Trial of Nivolumab vs Therapy of Investigator’s Choice in Recurrent or Metastatic Head and Neck Carcinoma

An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) - CheckMate 141: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 141

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003622-86-NL

Enrollment

225

Registered

2014-06-26

Start date

2014-07-29

Completion date

Unknown

Last updated

2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of the head and neck MedDRA version: 18.0 Level: PT Classification code 10066471 Term: Squamous cell carcinoma of pharynx System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10041857 Term: Squamous cell carcinoma of the oral cavity System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classificatio

Interventions

Product Name: Nivolumab Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-936558-01 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men and women = 18 years of age with an ECOG performance status = 1. - Histologically confirmed recurrent or metastatic HNSCC (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). - Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting. - Measurable disease by CT or MRI per RECIST 1.1 criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: - Active brain metastases or leptomeningeal metastases are not allowed. - Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or nonsquamous histologies - Subjects with active, known or suspected autoimmune disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to find out whether nivolumab will significantly improve progression-free survival and/or overall survival as compared to therapy of investigator’s choice in patients with recurrent or metastatic head and neck carcinoma.;Secondary Objective: Objective Response Rate;Primary end point(s): Co-primary endpoints: Progression-Free Survival (PFS) and Overall Survival (OS);Timepoint(s) of evaluation of this end point: For PFS: Starting at week 9 and then every 6 weeks after randomization, until disease progression For OS: Every 3 months during the survival follow-up phase	—

Measure

Time frame

Main Objective: The purpose of this study is to find out whether nivolumab will significantly improve progression-free survival and/or overall survival as compared to therapy of investigator’s choice in patients with recurrent or metastatic head and neck carcinoma.;Secondary Objective: Objective Response Rate;Primary end point(s): Co-primary endpoints: Progression-Free Survival (PFS) and Overall Survival (OS);Timepoint(s) of evaluation of this end point: For PFS: Starting at week 9 and then every 6 weeks after randomization, until disease progression For OS: Every 3 months during the survival follow-up phase

—

Secondary

Measure	Time frame
Secondary end point(s): Objective Response Rate;Timepoint(s) of evaluation of this end point: Starting at week 9 and then every 6 weeks after randomization, until disease progression or study drug is discontinued (whichever occurs later).	—

Countries

Argentina, Canada, France, Germany, Hong Kong, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactEU Study Start-Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026