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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Immune overall response rate
Secondary outcome measures
Duration of response
Therapeutic procedure
Number of patients with baseline tumor deficiencies
+1 more

Trial 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
50 Previous Clinical Trials
7,861 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,901 Previous Clinical Trials
5,063,183 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04483544 — Phase 2
Cervical Cancer Research Study Groups: Treatment
Cervical Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04483544 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04483544 — Phase 2

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

To what ailments is pembrolizumab frequently administered?

"Patients with unresectable melanoma, microsatellite instability high ratings, and a heightened risk of recurrence can all be treated with pembrolizumab."

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
~5 spots leftby Nov 2030