Description:
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
Title
- Brief Title: Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
- 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 IDs
- ORG STUDY ID:
CA209-9TM
- SECONDARY ID:
2017-002676-87
- NCT ID:
NCT03349710
Conditions
- Squamous Cell Carcinoma of the Head and Neck
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | BMS-936558, Opdivo | Arm A |
Cetuximab | Erbitux | Arm A |
Placebo | | Arm B |
Cisplatin | | Arm C |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | Cohort 1 | |
Arm B | Experimental | Cohort 1 | |
Arm C | Experimental | Cohort 2 | |
Arm D | Experimental | Cohort 2 | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Event Free Survival (EFS) |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | EFS is defined as the time from randomization to radiographic progression, as determined by a Blinded Independent Central Review (BICR) |
Secondary Outcome Measures
Measure: | Duration of loco-regional control (DLRC) |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | DLRC is defined as the time from randomization to loco-regional relapse |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | OS is defined as time from randomization until death from any cause |
Measure: | European Organisation for the Research and Treatment of Cancer (EORTC) |
Time Frame: | Up to one year |
Safety Issue: | |
Description: | Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score |
Measure: | Quality of Life Questionnaire-Core 30 (QLQ-C30) |
Time Frame: | Up to one year |
Safety Issue: | |
Description: | Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score |
Measure: | European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Head and Neck (QLQQH&N35) |
Time Frame: | Up to one year |
Safety Issue: | |
Description: | Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
April 27, 2018