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Immunotherapy + Chemotherapy for Cervical Cancer
Study Summary
This trial is testing whether the immunotherapy drug pembrolizumab, when combined with standard chemotherapy, is more effective at treating cervical cancer than chemotherapy alone. The study will also look at the safety of the two treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I have not had active treatment for another cancer, except for certain skin or in situ cancers, in the last 3 years.My cervical cancer cannot be cured with surgery or radiation and hasn't been treated with chemotherapy.I am not pregnant or breastfeeding and if I can have children, I agree to use birth control during and after treatment.I have received an organ or tissue transplant from another person.I have had or currently have lung inflammation treated with steroids.I had radiotherapy over 2 weeks ago and have no side effects needing steroids.I am currently being treated for an infection.I have a history of Hepatitis B or active Hepatitis C.I am still recovering from major surgery complications.I have not received a live vaccine in the last 30 days.I am allergic or cannot take cisplatin, carboplatin, paclitaxel, or bevacizumab.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have been diagnosed with HIV.I have been treated with specific immune therapy before.I have stable brain metastases that have been treated, but not with chemotherapy.I completed chemotherapy used to enhance radiation effects over 2 weeks ago with no lingering side effects.I have had chemotherapy for cervical cancer before.My organs are functioning well.I have provided a sample of my tumor for PD-L1 status testing.I have an active tuberculosis infection.My cancer can be measured by scans.I am fully active or restricted in physically strenuous activity but can do light work.I have mild nerve pain or hair loss.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
- Group 1: Pembrolizumab+Chemotherapy
- Group 2: Placebo+Chemotherapy
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What are the primary conditions that Pembrolizumab is used to treat?
"Pembrolizumab is used to fight disease and can be effective in treating hodgkin disease, metastatic cutaneous squamous cell carcinoma, and melanoma."
Are there any current openings for volunteers in this clinical research?
"This study is not currently recruiting patients. The clinical trial was first posted on October 25th, 2018 and updated as recently as October 19th, 2022. There are 410 other trials searching for participants with uterine cervical neoplasms and 2673 studies for Pembrolizumab actively enrolling participants."
What other medical research has been conducted with Pembrolizumab?
"Pembrolizumab's origins can be traced back to City of Hope Comprehensive Cancer Center in 1997. Since then, there have been 3253 completed trials and 2673 active ones. Many of the latter are based out of Orange, California."
What are the researchers hoping to achieve with this clinical trial?
"According to the sponsor of this clinical trial, Merck Sharp & Dohme Corp., the primary outcome being measured over a period of up to approximately 2 years is progression-free survival (PFS) per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) as assessed by an investigator. In addition to the primary outcome, this study will be assessing secondary outcomes including the number of participants who experience an immune-related adverse event (irAE). An irAE is defined as an AE that may occur shortly after the first dose or several months after the last dose of pembrolizumab"
How many different medical clinics are conducting this study?
"Currently, there are a total of 35 clinical trial sites recruiting for this study. In North America, these locations include UC Irvine Health ( Site 1796) in Orange, H. Lee Moffitt Cancer Center and Research Institute ( Site 1754) in Tampa, and CIUSSS du Saguenay-Lac-St-Jean ( Site 1729) in Chicoutimi."
Is Pembrolizumab generally well-tolerated by patients?
"Pembrolizumab has received a score of 3 for safety. This is because it is in Phase 3, which suggests that there is efficacy data as well as multiple rounds of safety data."
How many individuals are being asked to participate in this research project?
"At this time, individuals cannot join this trial as it is not recruiting patients. Although, this study was first posted on October 25th 2018 and updated recently on October 19th 2020. If you are interested in participating in other trials, there are 410 clinical trials for uterine cervical neoplasms and 2673 studies involving Pembrolizumab that are currently admitting participants."
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