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PARP Inhibitor
Pembrolizumab + Olaparib for Cervical Cancer
Phase 2
Waitlist Available
Led By John P. Diaz, MD
Research Sponsored by John Diaz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed prior to the first dose of treatment.
Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment. Before patients can be enrolled, they must have normal laboratory values as outlined in Table 1. Labs must also fall within normal limits prior to infusion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs for patients with advanced or recurrent cervical cancer.
Who is the study for?
This trial is for women aged 18+ with advanced or recurrent cervical cancer who've had ≤2 chemo treatments. They must not be pregnant, breastfeeding, and if of childbearing potential, agree to contraception. Participants need a life expectancy ≥16 weeks and adequate organ function as per specific criteria.Check my eligibility
What is being tested?
The study tests the combination of pembrolizumab (an immunotherapy drug) and olaparib (a targeted therapy drug) in patients with cervical cancer that has returned or spread after standard chemotherapy. It's an open-label phase II trial where all participants receive the drugs.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, nausea, blood count changes increasing infection risk. Specific side effects from each drug may vary based on individual patient response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My recent lab tests show my organs are functioning well.
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I can carry out all my daily activities without help.
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My cervical cancer has come back and cannot be cured with just surgery or radiation.
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I am a woman over 18 with a confirmed diagnosis of cervical cancer.
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I have provided a sample of my tumor for testing.
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I am a woman over 18 with a confirmed diagnosis of cervical cancer.
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I am a female with cervical cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immune overall response rate
Secondary outcome measures
Duration of response
Therapeutic procedure
Number of patients with baseline tumor deficiencies
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
olaparib
2009
Completed Phase 3
~690
Find a Location
Who is running the clinical trial?
John DiazLead Sponsor
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,823 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,075 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had up to 2 chemotherapy treatments before.You have a mental health condition or substance abuse problem that affects your ability to follow the trial requirements.My cancer can be measured by scans and has grown in previously treated areas.I have been treated with specific immune therapy drugs before.I have not received a whole blood transfusion in the last 4 months.I am fully active or restricted in physically strenuous activity but can do light work.I am not able to have children or I agree to follow the birth control advice if I can.I am a woman of childbearing potential and not pregnant.I have had up to 2 chemotherapy treatments before.I had radiotherapy less than 2 weeks before starting the study treatment.You or your legal representative agree to the rules and restrictions laid out in the informed consent form (ICF) and the trial protocol.My recent lab tests show my organs are functioning well.I don't have any health issues that could affect the study's results or my participation.I have a serious health condition that is not under control.I haven't had cancer treatment in the last 4 weeks.I have not needed treatment for an autoimmune disease in the last 2 years.I have been diagnosed with HIV.I can carry out all my daily activities without help.I have not had major surgery in the last 2 weeks.I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.My cervical cancer has come back and cannot be cured with just surgery or radiation.I am a woman over 18 with a confirmed diagnosis of cervical cancer.I have had pneumonitis treated with steroids or have it now.I have provided a sample of my tumor for testing.I am a woman over 18 with a confirmed diagnosis of cervical cancer.I have provided a recent or past biopsy of my tumor that was not treated with radiation.I am not taking strong or moderate drugs that affect enzyme CYP3A.I have not received a live vaccine in the last 30 days.I cannot swallow pills or have a stomach condition that affects medication absorption.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I am a female with cervical cancer.I am currently on medication for an infection.My organs are functioning well.I have active brain metastases or cancer in the lining of my brain.I have a history of Hepatitis B or currently have Hepatitis C.I have an active tuberculosis infection.I have long-lasting side effects from cancer treatment that are moderate or worse.I have had a transplant of tissue, organ, or bone marrow from another person.You are expected to live for at least four months.I had another cancer but was treated successfully and have been cancer-free for over 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
Are there any openings to join this medical experiment?
"According to the data on clinicaltrials.gov, this research is currently open for enrolment and was initially posted in December of 2020 with a most recent update taking place in November 2022."
Answered by AI
What is the cap on enrollees for this clinical investigation?
"Correct. Clinicaltrials.gov offers evidence that this experiment, initially posted on December 3rd 2020, is currently recruiting subjects. At present, 48 individuals must be enlisted between 2 sites."
Answered by AI
Has pembrolizumab been tested in other clinical trials previously?
"Currently, 1114 investigations regarding pembrolizumab are underway with 143 in the third and final stage of a clinical trial. The most significant number of studies for this medication is located in Houston, Texas while there are 42747 total sites operating trials."
Answered by AI
Is this a pioneering clinical trial?
"According to the research available, 1114 trials for pembrolizumab have already been conducted in 66 countries and 3058 cities. The inaugural investigation into this medication took place 15 years ago in 2005; it was sponsored by AstraZeneca, included 98 participants, and successfully moved through Phase 1 drug approval. Since then, 313 studies involving this treatment have concluded their work."
Answered by AI
Has the Federal Drug Administration granted authorization for pembrolizumab?
"Due to the presence of clinical evidence indicating safety, pembrolizumab was assigned a score of 2 on our risk assessment scale. No efficacy data is currently available since this trial is in Phase 2."
Answered by AI
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