REGN4018 Alone or Combined With Cemiplimab in Ovarian Cancer Patients
Research type
Research Study
Full title
A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer
IRAS ID
274096
Contact name
Susana Banerjee
Contact email
Sponsor organisation
Regeneron Pharmaceuticals Inc.
Eudract number
2019-003298-24
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
134785, IND Number; 274096, UK IRAS ID; 44339, UK CPMS number
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
REGN4018 and cemiplimab are the study drugs under investigation for the treatment of ovarian cancer. They are both investigational drugs, meaning they have not received approval from health authorities for the treatment of ovarian cancer.
The purpose of this study is to learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or with cemiplimab to patients with ovarian cancer, without causing too many side effects. The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well the body can remove the study drug/s.
Up to 50 participants may be treated with REGN4018 alone and another 50 participants may be treated with REGN4018 in combination with cemiplimab.
This study consists of:
• A screening period of up to 28 days
• A treatment period which will differ in length between participants. Participants will be able to receive treatment until one of the following happens;
- their cancer gets worse, and/or another anti-cancer drug is initiated.
- they experience a side effect that is considered too serious to keep getting the study drug/s and/or
- the participant/study doctor decides that they should stop taking the study drug/s
• A follow-up period at 30 and 90 days after treatment.If treatment is stopped because of a complete response, or because the study doctor decides they should stop taking study drug/s for reasons other than the disease getting worse or starting other anti-cancer drugs, participants will be asked to come to the clinic for follow-up visits every 3 weeks for up to 24 weeks.
Participants will be given the study drug/s through a vein (IV infusion). REGN4018 will be given once a week and cemplimimab will be given once every 3 weeks.
Informed consent must be obtained from each participant before any study-related tests or procedures are performed. At scheduled study visits, participants will visit the research centre where study assessments will take place e.g. physical exam, vital signs, blood and urine tests, biopsies, body scans and questionnaires.
Side effects will be monitored throughout the study.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0331
Date of REC Opinion
13 Jan 2021
REC opinion
Further Information Favourable Opinion