TGF-β And PDL-1 inhibition with Bintrafusp alfa in Esophageal Squamous Cell carcinoma combined with chemoradiation TheRapY (TAPESTRY)

Conditions

Esophageal squamous cell carcinoma

Brief summary

The primary endpoint is feasibility defined as percentage of patients that complets at least two of the three planned cylces of bintrafusp alfa

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGBintrafusp alfa (anti-PD-L1/TGFβ Trap)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is feasibility defined as percentage of patients that complets at least two of the three planned cylces of bintrafusp alfa	—

Secondary

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

Measure

Time frame

Incidence and severity of toxicity defined according to CTCAE v5 and Radiation Oncology Group (RTOG) criteria, Safety of bintrafusp alfa in combination with definitive chemoradiotherapy, Percentage completion of chemotherapy and radiation treatment, Infield locoregional progression free survival, Any progression free survival, Overall survival, Quality of life, with a special focus on dysphagia, Potential biomarker development based on assessment of tumour and duodenal biopsies, faeces and blood samples, Occurrence of TEAEs and treatment related AEs, including abnormalities (grade ≥3) in laboratory tests, 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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Countries

Netherlands

Outcome results

None listed