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Targeting the Tumor Microenvironment in R/M SCCHN

NCT03844763 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-03-03

No results posted yet for this study

Summary

Phase I - II trial of the combination of cyclophosphamide, RT, and Avelumab in relapsed/metastatic HNSCC (R/M-HNC). Patients pretreated with at least one line therapy containing platinum, fluorouracil, and Cetuximab. Treatment consists of metronomic cyclophosphamide 50 mg daily without drug free break, avelumab 10 mg/kg d1 and 15 q 29, and radiotherapy in one or three daily fractions up to 8 Gy maximum dose, starting at day 8. The aim of the study is to reverse tumor immune-escape by:

1. Provide a self-vaccination with radiotherapy
2. Inhibit the immunosuppressive CD4+ CD25+ FoxP3+ Treg cells with metronomic cyclophosphamide
3. Reactivate the effector T cell by the inhibition of PD-1 - PD-L1 axis with avelumab.

Due to the supposed biological effects of the present trial, an ancillary translational study is needed and will be extended to all the patients' population enrolled.

Conditions

Interventions

DRUG

Avelumab

Avelumab: 10 mg/kg every 2 weeks, untill PD or major toxicity

DRUG

CTX

CTX: 50 mg Daily untill PD or major toxicity

RADIATION

RT

RT: 8 Gy single shot day 8

Sponsors & Collaborators

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • MARCO C MERLANO, DR · AO S CROCE E CARLE DI CUNEO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844763 on ClinicalTrials.gov