Study Comparing AlloVax™ to Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck

NCT02624999 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-01-22

No results posted yet for this study

Summary

Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .

Conditions

  • Squamous Cell Carcinoma Head and Neck

Interventions

BIOLOGICAL

AlloVax™

AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens

DRUG

Cisplatin

Subjects in the chemotherapy arm will receive up to 6 cycles of cisplatin on day 0 of the 3-week cycle at dose of 80-100 mg/m2 IV and 1000 mg/m2 IV 5FU on days 1-4 of the cycle

Sponsors & Collaborators

  • Mirror Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Har-Noy, Dr. · CEO & CTO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2016-12-31
Completion
2017-05-31

Countries

  • Thailand

Study Locations

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Entities

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 NCT02624999 on ClinicalTrials.gov