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pembrolizumab for Cervical Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Miami Cancer Institute at Plantation, Plantation, FLCervical Cancer+1 Morepembrolizumab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing a new combination of drugs for patients with advanced or recurrent cervical cancer.

Eligible Conditions
  • Cervical Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
HB-201 IT
1
NEO-201 in combination with pembrolizumab
1
HB-201 intravenous administration + standard of care regimen including pembrolizumab.

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 3 years

3 years
Duration of response
Immune overall response rate
Therapeutic procedure
Progression Free Survival
baseline
Number of patients with baseline tumor deficiencies

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
HB-201 IT
1
NEO-201 in combination with pembrolizumab
1
HB-201 intravenous administration + standard of care regimen including pembrolizumab.

Trial Design

1 Treatment Group

Treatment
1 of 1

Experimental Treatment

48 Total Participants · 1 Treatment Group

Primary Treatment: pembrolizumab · No Placebo Group · Phase 2

TreatmentExperimental Group · 2 Interventions: pembrolizumab, olaparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor
45 Previous Clinical Trials
7,835 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,707 Previous Clinical Trials
4,964,158 Total Patients Enrolled
Florida Department of HealthOTHER_GOV
24 Previous Clinical Trials
12,293 Total Patients Enrolled
John P. Diaz, MDPrincipal InvestigatorMiami Cancer Institute at Baptist Health Inc.

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This study is only for women who have cervical cancer. Men cannot participate.
Women aged 18 years or older with confirmed cervical cancer are eligible for the study.
You may have received a maximum of two rounds of chemotherapy treatments in the past. Radiation therapy using platinum sensitizing agents is counted as a chemotherapy regimen.
You have a measurable disease, meaning that your illness can be quantified using a specific set of guidelines called RECIST 1.1. If you have tumors in an area of your body that has already been treated with radiation, they can still be measured if they have grown since the treatment.
You are not able to become pregnant OR if you are a woman who can become pregnant, you agree to use birth control during the treatment period and for at least 120 days after the last dose of 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.
You have to give a sample of your tumor tissue that has not been treated with radiation before. The preferred sample is a block of tissue that has been preserved in formalin and paraffin. If possible, a new biopsy should be taken for the study.
Your organs must be working properly before you can join the study. A blood test will be done to make sure your organ function is normal. The blood test must be done within 10 days before the study treatment starts. The results of the blood test must be within normal limits before you can start the treatment.
You are able to perform daily activities without difficulty or with slight limitations due to your medical condition.
You are expected to live for at least four months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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