Carcinoma, Squamous CellTAPESTRYNCT04481256
TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY
A study testing External beam radiotherapy, Bintrafusp alfa and Paclitaxel in people with Carcinoma, Squamous Cell and Oesophageal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The primary objective 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell, Oesophageal Cancer
- What is being tested?
- External beam radiotherapy, Bintrafusp alfa and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2020to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven squamous cell carcinoma of the esophagus or gastro esophageal junction.
- Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen. Patients with M1 disease solely on the basis of supraclavicular metastasis are eligible. Patients with resectable tumors refusing radical surgery are eligible.
- Locoregional recurrences without distant metastasis after surgery alone or endoscopical resection
- Locoregional recurrences without distant metastasis after neoadjuvant chemoradiation + resection or definitive chemoradiation outside the previously irradiated area, provided that full dose of radiation can safely be delivered.
- Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible if all other criteria are fulfilled.
- If the tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction.
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- Age ≥ 18.
- ECOG performance status 0-2 (cf. Appendix A).
- Adequate hematological, renal and hepatic functions defined as:
- Neutrophils ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 5.6 mmol
- Total bilirubin ≤ 1.5 x upper normal limit
- ASAT and ALAT ≤ 1.5 x upper normal limit, Alkaline Phosphatase ≤ 2.5 x upper normal limit.
- PT (INR) ≤ 1.5 x upper normal limit and aPTT ≤ 1.5 x upper normal limit.
- Creatinine clearance (Cockroft) > 60 ml/min
- Written, voluntary informed consent
- Patients must be accessible to management and follow-up in the treatment center
Who cannot join
- Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
- Patient with tracheo-esophageal fistula or extension into the mucosal layer of the trachea, highly at risk to develop fistula. Thus, tumor extension to the trachea is allowed, but not through the trachea.
- Patients with pathological lymph nodes at both supraclavicular and truncus coeliacus level.
- Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
- Patient (male or female) in the reproductive age is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
- Previous chemotherapy, radiation and/or treatment with checkpoint inhibitors for the currently present esophageal tumor.
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- Previous chemotherapy and/or treatment with targeted agents and/or checkpoint inhibitors for other forms of cancer within the last six months.
- Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor.
- Persisting grade >1 NCI CTCAE 5.0 toxicity (except alopecia and vitiligo) related to prior therapy; however, grade ≤2 sensory neuropathy is acceptable.
- Presence of an esophageal stent.
- History of bleeding diathesis or major bleeding event (grade ≥ 2) in the month prior to first dose of trial treatment.
- Current use of direct oral anticoagulants or coumarins.
- Clinically significant cardiovascular disease precluding safe treatment with chemoradiation.
- Evidence of pulmonary fibrosis and/or clinically significant impairment of lung function precluding safe treatment with chemoradiation. In case of doubt about pulmonary function, a lung function test should be performed and, in case of abnormalities, discussed with the principle investigator.
- Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide or cyclosporine.
- Mental status that would prohibit the understanding and giving of informed consent.
- Inadequate caloric- and/or fluid intake despite consultation of a dietician and/or tube feeding.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine for patients with a history of autoimmune-related hypothyroidism, insulin for patients with type 1 diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo with dermatological manifestations only are eligible to enter the study.
- A diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Diagnosis of HIV unless stable on antiretroviral therapy for at least 4 weeks, no evidence of multi-drug resistance, viral load of < 400 copies/ml and CD4+ T-cells ≥ 350 cells/µl.
- Active HBV/HCV. Participants on a stable dose of antiviral therapy with HBV/HCV viral load below the limit of quantification are eligible.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- An active infection requiring systemic therapy, which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
- Administration of a live vaccine within 30 days prior to the first dose of trial treatment. Seasonal flu vaccines that do not contain a live virus are permitted.
- Patients with prior allogeneic stem cell or solid organ transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center, Medical Oncology
Amsterdam, 1100 DD
H WM van Laarhoven, MD, PhD, PhD, 31 20 5665955, h.vanlaarhoven@amc.uva.nl
Lyda ter Hofstede, 31 20 5668229, trialmedonc@amc.uva.nl
About this study
The primary objective 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.
Read the detailed description
Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.
- Conditions
- Carcinoma, Squamous Cell, Oesophageal Cancer
- Being tested
- External beam radiotherapy, Bintrafusp alfa, Paclitaxel, Carboplatin
- Keywords
- Definitive chemoradiation, TGF-beta inhibition, PDL-1 ihibition, feasability
- Medical subject headings
- Carcinoma, Squamous Cell, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiotherapyRadiation
External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy
Bintrafusp alfaDrug
Also called M7824
Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.
PaclitaxelDrug
Also called Taxol
Paclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
CarboplatinDrug
Carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
| Study group | Role | What they receive |
|---|---|---|
| 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy | Experimental | Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.
