A Phase I/II Study Evaluating the Safety and Clinical Activity of Anti-PDL1 (Durvalumab [MEDI4736]) + Anti CTLA-4 (Tremelimumab) Antibodies Administrated in Combination With Stereotactic Body Radiotherapy (SBRT) in Patients With Metastatic Squamous Cell Carcinoma of Head and Neck, Lung, Oesophageus, Cervix, Vagina,Vulva or Anus

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country54 target enrollmentJune 20, 2017

ConditionsHead and Neck Squamous Cell Carcinoma Lung Cancer Oesophageal Cancer

InterventionsDurvalumab Tremelimumab SBRT

DrugsDurvalumab Tremelimumab

Overview

Phase: Phase 1
Intervention: Durvalumab
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Enrollment: 54
Locations: 1
Primary Endpoint: Dose Limiting Toxicity (DLT)
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.

Registry

clinicaltrials.gov

Start Date

June 20, 2017

End Date

February 24, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or Female patients ≥18 years of age or older.
•Histologically or cytologically proven metastatic squamous cell carcinoma (from head and neck, oesophagus, lung, cervix, vagina, vulva or anus) with the following features:
•Previously treated with at least one prior regimen (chemotherapy, signal transduction inhibitors or radiotherapy)
•To be treated with radiotherapy at primary tumor site or metastatic site or menacing metastatic site.
•The sites of metastases allowed are: soft tissue, peripheral lung, and liver.
•Patients with brain and bone metastasis to be treated with radiotherapy are not allowed. Patients with asymptomatic brain metastasis can be included.
•The total tumor volume to be irradiated must not exceed 400 cc.
•At least one tumor lesion must be accessible to radiation therapy and at least another tumor site can be spared from radiation therapy (unirradiated site).
•At least one unirradiated and one irradiated tumor site must be accessible to tumor biopsy.
•Known availability of an archived block

Exclusion Criteria

•Any situation where the irradiation of the target site would imply reirradiation of a formerly irradiated tumor site.
•Patients with any concurrent severe and/or uncontrolled disease which could compromise participation in the study including:
•Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction
•Active or prior documented autoimmune disease within the past 2 years. Of note, patient with vitiligo, Grave's disease or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Patients with type 1 diabetes or hypothyroidism stable under treatment or not requiring systemic treatment are eligible.
•Active or prior documented inflammatory bowel disease (eg Crohn's disease, ulcerative colitis)
•History of primary immunodeficiency
•Severe chronic or acute infection such as chronic HBV, HCV and HIV1, 2 infection, active tuberculosis infection
•Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active non-infectious pneumonitis
•History of allogenic organ transplant
•Uncontrolled diabetes,