45 Participants Needed

Immunotherapy + Radiation + Chemotherapy for Endometrial Cancer

(FIERCE Trial)

Recruiting at 1 trial location
LG
Overseen ByLead Gyn Nurse
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this single arm, open label study is to evaluate the feasibility of pembrolizumab combined with radiation administered to the upper part of the vagina (vaginal cuff brachytherapy) followed by three cycles of pembrolizumab and chemotherapy in patients with endometrial cancer.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain treatments like systemic anti-cancer therapy, immunosuppressive therapy, or have received a live vaccine recently, you may need to stop or adjust those before joining. It's best to discuss your specific medications with the trial team.

Is the combination of immunotherapy, radiation, and chemotherapy safe for treating endometrial cancer?

Pembrolizumab (Keytruda), an immunotherapy drug, can cause pneumonitis (lung inflammation) in 1%-5% of patients, which is a serious side effect. Paclitaxel and carboplatin are standard chemotherapy drugs for endometrial cancer, and their safety profile is well-established, though they can have side effects like nausea and low blood counts. The safety of combining these treatments with radiation is still being studied, but each component has known safety data.12345

How is the drug combination of Carboplatin, Paclitaxel, and Pembrolizumab unique for treating endometrial cancer?

This treatment is unique because it combines standard chemotherapy drugs, Carboplatin and Paclitaxel, with Pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells. While the benefit of adding Pembrolizumab to chemotherapy for endometrial cancer is still unclear, it represents a novel approach by integrating immunotherapy with traditional chemotherapy.15678

What data supports the effectiveness of the drugs used in the Immunotherapy + Radiation + Chemotherapy for Endometrial Cancer trial?

Pembrolizumab (Keytruda) is approved for treating advanced endometrial cancer with specific genetic features, and paclitaxel plus carboplatin is the standard chemotherapy for advanced or recurrent endometrial cancer. However, the benefit of adding pembrolizumab to chemotherapy is still unclear.156910

Who Is on the Research Team?

Christina Washington MD

Christina Washington, MD

Principal Investigator

Stephenson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My condition is Stage II endometrial cancer with cervical involvement.
My nerve damage is mild or not noticeable.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial and authorization permitting release of personal health information.
See 9 more

Exclusion Criteria

I have had or currently have lung inflammation treated with steroids.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Pembrolizumab is given 7 days prior to radiation therapy (vaginal cuff brachytherapy)

1 week

Chemotherapy

Three cycles of pembrolizumab combined with Carboplatin/Paclitaxel chemotherapy

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Paclitaxel
  • Pembrolizumab
  • Vaginal cuff brachytherapy (VCB)
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Radiation Therapy + Pembrolizumab/ChemotherapyExperimental Treatment4 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

Pembrolizumab (Keytruda) is approved for treating advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, specifically for patients whose disease has progressed after previous treatments.
This approval is significant for patients who are not candidates for curative surgery or radiation, providing a new therapeutic option for a challenging stage of cancer.
New Approved Use for Keytruda.Aschenbrenner, DS.[2022]
In a review of three studies involving 1,431 patients, the addition of PD-1/PD-L1 inhibitors to standard chemotherapy (carboplatin and paclitaxel) significantly improved progression-free survival (PFS) and overall survival (OS) in patients with mismatch repair-deficient endometrial cancer.
However, this benefit was not observed in patients with mismatch repair-proficient tumors, indicating that the effectiveness of the combination therapy may depend on the specific genetic characteristics of the cancer.
PD-1/PD-L1 inhibitors plus carboplatin and paclitaxel compared with carboplatin and paclitaxel in primary advanced or recurrent endometrial cancer: a systematic review and meta-analysis of randomized clinical trials.de Moraes, FCA., Pasqualotto, E., Lopes, LM., et al.[2023]
In a study of 122 patients with high and intermediate-high risk endometrial cancer, those treated with a dose dense regimen of paclitaxel plus carboplatin showed a significantly higher three-year progression-free survival (79.5%) compared to those on the standard three-weekly protocol (57.4%).
The dose dense protocol also resulted in fewer progression events and distant metastases, along with improved overall survival in advanced stage cases, while experiencing fewer complaints of musculoskeletal pain compared to the standard treatment.
Dose dense carboplatin paclitaxel improves progression free survival in patients with endometrial cancer.Kogan, L., Laskov, I., Amajoud, Z., et al.[2022]

Citations

New Approved Use for Keytruda. [2022]
PD-1/PD-L1 inhibitors plus carboplatin and paclitaxel compared with carboplatin and paclitaxel in primary advanced or recurrent endometrial cancer: a systematic review and meta-analysis of randomized clinical trials. [2023]
Dose dense carboplatin paclitaxel improves progression free survival in patients with endometrial cancer. [2022]
Carboplatin and paclitaxel plus avelumab compared with carboplatin and paclitaxel in advanced or recurrent endometrial cancer (MITO END-3): a multicentre, open-label, randomised, controlled, phase 2 trial. [2023]
Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer. [2023]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Treatment with paclitaxel plus carboplatin, alone or with irradiation, of advanced or recurrent endometrial carcinoma. [2015]
Concurrent carboplatin/paclitaxel and intravaginal radiation in surgical stage I-II serous endometrial cancer. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A trial of outpatient paclitaxel and carboplatin for advanced, recurrent, and histologic high-risk endometrial carcinoma: preliminary report. [2016]
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