EMPOWER Cervical 1
Research type
Research Study
Full title
An open-label, randomized, phase 3 clinical trial of REGN2810 versus investigator’s choice of chemotherapy in recurrent or metastatic cervical carcinoma
IRAS ID
253082
Contact name
Azmat Hassan Sadozye
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2017-000350-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
133224, IND Number
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
Research Summary
This is an open-label, randomised, multi-center, phase 3 trial comparing REGN2810 (cemiplimab) versus chemotherapy of Investigators Choice(IC) in patients with recurrent or metastatic cervical cancer. \nApproximately 436 patients, will be randomised to either the experimental REGN2810 (cemiplimab) treatment arm or the IC of chemotherapy control treatment arm.\nThe duration of the study treatment period is up to 96 weeks (up to 16 cycles of 6 weeks each), excluding the screening period. The follow-up period continues until death or study completion.\nThe study includes 3 periods, screening, treatment and follow up\nscreening - 28 days\nTreatment period - 96 weeks\nfollow up - 4 months\nSurvival follow up - Once treatment and follow up is complete participants will be contacted every 3 months (quarterly) for information regarding their disease status if they are receiving any other cancer treatments. Participation in survival follow-up will last death or study termination by sponsor
Summary of results
Overview of this study
Why was the research needed?
o Researchers are looking for a different way to treat cervical cancer in adults. Before a treatment is available to all people, researchers study the treatment to learn more about it.What treatments did the participants receive?
o The participants in this study received either cemiplimab or their doctor’s choice of chemotherapy drug. The chemotherapy drugs that the study doctors could choose from were pemetrexed, topotecan, irinotecan, gemcitabine, and vinorelbine.What were the results of this study?
The main questions the researchers wanted to answer in this study were:
o How long did the participants live after joining this study?
For the participants who received cemiplimab, the median amount of time they lived after joining the study was 11.7 months.
For the participants who received chemotherapy, the median amount of time they lived after joining the study was 8.5 months.
The median is the middle number in a set of numbers when ordered from lowest to highest.
Overall, the researchers found that the participants who received cemiplimab lived longer after joining the study compared with the participants who received chemotherapy.o Did the treatments potentially cause any unwanted health effects during this study?
There were 57.3% of participants who had unwanted health effects that were potentially caused by cemiplimab during this study. This was 172 out of 300 participants.
There were 81.7% of participants who had unwanted health effects that were potentially caused by chemotherapy during this study. This was 237 out of 290 participants.
More details about the results of this study are included later in this summary.
Where can I learn more about this study?
You can find more information about this study on the websites listed on the last page.Who took part in this study?
The researchers asked for the help of people with cervical cancer. The participants in this study were all females who were 22 to 87 years old when they joined.
The participants could join this study if:
• They were diagnosed with cervical cancer that had come back after treatment (recurrent), would not go away with treatment (persistent), or had spread to other parts of the body (metastatic).
• They had been treated with a cancer therapy called platinum-based chemotherapy, but their cancer had gotten worse or had come back.
• They did not have any standard treatment options available to try to cure their cervical cancer.
• Their cervical cancer tumors were big enough to be measured.
• They were able to do most of their normal daily activities and were expected to live for at least 12 weeks after they joined the study.
The study included 608 participants in 14 countries:
Country Number of participants Country Number of participants
Australia 30 Poland 45
Belgium 15 Russia 85
Brazil 89 South Korea 76
Canada 42 Spain 66
Greece 9 Taiwan 34
Italy 35 The United Kingdom 2
Japan 56 The United States 24Why was the research needed?
Researchers are looking for a different way to treat cervical cancer. Before a treatment is available to all patients, researchers study the treatment to learn more about it.
In people with cervical cancer, the body is not able to control the growth of some cells in the cervix, which is part of the female reproductive system. These extra cells can form tumors, which can affect the normal function of organs in the body. Over time, these tumors can spread to other parts of the body and cause further harm.
The participants in this study had cervical cancer that was recurrent, persistent, or metastatic. Recurrent means that the cancer has come back after receiving a previous treatment. Persistent means that the cancer does not go away with treatment. Metastatic means that the cancer has spread from the cervix to other parts of the body, including parts far away from the cervix.There are treatments available for people with cervical cancer. But, for many people, their cervical cancer will come back or get worse after these treatments. For some people, these treatments may not work at all.
