CC-90011-ST-002 Phase 2 of CC-90011 and nivolumab in advanced cancers
Research type
Research Study
Full title
A PHASE 2, MULTICENTER, OPEN-LABEL, MULTI-COHORT STUDY TO ASSESS SAFETY AND EFFICACY OF CC-90011 IN COMBINATION WITH NIVOLUMABIN SUBJECTS WITH ADVANCED CANCERS
IRAS ID
278609
Contact name
Sanjaykumar Popat
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2019-004194-95
Clinicaltrials.gov Identifier
44704, NIHR
Duration of Study in the UK
3 years, 5 months, 16 days
Research summary
The purpose of this study is to see if the experimental drug CC-90011 in combination with nivolumab, an immune checkpoint inhibitor, is safe and effective in patients with SCLC and sqNSCLC. The purpose is also to see if CC-90011 in combination with nivolumab is effective in preventing the participant’s disease from coming back or in controlling their disease.
CC-90011 is an investigational medicine. CC-90011 works by blocking LSD1, an enzyme (molecule that drives chemical reaction) in the body that is involved in regulating some genes that are important for cancer progression and cell growth. Nivolumab is a monocloncal antibody and is designed to trigger the body’s own immune system to destroy tumours and has been approved in a variety of cancers such as metastatic melanoma, advanced lung cancer, and kidney cancer. Nivolumab has not been approved for the treatment of cancers outlined in this study and its use in this study is investigational.
About 135 participants worldwide will take part in the study, with about 20 participants from the UK. The study length is estimated to be about 36 months with participants receiving treatment for up to two years. Participants who will take part will have received one or two prior lines of cancer therapy that included standard care platinum-based therapy, with or without an immune checkpoint inhibitor.
Participation is voluntary and participants will be recruited to three groups, depending on their disease type and the type of treatment they have received in the past. All cohorts will receive CC-90011 once weekly by mouth and nivolumab by IV infusion once every four weeks. Participants will also undergo a number of health checks and tests, such a scans, blood tests and biopsies, to determine first if they are able to participate and throughout the study to monitor their disease progression.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0452
Date of REC Opinion
20 May 2020
REC opinion
Further Information Favourable Opinion