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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.
Must not have
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had or currently have lung inflammation treated with steroids.
Select...
I have been treated with specific immune therapy for cancer.
Select...
My cancer has come back after treatment.
Select...
I have cancer that has spread to my brain or spinal cord.
Select...
I have been diagnosed with HIV.
Select...
I have had radiation therapy in my pelvis or abdomen before.
Select...
I have an active tuberculosis infection.
Select...
I have an autoimmune disease treated with strong medication in the last 2 years.
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patients completing three cycles
Secondary study objectives
Frequency of adverse events
Overall survival
progression free survival
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
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.
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
473 Previous Clinical Trials
93,641 Total Patients Enrolled
6 Trials studying Endometrial Cancer
301 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,004 Previous Clinical Trials
5,185,360 Total Patients Enrolled
21 Trials studying Endometrial Cancer
4,825 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.
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