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Checkpoint Inhibitor
Pembrolizumab for Cervical Dysplasia
Phase 2
Recruiting
Led By John A Glaspy, MD
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
Female participants who are at least 21 years of age on the day of signing informed consent with active (not yet resected), histologically confirmed diagnosis of CIN grade 2 or 3 or carcinoma in situ (without invasive component) will be enrolled in this study. Subjects with multifocal disease are acceptable
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
Study Summary
This trial looks at how well immunotherapy with pembrolizumab works to treat cervical intraepithelial neoplasia.
Who is the study for?
Women over 21 with a confirmed diagnosis of CIN grade 2 or 3, or carcinoma in situ without invasive components. Participants must not be pregnant, breastfeeding, and should agree to contraceptive guidance post-treatment. They need normal organ function, an ECOG status of 0-1, and willingness to undergo biopsies and surgical procedures if not contraindicated.Check my eligibility
What is being tested?
The trial is testing the effectiveness of pembrolizumab on cervical intraepithelial neoplasia (CIN). Pembrolizumab is a monoclonal antibody that may boost the immune system's ability to fight cancer by preventing tumor growth and spread.See study design
What are the potential side effects?
Pembrolizumab can cause side effects such as fatigue, skin reactions, diarrhea, hormonal gland problems (like thyroid dysfunction), liver inflammation, lung issues like pneumonitis, infusion-related reactions and could potentially worsen autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 21 with a confirmed diagnosis of CIN 2/3 or carcinoma in situ.
Select...
I am fully active or can carry out light work.
Select...
I agree to have a LEEP or CKC surgery after 24 weeks of treatment, unless it's not safe for me then.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological response rate
Secondary outcome measures
Incidence of adverse events
Proportion of subjects with pathologic partial response (regression to a lower grade of dysplasia)
Other outcome measures
Assess percentage of subjects who respond to treatment who are HPV positive compared to percentage of subjects who respond to treatment who are HPV negative.
Assess percentage of subjects with initial HPV infection who clear HPV infection (using p16 positivity from pathology) as a surrogate response to treatment evaluation.
PD-L1 expression
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
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 4 cycles (24 weeks).
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?
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,687 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,070 Total Patients Enrolled
John A Glaspy, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or have it now.I have not received a live vaccine in the last 30 days.I had another cancer but have been cancer-free for 2 years after treatment.I have provided a recent or past biopsy sample of my tumor that was not treated with radiation.I am a woman over 21 with a confirmed diagnosis of CIN 2/3 or carcinoma in situ.I am not pregnant, not breastfeeding, and meet one of the specified conditions.I agree to a biopsy after 2 treatment cycles if my doctor thinks it's safe and possible.My recent tests show my organs are functioning normally.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have been treated with specific immune therapy drugs before.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am fully active or can carry out light work.I have received treatment for CIN within the last 4 weeks.I am currently being treated for an infection.I have an active tuberculosis infection.I have received an organ or tissue transplant from another person.I agree to have a LEEP or CKC surgery after 24 weeks of treatment, unless it's not safe for me then.
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.
Could you provide an outline of the research conducted on Pembrolizumab prior to this one?
"Currently, the research into Pembrolizumab encompasses 961 studies; of these, 122 are in Phase 3. Houston, Texas hosts a sizable portion of this data collection. On the other hand, 35731 sites around the globe have enrolled patients for trials with Pembrolizumab."
Answered by AI
Has the Food & Drug Administration greenlighted Pembrolizumab?
"Since this is a Phase 2 trial and there is not yet any evidence of efficacy, our team at Power rated the safety of Pembrolizumab as a 2."
Answered by AI
Is recruitment for this research currently underway?
"Affirmative. Details accessible on clinicaltrials.gov demonstrate that this experiment, initiated June 30th 2021, is still searching for participants. 25 individuals are required from a single medical facility."
Answered by AI
What diseases or conditions can Pembrolizumab be utilized to combat?
"Pembrolizumab is a common treatment for malignant neoplasms, as well as unresectable melanoma, microsatellite instability high and post-chemotherapy disease progression."
Answered by AI
What is the aggregate quantity of participants in this medical experiment?
"Affirmative. Details hosted on clinicaltrials.gov confirm that this investigation, which was initially announced on June 30th 2021, is looking for participants. 25 individuals need to be recruited from one medical centre."
Answered by AI
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