A Phase 1b, Open-Label, Dose Escalation and Expansion Study of Demcizumab Plus Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Research type
Research Study
Full title
A Phase 1b, Open-Label, Dose Escalation and Expansion Study of Demcizumab Plus Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
IRAS ID
191752
Contact name
Johann DeBono
Contact email
Sponsor organisation
OncoMed Pharmaceuticals
Eudract number
2015-004180-36
Clinicaltrials.gov Identifier
123143, IND number
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
Current cancer therapies often produce an initial reduction in tumour size but may not have long-term benefits. A specific type of cancer cell known as a cancer stem cell (CSC) is thought to be accountable for this. CSCs represent a small part of the tumour but are believed to be responsible for much of the growth and spread of the cancer. CSCs may also be more resistant to traditional types of cancer therapy.
Antibodies are part of the natural immune system that helps to fight infections. Demcizumab is an antibody made in the laboratory, it has been developed to target CSCs and may block their growth and also prevent the growth of new blood vessels that tumours need to grow and spread.
In this study, demcizumab will be given in combination with another study medication called pembrolizumab which has been approved in the UK for the treatment of melanoma (a type of skin cancer). The objective of this study is to assess the safety and tolerability of the combination of demcizumab and pembrolizumab in participants with solid tumours that have either grown outside the organ they started in or spread to other parts of the body.
Approximately 64 participants will be enrolled at 10 sites globally. In the UK, up to 10 participants will be enrolled at 1 site (Royal Marsden Hospital, London) into the Castrate Resistant Prostate Cancer study cohort.
2.5 or 5 mg/kg of demcizumab will be administered once every 3 weeks for 4 doses. A second course of demcizumab may be administered once every 3 weeks for 4 doses (starting on Day 169) if deemed safe. Pembrolizumab will be given at 2mg/kg, every 3 weeks during the course of the study. Participants will continue on the study until their disease worsens or unacceptable side effects occur.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/0397
Date of REC Opinion
22 Apr 2016
REC opinion
Further Information Favourable Opinion