CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Nivolumab 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03370276
NCT03370276Phase 2Completed
CompareCT.gov

A Phase I/II Study of Concurrent Cetuximab and Nivolumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 12, 2017·Updated Apr 2, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab and Cetuximab for Squamous Cell Carcinoma of the Oropharynx and 7 related conditions. Completed, enrolled 95 participants across 3 sites.

Detailed Summary

The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Hypopharynx, Squamous Cell Carcinoma of the Paranasal Sinus, Head and Neck Squamous Cell Carcinoma, Squamous Cell Cancer, Head and Neck Carcinoma
CountriesUnited States
CollaboratorsJames and Esther King Biomedical Research Program, Eli Lilly and Company, Bristol-Myers Squibb

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 12, 2017
Enrollment StartDec 20, 2017
Primary CompletionSep 4, 2021
Study CompletionDec 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.6 years ago

Interventions

Nivolumabdrug

Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms.

Cetuximabdrug

Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.