Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer (FIERCE)
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|ClinicalTrials.gov Identifier: NCT03932409|
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Pembrolizumab Radiation: Radiation Therapy||Phase 1|
Before the patient begins the study:
Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of the ovaries, and removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning.
Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care. Tumor tissue will need to be collected for study tests to see if the patient is eligible for to take part on the study.
TREATMENT If the patient is eligible, pembrolizumab will be given 7 days before radiation therapy. After radiation therapy, three cycles of pembrolizumab and chemotherapy will be given.
Study participation will be up to two years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Trial of Vaginal Cuff Brachytherapy + Pembrolizumab (MK3475) Followed by 3 Cycles of Dose Dense Paclitaxel/q 21 Day Carboplatin + Pembrolizumab (MK3475) in High Intermediate Risk Endometrial Cancer|
|Actual Study Start Date :||February 19, 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2023|
Experimental: Pembrolizumab + Radiation Therapy
Pembrolizumab given 7 days prior to radiation therapy (e.g., vaginal cuff brachytherapy)
200mg IV given the week (7 days) prior to radiation initiation
Other Name: MK3475
Radiation: Radiation Therapy
- Proportion of patients completing three cycles [ Time Frame: 36 months ]defined as completion of 3 cycles of pembrolizumab combined with dose dense paclitaxel and carboplatin chemotherapy
- progression free survival [ Time Frame: up to 3 years ]time from study entry to the first tumor progression
- progression free survival [ Time Frame: 6 months ]progression free survival rate at 6 months
- Overall survival [ Time Frame: up to 3 years ]time from study entry to death
- Frequency of adverse events [ Time Frame: up to 3 years ]frequency and severity of adverse events as assessed by the CTCAE v5
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932409
|Contact: Lead Gyn Nurse||1-405-271-8777||SCC-IIT-Office@ouhsc.edu|
|United States, Oklahoma|
|Stephenson Cancer Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Lead Gyn Nurse 405-271-8777 SCC-IIT-Office@ouhsc.edu|
|Principal Investigator: Lisa Landrum, MD, PhD|
|Principal Investigator:||Lisa Landrum, MD, PhD||Stephenson Cancer Center|