External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy Receives: Radiation: External beam radiotherapy; Drug: Bintrafusp alfa; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility difined as the percentage of patients completing at least two cycles of bintrafusp alfa
The primary outcome of this study is the percentage of patients that completes at least two cycles of bintrafusp alfa together with their chemoradiotherapy regimen.
Measured: 36 months
Secondary outcomes (8)
Incidence and severity of toxicity
Incidence and severity of toxicity defined according to CTCAE v5 and and Radiation Oncology Group (RTOG) criteria.
Measured: 36 months
Percentage completion
Percentage completion of chemotherapy and radiation treatment
Measured: 36 months
Percentage withdrawal rate
Percentage withdrawal rate from chemoradiation due to bintrafusp alfa related complications
Measured: 36 months
locoregional progression
Infield locoregional progression free survival
Measured: 36 months
progression
Any progression free survival
Measured: 36 months
Survival
Overall survival
Measured: 36 months
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ C30))
Overall Quality of life ranging from 0-100 with 100 being best Quality of Life with special focus on dysphagia
Measured: 36 months
adverse events
To determine the number and grade of adverse events of bintrafusp alfa combined with chemoradiotherapy according to NCI common toxicity criteria (CTC) version 5
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start11 Nov 2020
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Catharina Ziekenhuis Eindhoven, Institute Verbeeten, Elisabeth-TweeSteden Ziekenhuis, Leiden University Medical Center, Radiotherapeutic Institute Friesland, Frisius Medisch Centrum, Radiotherapy Group Deventer, Deventer Ziekenhuis, Rijnstate Hospital, Erasmus Medical Center, The Netherlands Cancer Institute, Isala, University Medical Center Groningen, Ziekenhuisgroep Twente
- Responsible party
- Principal investigator, Hanneke W. M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Hanneke WM van Laarhoven, MD,PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481256
- Sponsor's protocol ID
- 73750
- Acronym
- TAPESTRY
- Status last verified
- Jul 2024
- First submitted
- 26 May 2020
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY
- ClinicalTrials.gov ID
- NCT04481256
- Acronym / sponsor ID
- TAPESTRY / 73750
- Conditions
- Carcinoma, Squamous Cell, Oesophageal Cancer
- Keywords
- Definitive chemoradiation, TGF-beta inhibition, PDL-1 ihibition, feasability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- UMC Utrecht, Catharina Ziekenhuis Eindhoven, Institute Verbeeten, Elisabeth-TweeSteden Ziekenhuis, Leiden University Medical Center, Radiotherapeutic Institute Friesland, Frisius Medisch Centrum, Radiotherapy Group Deventer, Deventer Ziekenhuis, Rijnstate Hospital, Erasmus Medical Center, The Netherlands Cancer Institute, Isala, University Medical Center Groningen, Ziekenhuisgroep Twente
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective 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.
Detailed description
Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy | Experimental | Radiation: External beam radiotherapy, Drug: Bintrafusp alfa, Drug: Paclitaxel, Drug: CarboplatinNon-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically proven squamous cell carcinoma of the esophagus or gastro esophageal junction.
- Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen. Patients with M1 disease solely on the basis of supraclavicular metastasis are eligible. Patients with resectable tumors refusing radical surgery are eligible.
- Locoregional recurrences without distant metastasis after surgery alone or endoscopical resection
- Locoregional recurrences without distant metastasis after neoadjuvant chemoradiation + resection or definitive chemoradiation outside the previously irradiated area, provided that full dose of radiation can safely be delivered.
- Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible if all other criteria are fulfilled.
Key exclusion criteria (25 listed)
- Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
- Patient with tracheo-esophageal fistula or extension into the mucosal layer of the trachea, highly at risk to develop fistula. Thus, tumor extension to the trachea is allowed, but not through the trachea.
- Patients with pathological lymph nodes at both supraclavicular and truncus coeliacus level.
- Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
- Patient (male or female) in the reproductive age is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiotherapyExternal beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy | Radiation | 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy |
| Bintrafusp alfaAlso: M7824Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. | Drug | 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy |
| PaclitaxelAlso: TaxolPaclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. | Drug | 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy |
| CarboplatinCarboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. | Drug | 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy |
Primary outcome
Feasibility difined as the percentage of patients completing at least two cycles of bintrafusp alfa
Time frame: 36 months
The primary outcome of this study is the percentage of patients that completes at least two cycles of bintrafusp alfa together with their chemoradiotherapy regimen.
8 secondary outcomes
Incidence and severity of toxicity
Time frame: 36 months
Percentage completion
Time frame: 36 months
Percentage withdrawal rate
Time frame: 36 months
locoregional progression
Time frame: 36 months
progression
Time frame: 36 months
Survival
Time frame: 36 months
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ C30))
Time frame: 36 months
adverse events
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanneke WM van Laarhoven, MD,PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External beam radiotherapy, Bintrafusp alfa and Paclitaxel in people with Carcinoma, Squamous Cell and Oesophageal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linde M Veen, MD (+31 20 4443312, l.veen1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility difined as the percentage of patients completing at least two cycles of bintrafusp alfa (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.