Ramucirumab in Desmoplastic Small Round Cell Tumour (JV01 Study)
Research type
Research Study
Full title
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Paediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumour
IRAS ID
262268
Contact name
Aasman Askar
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-004242-42
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study (JV01) is part of a collection of Eli Lilly paediatric studies being done by Eli Lilly under the Paediatric Platform trial,CAMPFIRE which will investigate new treatments for paediatric and young adult patients with cancer. The JV01 study aims to evaluate the effectiveness and safety of ramucirumab in combination with cylophosphamide and vinorelbine in paediatric and young adult patients with relapsed, recurrent or persistent Desmoplastic Small Round Cell Tumour (DSRCT).
DSRCT is a rare cancer most often presenting with multiple tumours in multiple disease sites, and mainly found in adolescents and young adults. As surgery is currently the only definitive path to cure, the current standard approach for treatment of local disease is surgery in combination with radiation therapy and/or chemotherapy. While DSRCT tumours are thought to be at least initially responsive to chemotherapy, there is no defined standard treatment for DSRCT as treatment strategies have been difficult to identify due to the rarity of this disease. Despite initial treatment, long-term survival is uncommon.
Ramucirumab is an anti-angiogenic agent, which means that it interferes with cancer’s ability to make and maintain new blood vessels, which are necessary for continued tumour growth and survival. Ramucirumab has improved outcomes in adults with a number of different cancers and is now being tested in paediatric patients. The combination of cyclophosphamide and vinorelbine has been investigated in children and adolescent patients with DSCRT. Studies evaluating this combination with another anti-angiogenic agent has shown positive results in DSCRT patients. These results along with the need to identify better treatment options for patients with DSCRT is justification for this study.
JV01 is expected to run for approximately 24 months. There will be 4 study periods; screening, treatment (until disease progression occurs or treatment is no longer beneficial), short term and long term follow up phases.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0009
Date of REC Opinion
27 Feb 2020
REC opinion
Further Information Favourable Opinion