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Nivolumab in Recurrent and/or Metastatic SCCHN

NCT03226756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2023-01-18

No results posted yet for this study

Summary

Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common clinical situation and although this group of patients has very heterogeneous disease characteristics, they share a dismal prognosis with a median survival time around 6-11 months and a relatively poor quality of life.

Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC) and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361 patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this condition and whose disease had progressed within 6 months after platinum-based chemotherapy. In this study, treatment with nivolumab resulted in significantly longer survival than treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months (p=0.01).

The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck patients.

Conditions

  • Recurrent and/or Metastatic Platinum-refractory SCCHN

Interventions

DRUG

Nivolumab Injection

Nivolumab 3 mg/kg, every 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Caroline Even, MD · Gustave Roussy Cancer Campus - Villejuif

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2017-12-31
Completion
2022-05-31

Countries

  • France

Study Locations

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Entities

Companies

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 NCT03226756 on ClinicalTrials.gov