Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

NCT04054518 | Unknown Phase 2

• 1 other identifier: 1473/19
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Single arm phase II trial designed to assess the efficacy of durvalumab treatment in terms of 6-month progression-free survival. We will include 22 patients who will receive 1500 mg durvalumab (MEDI4736) via IV infusion Q4W \<\<for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48\>\> or \<\<until confirmed disease progression\>\> unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30 kg or below for 1 week or longer ( ≥ 7 days) durvalumab will be permanently discontinued.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Six-month progression-free survival

  The primary endpoint is the percentage of subjects who remain progression free at 6 months using investigator assessments according to RECIST 1.1

  6 months

Secondary Outcomes (4)

• Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

  From time of informed consent through treatment period (12 months) or up to 12 months post last dose of study treatment.

• Overall survival

  From time of informed consent until the date of death from any cause, assessed up to 60 months

• Incidence of locoregional progression

  From time of informed consent through treatment period (12 months) or up to 12 months post last dose of study treatment.

• Incidence of distant progression

  From time of informed consent through treatment period (12 months) or up to 12 months post last dose of study treatment.

Other Outcomes (1)

• Six-month progression-free survival according to immune biomarkers

  6 months

Study Arms (1)

Durvalumab

EXPERIMENTAL

1500 mg durvalumab (MEDI4736) via IV infusion Q4W \<\<for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48\>\> or \<\<until confirmed disease progression\>\> unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Drug: Durvalumab

Interventions

Durvalumab DRUG

Durvalumab (MEDI4736) will be supplied as a 500-mg vial solution for infusion after dilution.

Also known as: MEDI4736

Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body weight \>30kg and body mass index ≥ 16 kg / m2;
• Patients aphagic or able to ingest only liquids should also receive enteral nutritional sup-port before being included in the study;
• Patients must have histologically confirmed esophageal or esophagogastric junction (Siewert I or II) squamous cell carcinoma, irrespective of PD-1/PD-L1 or other biomarkers expression;
• Patients must have had a persistent disease 6-8 weeks after completing chemoradiotherapy with at least 50 Gy and platinum-based chemo and without complete response or progressive disease, based on upper endoscopy and/or CT scans;
• Patients must have realized CT scans within 6-8 weeks after completion of chemoradiotherapy, revealing persistent disease;
• Patients must be included \<12 weeks after completing chemoradiotherapy;
• Patients must be unsuitable to salvage esophagectomy, according multidisciplinary local board;
• All the tumor volume should have been treated with CRT (included in the radiation field);
• Eastern Cooperative Oncology Group (ECOG)\>\>\<\<World Health Organisation (WHO) performance status of 0 or 1;
• Male or female aged 18 years or older at time of study entry;
• Life expectancy of \> 12 weeks;
• Adequate normal organ and marrow function as defined below:
• Haemoglobin ≥9.0 g/dL
• Absolute neutrophil count (ANC) 1.5 x (\> 1500 per mm3)
• Platelet count ≥100 x 109/L

You may not qualify if:

• Patients with metastases including lymph node not included in the radiation field;
• Patients currently receiving or have had prior use of immunosuppressive medication within 28 days before the first dose of study drug (10 milligrams/day of prednisone or an equivalent corticosteroid is allowed);
• Received any immunotherapy for esophageal cancer;
• Patients with active hepatitis B, hepatitis C or human immunodeficiency virus (HIV1/2 antibodies);
• Has known active or prior autoimmune disease, except for:
• skin diseases (vitiligo, psoriasis, alopecia)
• diabetes mellitus type 1, with hormone replacement
• hypothyroidism, with hormone replacement
• Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
• Grade 3 or higher pulmonary toxicity of dyspnea, hypoxia, or pneumonitis experienced during chemoradiation;
• Presence of fistula between esophagus and trachea unless treated with endoscopic prosthesis.

Sponsors & Collaborators

• Tiago Biachi: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, 01346000, Brazil

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Tiago B de Castria, MD PhD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiago B de Castria, MD PhD

CONTACT

+551138934531; tiagobiachi@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)