good physical condition (ECOG 0 or 1), and have adequate organ function. Women of childbearing age must agree to use contraception during the study and for four months after.Check my eligibility
What is being tested?
The trial is testing Pembrolizumab, a monoclonal antibody designed to block cancer growth by interfering with tumor cells' ability to evade immune detection. It's given to participants whose ovarian cancer has returned despite prior treatments.See study design
What are the potential side effects?
Pembrolizumab can cause side effects such as fatigue, skin reactions, diarrhea, liver inflammation (hepatitis), hormone gland problems (like thyroid dysfunction), infusion-related reactions, and it may worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function tests are within the required range.
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I've had 1-5 treatments for recurrent ovarian cancer and no treatment in the last 3 months.
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I have received initial treatment with platinum-based chemotherapy.
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My cancer is a type of ovarian cancer that has come back.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) assessed per immune related Response Evaluation Criteria in Solid Tumors (irRECIST)
Secondary outcome measures
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Progression-free survival (PFS) assessed per irRECIST
Side 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
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention
Participants receive pembrolizumab intravenously IV on day 1. Courses repeat every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity.
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?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,541 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,045 Total Patients Enrolled
6 Trials studying Ovarian Cancer
212 Patients Enrolled for Ovarian Cancer
Gottfried KonecnyPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from any major surgery before starting treatment.I have or had lung inflammation not caused by an infection.I have stable brain metastases, not using steroids, and no carcinomatous meningitis.My white blood cell count is high enough for treatment.I have been diagnosed with HIV.My cancer has grown in an area that was previously treated with radiation.My kidney function tests are within the required range.I have only received the flu shot, not the nasal spray vaccine.My hemoglobin level is sufficient without recent transfusions or EPO use.I practice abstinence as my form of birth control.I have a history of active tuberculosis.I've had 1-5 treatments for recurrent ovarian cancer and no treatment in the last 3 months.I have received initial treatment with platinum-based chemotherapy.I agree to use birth control during and up to 120 days after the study.I have not received a live vaccine in the last 30 days.My cancer is a type of ovarian cancer that has come back.I have another cancer besides skin or in situ cervical cancer that needs treatment.I am currently being treated for an infection.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.I have provided a sample of my tumor tissue for testing.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am fully active or restricted in physically strenuous activity but can do light work.I have mild to moderate nerve damage.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What are the Food and Drug Administration's thoughts on Pembrolizumab?
"Pembrolizumab is still being studied in Phase 2 clinical trials, so there is not yet definitive proof of its efficacy. However, the data collected thus far suggests that it is a safe medication."
Answered by AI
With how many people is this test being conducted?
"That is correct. The information available on clinicaltrials.gov verifies that this trial, which was originally posted on March 6th 2019 and last updated on November 18th 2021, is still recruiting patients. They are looking for 30 individuals to participate at 3 different locations."
Answered by AI
What other scientific papers have been published that mention Pembrolizumab?
"City of Hope first began to study pembrolizumab in 2010 and, since then, there have been 249 completed studies. As of now, there are 1,000 ongoing trials worldwide; a significant portion of these taking place in Rochester, California."
Answered by AI
Are there any new volunteers needed for this research?
"The clinicaltrials.gov website says that this research is looking for more participants. The study was first announced on March 6th, 2019 and the most recent update was November 18th, 2021. They are trying to enroll 30 individuals total from 3 different locations."
Answered by AI
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