Cancer types
  • Digestive tract
Title of study
TGF-β And PDL-1 inhibition with Bintrafusp alfa in Esophageal Squamous Cell carcinoma combined with chemoradiation TheRapY
Version Number
Approval Date 
1.4, 8 Octobre 2020
Short Title
TAPESTRY
Study site
Principle Investigator
Prof. Dr. H.W.M. van Laarhoven
Investigator Maastro
Dr M. Berbée
Sponsor
Amsterdam University Medical Centers, location AMC
Trial registry
Objectives 

The primary objective of the study of this study is to assess the feasibility of treatment with bintrafusp alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.

Secondary objectives are:
• Incidence and severity of toxicity defined according to CTCAE v5 and and Radiation Oncology Group (RTOG) criteria.
• Percentage completion of chemotherapy and radiation treatment
• Percentage withdrawal rate from chemoradiation due to bintrafusp alfa related complications
• Safety of bintrafusp alfa in combination with chemoradiation
• Occurrence of TEAEs and treatment related AEs, including obnormalities (grade ≥3) in laboratory tests
• Infield locoregional progression free survival
• Any progression free survival
• Overall survival
• Quality of life, with a special focus on dysphagia Explorative objectives are:
– To perform exploratory biomarker analyses for treatment response.
– To assess patient reported outcomes in addition to quality of life, including but not limited to anxiety and depression, worry of cancer progression and work productivity.

Primary Endpoint 

The primary endpoint is feasibility defined as percentage completion of treatment with bintrafusp alfa.

Secondary Endpoints 

• Incidence and severity of toxicity defined according to CTCAE v5 and Radiation Oncology Group (RTOG) criteria.
• Percentage completion of chemotherapy and radiation treatment.
• Safety of bintrafusp alfa in combination with chemoradiation
• Infield locoregional progression free survival
• Occurrence of TEAEs and treatment related AEs, including abnormalities (grade ≥3) in laboratory tests
• Any progression free survival.
• Overall survival.
• Quality of life, with a special focus on dysphagia Exploratory endpoints:
– Potential biomarker development based on assessment of tumour and duodenal biopsies, blood- and faecal samples.
– Patient reported outcomes other than quality of life, including but not limited to anxiety and depression, worry of cancer progression and work productivity.

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