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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 below

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My condition is Stage II endometrial cancer with cervical involvement.

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My nerve damage is mild or not noticeable.

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My endometrial cancer is at a specific stage and type, according to FIGO 2009.

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I have had a hysterectomy.

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I am over 18 and have 3 risk factors.

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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:

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I have had or currently have lung inflammation treated with steroids.

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I have been treated with specific immune therapy for cancer.

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My cancer has come back after treatment.

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I have cancer that has spread to my brain or spinal cord.

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I have been diagnosed with HIV.

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I have had radiation therapy in my pelvis or abdomen before.

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I have an active tuberculosis infection.

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I have an autoimmune disease treated with strong medication in the last 2 years.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 • NCT03040999

64%

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

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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

0 / 15Eligibility criteria met