Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349710
• Other study ID #: CA209-9TM
• Secondary ID: 2017-002676-87
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2017
• Est. completion date: October 14, 2019

Study information

• Verified date: August 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx
• Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
• No previous radiotherapy or systemic treatment for SCCHN

Exclusion Criteria:

• Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary
• Clinical or radiological evidence of metastatic disease
• Prior radiotherapy that overlaps with radiation fields Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Biological:
• Nivolumab
Specified dose on specified day

Drug:
• Cetuximab
Specified dose on specified day
• Cisplatin
Specified dose on specified day

Radiation:
• Radiotherapy
Specified dose on specified day

Locations

Country	Name	City	State
France	Local Institution	Grenoble
France	Local Institution	Marseille
France	Local Institution	Nice
Italy	Local Institution	Lucca
Italy	Local Institution	Ravenna
Japan	Local Institution	Akashi-shi	Hyogo
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Isehara	Kanagawa
Japan	Local Institution	Kashiwa-shi	Chiba
Japan	Local Institution	Kobe-shi	Hyogo
Japan	Local Institution	Matsuyama-shi	Ehime
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Natori-shi	Miyagi
Japan	Local Institution	Osaka
Japan	Local Institution	Osaka-sayama-shi	Osaka
Japan	Local Institution	Tsukuba-shi	Ibaraki
Korea, Republic of	Local Institution	Cheongju-si
Korea, Republic of	Local Institution	Jeollanam-do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Poland	Local Institution	Gdynia
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Yekaterinburg
Spain	Local Institution	A Coruna
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Majadahonda
Spain	Local Institution	Valencia
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Turkey	Local Institution	Izmir
United States	Pinnacle Research Group, Llc	Anniston	Alabama
United States	Winship Cancer Insitute, Emory Crawford Long Hospital	Atlanta	Georgia
United States	HHP Hematology & Oncology Bremerton	Bremerton	Washington
United States	St. Joseph Regional Cancer Center	Bryan	Texas
United States	Inova Health System	Falls Church	Virginia
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Cancer Treatment Centers of Phoneix	Goodyear	Arizona
United States	The University of Texas MD Anderson Cancer Center-merge	Houston	Texas
United States	Monter Cancer Center - Center for Advanced Medicine Location	Lake Success	New York
United States	UCLA Health	Los Angeles	California
United States	CTCA Southeastern Region	Newnan	Georgia
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Orlando Health, Inc	Orlando	Florida
United States	Eastern Regional Medical Center	Philadelphia	Pennsylvania
United States	Upmc- Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Cancer Center of Central Connecticut	Plainville	Connecticut
United States	Cancer Care - Torrance Memorial Physician Network	Redondo Beach	California
United States	Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital	Thomasville	Georgia
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Midwestern Regional medical Center	Zion	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  France,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Adverse Event (AE)	Number of Participants with an Adverse Event	30 Days
Primary	Number of Participants With an Serious Adverse Event (SAE)	Number of Participants with an Serious Adverse Event (SAE)	30 days
Primary	Number of Participants With an Adverse Event Leading to Discontinuation	Number of Participants with an Adverse Event Leading to Discontinuation	30 Days
Primary	Number of Participants With an Adverse Event Leading to Dose Modification	Number of Participants with an Adverse Event Leading to dose modification	30 Days
Primary	Number of Participants With Select Adverse Events	Number of Participants with select adverse events.; Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.	30 Days
Primary	Number of Participants With an Immune-mediated Adverse Event (IMAE)	Number of Participants with an immune-mediated adverse event (IMAE)	100 days
Primary	Time to Onset and Time to Resolution of Immune-related Adverse Events	Time to onset and time to resolution of immune-related adverse events	100 days
Primary	Number of Participants Who Experienced Death	Number of Participants who experienced death	100 days
Primary	Number of Participants With an Abnormality in Specific Thyroid Tests	Number of participants with an abnormality in specific thyroid tests	30 Days
Primary	Number of Participants With an Abnormality in Specific Liver Tests	Number of participants with an abnormality in specific liver tests	30 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls