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Alkylating agents
Immunotherapy + Radiation + Chemotherapy for Endometrial Cancer (FIERCE Trial)
Phase 1
Recruiting
Led By Kathleen Moore, MD, PhD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors.
Neuropathy (sensory and motor) ≤ Grade 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
FIERCE Trial Summary
This trial is testing whether a combination of pembrolizumab and radiation therapy followed by three cycles of pembrolizumab and chemotherapy is feasible in patients with endometrial cancer.
Who is the study for?
This trial is for adults over 18 with high-risk endometrial cancer, who've had a hysterectomy (removal of the uterus), and possibly other surgeries like removal of ovaries or lymph nodes. They should not have received recent cancer treatments, live vaccines, or have active infections. People with certain serious health conditions or those pregnant are excluded.Check my eligibility
What is being tested?
The study tests pembrolizumab (an immunotherapy drug) combined with vaginal cuff brachytherapy (targeted radiation therapy) followed by chemotherapy using paclitaxel and carboplatin in patients with high-risk endometrial cancer to see if this approach is effective.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in organs, skin reactions, fatigue, and flu-like symptoms. Chemotherapy can lead to nausea, hair loss, nerve damage and increased risk of infection. Radiation might result in localized discomfort or skin changes.
FIERCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is Stage II endometrial cancer with cervical involvement.
Select...
My nerve damage is mild or not noticeable.
Select...
My endometrial cancer is at a specific stage and type, according to FIGO 2009.
Select...
I have had a hysterectomy.
Select...
I am over 18 and have 3 risk factors.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
FIERCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients completing three cycles
Secondary outcome measures
Frequency of adverse events
Overall survival
progression free survival
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
FIERCE Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Radiation Therapy + Pembrolizumab/ChemotherapyExperimental Treatment4 Interventions
Pembrolizumab given 7 days prior to radiation therapy (e.g., vaginal cuff brachytherapy) followed by three cycles pembrolizumab combined with Carboplatin/Paclitaxel chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,573 Total Patients Enrolled
6 Trials studying Endometrial Cancer
301 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,895 Total Patients Enrolled
19 Trials studying Endometrial Cancer
4,103 Patients Enrolled for Endometrial Cancer
Kathleen Moore, MD, PhDPrincipal InvestigatorStephenson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is Stage II endometrial cancer with cervical involvement.I have had or currently have lung inflammation treated with steroids.My nerve damage is mild or not noticeable.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have not received a live vaccine in the last 30 days.I have been treated with specific immune therapy for cancer.I have an infection that needs treatment with medication.I've had a CT/MRI showing no signs of cancer spread because I didn't have certain surgeries.I have another cancer besides skin or in situ cancers that needed treatment in the last 3 years.My endometrial cancer is at a specific stage and type, according to FIGO 2009.I have had a hysterectomy.I am over 18 and have 3 risk factors.My organs are functioning well.My cancer has come back after treatment.I had radiotherapy over 2 weeks ago, have no side effects, and didn't need steroids.My cancer is in the early stages and is either serous or clear cell type.I have cancer that has spread to my brain or spinal cord.I have been diagnosed with HIV.I have had radiation therapy in my pelvis or abdomen before.I haven't had cancer treatment or experimental drugs in the last 4 weeks.It has been more than 12 weeks since my surgery.My cancer is aggressive or has spread to nearby vessels or deep into the muscle.You have had an allergic reaction to any part of the study treatments and had to stop taking them.I have an active tuberculosis infection.I may consider having surgery to remove lymph nodes in my pelvis and around my aorta.I have an autoimmune disease treated with strong medication in the last 2 years.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a recent biopsy confirming my cancer diagnosis.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Radiation Therapy + Pembrolizumab/Chemotherapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
What medical conditions typically receive treatment with Pembrolizumab?
"Pembrolizumab can be used to treat a variety of malignant neoplasms, ranging from unresectable melanoma to microsatellite instability high and cases with an elevated risk for recurrences."
Answered by AI
Is recruitment for this experiment still active?
"Affirmative. Clinicaltrials.gov has verified that the recruitment process for this trial started on February 19th 2020 and was last changed on August 9th 2022, with 40 individuals sought from a single location."
Answered by AI
Is there a body of research around the effectiveness of Pembrolizumab?
"At present, there are 1990 clinical trials investigating the efficacy of pembrolizumab. Of these active studies, 413 have reached Phase 3. Shanghai is by far the most popular location for such research; however, it can also be found in 91 other cities across the globe."
Answered by AI
What is the current enrollment of participants in this experiment?
"Affirmative. Clinicaltrials.gov states that this clinical trial, posted on February 19th 2020 and recently edited August 9th 2022, is actively seeking participants with 40 individuals needed from a single site."
Answered by AI
What potential risks may be associated with Pembrolizumab?
"The safety of Pembrolizumab, which is currently undergoing Phase 1 trials with limited evidence supporting its efficacy and security, received a score of 1 from our team at Power."
Answered by AI
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