The study treatment cemiplimab is designed to help treat cancer by stopping a protein called PD-1 from working. Stopping this protein from working helps the immune system to attack the cancer cells and stop them from growing out of control. Cemiplimab is already approved in some countries to treat people with certain other types of cancer.
In this study, the researchers wanted to learn if cemiplimab can help people with cervical cancer, and how it compares to certain chemotherapy drugs.What was the purpose of this study?
The researchers in this study wanted to learn how cemiplimab works in a large number of participants with cervical cancer, compared to certain chemotherapy drugs. They also wanted to find out if the participants had any unwanted health effects during the study.
The main questions the researchers wanted to answer in this study were:
• How long did the participants live after joining this study?
• Did the treatments potentially cause any unwanted health effects during this study?
The answers to these questions are important to know before other studies can be done that help find out if cemiplimab helps improve the health of people with cervical cancer.What treatments did the participants receive?
The participants in this study received either cemiplimab or their doctor’s choice of chemotherapy drug. The chemotherapy drugs that the study doctors could choose from were pemetrexed, topotecan, irinotecan, gemcitabine, and vinorelbine.
In this summary, “study treatment†means anything the participants received as a part of the study. This includes cemiplimab, pemetrexed, topotecan, irinotecan, gemcitabine, and vinorelbine. Cemiplimab is the treatment that the researchers wanted to learn more about.This study had 2 groups. The participants in Group 1 received cemiplimab. The participants in Group 2 received chemotherapy. The participants in Group 2 received pemetrexed, topotecan, irinotecan, gemcitabine, or vinorelbine.
This was an open label study. This means each participant knew what they were receiving, and the doctors and study staff also knew.
The researchers used a computer program to randomly choose whether each participant received cemiplimab or chemotherapy. This helped make sure the treatments were chosen fairly and comparing the results of the treatments was as accurate as possible.
The participants who received pemetrexed were also given some vitamins alongside their treatment. This is called vitamin supplementation. In this study, the vitamin supplementation alongside pemetrexed was folic acid and vitamin B12. The participants receiving pemetrexed may also have received a drug called a corticosteroid. These were all given to try and reduce some of the side effects of pemetrexed.
The doses of cemiplimab were measured in milligrams (mg).
The doses of chemotherapy were measured in milligrams per meter squared (mg/m2). This is a way of giving a dose of a treatment based on a person’s body size.The chart below shows the treatments that the participants received.
Group 1 Group 2
Group Cemiplimab ChemotherapyParticipants 304 participants 304 participants
Dose 350 mg of cemiplimab 500 mg/m2 of
pemetrexed
1 mg/m2 of topotecan
100 mg/m2 of irinotecan
1,000 mg/m2 of gemcitabine
30 mg/m2 of vinorelbineTreatment Through a needle directly into a vein over a
period of time (IV infusion)Cycles Once every 3 weeks Once every 3 weeks
Once a day for 5 days every 3 weeks
Once a week for 4 weeks, then 10
to 14 days of no treatment, and then repeated
Once a week for 2 weeks, then 1 week of no
treatment, and then repeated
Once a week for 2 weeks, then 1 week of no
treatment, and then repeatedDuration Up to 96 weeks Up to 96 weeks
For the participants who received topotecan, their dose of treatment could be increased to 1.25 mg/m2 if the study doctors thought it was safe. For the participants who received
irinotecan, their dose of treatment could be increased to 125 mg/m2 if the study doctors thought it was safe.Some participants who received chemotherapy were allowed to start receiving cemiplimab for 6 weeks if their cancer got worse while receiving chemotherapy.
Some participants who received cemiplimab were allowed to continue receiving cemiplimab for another 6 weeks after the 96-week period was over. This is known as an extension phase. This was allowed if their cancer got worse after they stopped receiving cemiplimab at 96 weeks.
REC name
Wales REC 3
REC reference
18/WA/0412
Date of REC Opinion
29 Jan 2019
REC opinion
Further Information Favourable Opinion