Ramucirumab in Synovial Sarcoma (JV02 study)
Research type
Research Study
Full title
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Synovial Sarcoma
IRAS ID
261602
Contact name
Aasman Askar
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-004243-23
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This Study (JV02) is part of a collection of paediatric studies being done by Eli Lilly under the Paediatric Platform trial known as CAMPFIRE which will investigate new treatments for paediatric and young adult patients with cancer. The study aims to evaluate the effectiveness and safety of Ramucirumab in combination with gemcitabine and docetaxel in paediatric and young adults with relapsed, recurrent or persistant Synovial Sarcoma (SS).
SS is a rare form of Soft Tissue Sarcoma (STS) which occurs primarily in the arms or legs, and is found in both children and adults. As surgery is currently the only definitive path to cure, the current standard approach for treatment of local disease is surgery with or without radiation therapy and/or chemotherapy. While SS tumours are thought to be initially responsive to chemotherapy, there is no defined standard treatment for SS as treatment strategies have been difficult to identify due to the rarity of this disease. Despite initial treatment, approximately 40% of patients with SS develop recurrent or resistant disease.
Ramucirumab is an anti-angiogenic agent, which means it interferes with a cancer's ability to make and maintain new blood vessels, which are necessary for continued tumor 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 gemcitabine and docetaxel has been investigated in paediatric and young adult patients with STS. Studies evaluating the combination with another anti-angiogenic agent hav shown positive results in STS patients. These results and the need to identify better treatment options for patients with relapsed, refractory or persistent SS is justification for this study.
JV02 will run for 24 months and includes 4 periods: screening, treatment (until disease progression occurs or treatment is no longer beneficial), short term follow up and long term follow up.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0010
Date of REC Opinion
27 Feb 2020
REC opinion
Further Information Favourable Opinion