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Alkylating agents
Pembrolizumab + Chemoradiotherapy for Cervical Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment
Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the local site investigator/radiology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 46 months
Awards & highlights
Study Summary
This trial will compare the effectiveness of two cancer treatments for locally advanced cervical cancer. The first treatment is pembrolizumab plus concurrent chemoradiotherapy and the second is placebo plus concurrent chemoradiotherapy. The study's primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.
Who is the study for?
This trial is for women with high-risk locally advanced cervical cancer stages IB2-IIB (node-positive) or III-IVA. They must have certain types of cervical cancer, not have had previous treatments for it, and be immunotherapy-naïve. Participants should be in good health overall, not pregnant or breastfeeding, willing to use contraception, and able to provide a tissue sample.Check my eligibility
What is being tested?
The study tests if adding pembrolizumab (an immunotherapy drug) to standard chemoradiotherapy improves survival compared to using a placebo with the same chemotherapy and radiation treatment in patients with advanced cervical cancer. The main goal is seeing if the disease progresses more slowly or people live longer with pembrolizumab.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in various organs, fatigue, infusion reactions similar to allergic responses during drug administration, skin rash, hormone gland problems (like thyroid dysfunction), and can increase infection risk.
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.
Select...
My cancer can be seen and measured on scans.
Select...
My cervical cancer is advanced but has not spread beyond the pelvic area.
Select...
I have provided a tissue sample from my tumor for testing.
Select...
My cervical cancer is confirmed as squamous, adenocarcinoma, or adenosquamous.
Select...
I have not had surgery, radiation, or any treatment for cervical cancer before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 46 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 46 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
Secondary outcome measures
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
+15 moreSide 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
2Treatment groups
Experimental Treatment
Group I: chemoradiotherapy + placebo for pembrolizumabExperimental Treatment4 Interventions
Participants receive placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Group II: chemoradiotherapy + pembrolizumabExperimental Treatment4 Interventions
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
Brachytherapy
2007
Completed Phase 3
~2100
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,155 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,058,955 Total Patients Enrolled
GOG FoundationNETWORK
42 Previous Clinical Trials
15,761 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take cisplatin due to health reasons.My organs are functioning well enough for treatment.My cancer has spread to areas above my lower back or in the groin.I have been diagnosed with HIV.I have been treated for an autoimmune disease in the last 2 years.I have received an organ or tissue transplant from another person.I have been treated with specific immune therapy drugs before.I have another cancer that is getting worse or was treated in the last 3 years.I have not had cancer treatment or been in a trial for cancer drugs in the last 4 weeks.I haven't taken any immune-boosting drugs in the last 6 weeks or before their effects wore off.I am fully active or restricted in physically strenuous activity but can do light work.I have or had lung inflammation that needed steroids.My cancer can be seen and measured on scans.My cervical cancer is advanced but has not spread beyond the pelvic area.I have provided a tissue sample from my tumor for testing.I have not received a live vaccine in the last 30 days.I am not pregnant or breastfeeding and agree to use effective birth control and not donate or store eggs for 120-180 days after treatment.My condition is at the most advanced stage of gynecological cancer.I have had my uterus removed or will have it removed as part of my initial cervical cancer treatment.I am not pregnant or breastfeeding and agree to use effective birth control during and after treatment.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have swelling in both kidneys, but one side is treated or not severe.My cervical cancer is confirmed as squamous, adenocarcinoma, or adenosquamous.I am currently being treated for an infection.My cancer is not a subtype of LACC.My condition or tumor shape makes certain radiation treatments impossible.I have a history of Hepatitis B or active Hepatitis C.I have not had surgery, radiation, or any treatment for cervical cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: chemoradiotherapy + placebo for pembrolizumab
- Group 2: chemoradiotherapy + pembrolizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Pembrolizumab has been FDA approved - could you please tell us more about its safety profile?
"Pembrolizumab's safety is supported by efficacy data from Phase 3 trials, so it received a score of 3."
Answered by AI
Are recruitment efforts ongoing for this research project?
"That is correct. The clinical trial in question, which was first announced on May 12th 2020, is still actively recruiting patients. 31 different medical centres are involved in the study, and 980 people are needed for the research to be conducted effectively."
Answered by AI
For what purpose is Pembrolizumab typically employed?
"Pembrolizumab is the standard of care for malignant neoplasms. In addition, Pembrolizumab can be used to ameliorate unresectable melanoma, microsatellite instability high, and high risk of recurrence."
Answered by AI
How many people are testing this new medication at most?
"That is correct, the online clinicaltrials.gov registry has this trial listed as open and currently recruiting patients. This specific research project was first made public on May 12th, 2020 with the most recent update being November 7th, 2022. In total, 980 individuals are needed for the study and recruitment will be taking place at 31 hospitals or clinics."
Answered by AI
In how many different locations are hospitals conducting this trial?
"At the moment, this clinical trial is taking place in 31 locations. Some of these cities include Columbus, Phoenix and Detroit. To try and make things more convenient for participants, it is best to select a location that is close to where you live."
Answered by AI
With what other drugs has Pembrolizumab been tested in medical trials?
"At the moment, there are 1619 ongoing studies exploring pembrolizumab. 365 of those are in Phase 3. Although a majority of the trials for pembrolizumab are based in Shanghai, there are 70339 locations worldwide running these sorts of investigations."
Answered by AI
What are the primary goals of this clinical experiment?
"This study will aim to improve Overall Survival (OS) rates, and will be monitored for up to 38 months. Additionally, the study's secondary objectives include ORR Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), and Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)."
Answered by AI
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