TRYbeCA-1 – TRial of erYaspase in pancreatic CAncer
Research type
Research Study
Full title
A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma.
IRAS ID
245798
Contact name
Harpreet WASAN
Contact email
Sponsor organisation
ERYTECH Pharma
Eudract number
2018-000572-15
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Trybeca1 is an open-label, global, randomized phase 3 study of eryaspase in combination with chemotherapy (gemcitabine/abraxane combination or irinotecan-based chemotherapy (FOLFIRI [FOLinic acid-Fluorouracil-IRInotecan regimen] or Onivyde®/5-fluorouracil/leucovorin) versus chemotherapy alone in patients who have failed only one prior line of systemic anti-cancer therapy for metastatic pancreatic cancer.
Patients will receive treatment until disease progression, unacceptable toxicity, or withdrawal of consent, and will be followed up for survival every 8-weeks.
Eryaspase is made up of red blood cells and (L asparaginase) kept inside the RBCs. This enzyme (L asparaginase) has been used to treat other types of cancer. When kept inside the RBCs, it is protected from the immune system and it removes an important nutrient (amino acid) from the bloodstream necessary for cancer cells growth, this may lead to its “starvation” and death and improve patient survival. The choice of the chemotherapy regimen for a particular patient will be determined by the investigator based on prior treatment received in the first-line setting (those previously treated with gemcitabine-based regimens will receive an irinotecan-based regimen and vice versa).Eligible patients are at least 18 years old with histologically confirmed Stage III or IV pancreatic ductal adenocarcinoma with radiological evidence of disease progression following failure of first line treatment, have measurable lesion (RECIST 1.1), and must have adequate performance status (ECOG PS 0 or 1). Study will enroll 482 patients up to a maximum of 602 patients.
Determination of efficacy, will be based on comparison of Overall Survival, PFS, ORR, DCR, and DoR between treatment arms; evaluation of safety and tolerability; assessment of effect on quality of life using (EORTC QLQ-C30); other assessments are PK; immunogenicity; biomarkers and (pharmacogenetics. Trybeca1 will be monitored by an Independent Data Monitoring Committee (IDMC) and a Steering Committee (SC) to oversee study activities.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1215
Date of REC Opinion
22 Aug 2018
REC opinion
Further Information Favourable Opinion