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A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck

NCT03576417 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2025-05-07

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint )

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Cisplatin

Intravenous

DRUG

Nivolumab

Intravenous

RADIATION

RT

IMRT 66 Gy / 6.5 weeks

Sponsors & Collaborators

  • For Drug Consulting

    collaborator OTHER

  • Eurofins

    collaborator INDUSTRY

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2027-08-31
Completion
2027-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT03576417 on ClinicalTrials.gov