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Monoclonal Antibodies
Pembrolizumab for Recurrent Ovarian Cancer
Phase 2
Waitlist Available
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
Must not have
Has known history of, or any evidence of active, non-infectious pneumonitis
Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had lung inflammation not caused by an infection.
Select...
I have been diagnosed with HIV.
Select...
I have a history of active tuberculosis.
Select...
I am currently being treated for an infection.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Select...
I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate (ORR) assessed per immune related Response Evaluation Criteria in Solid Tumors (irRECIST)
Secondary study objectives
Progression-free survival (PFS) assessed per irRECIST
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~2810
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,001 Previous Clinical Trials
5,184,906 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,424 Patients Enrolled for Ovarian Cancer
Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,189 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.
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