A phase III randomized trial of post-operative adjuvant nivolumab and concomitant chemo-radiotherapy in high-risk patients with resected squamous cell carcinoma of head and neck (SCCHN)

Conditions

resected squamous cell carcinoma of head and neck

Brief summary

Disease free survival (DFS by investigator imaging assessments) defined as the time between the date of randomization and the date of first loco-regional or distant recurrence or death (of any cause) whichever occurs first,..

Detailed description

Overall survival, DFS by blinded independent central imaging review, DFS and OS by PDL-1 status, Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure and cumulative incidence of death without previous progression, Incidence of second primary malignancy (SCC to a distance >= 3 cm from the tumor bed and that will clearly not be attributable to a relapse or a second cancer arising outside the upper aero digestive track)., Safety: Adverse events and laboratory abnormalities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). Incidence of delayed toxicity of radiotherapy (e.g. dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes)., Correlation between the immune landscape and patients’ outcome

Related papers

No related papers found yet.

Interventions

DRUGCISPLATINE ACCORD 1 mg/ml

DRUGsolution à diluer pour perfusion

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease free survival (DFS by investigator imaging assessments) defined as the time between the date of randomization and the date of first loco-regional or distant recurrence or death (of any cause) whichever occurs first,..	—

Secondary

Measure	Time frame
Overall survival, DFS by blinded independent central imaging review, DFS and OS by PDL-1 status, Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure and cumulative incidence of death without previous progression, Incidence of second primary malignancy (SCC to a distance >= 3 cm from the tumor bed and that will clearly not be attributable to a relapse or a second cancer arising outside the upper aero digestive track)., Safety: Adverse events and laboratory abnormalities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). Incidence of delayed toxicity of radiotherapy (e.g. dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes)., Correlation between the immune landscape and patients’ outcome	—

Measure

Time frame

Overall survival, DFS by blinded independent central imaging review, DFS and OS by PDL-1 status, Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure and cumulative incidence of death without previous progression, Incidence of second primary malignancy (SCC to a distance >= 3 cm from the tumor bed and that will clearly not be attributable to a relapse or a second cancer arising outside the upper aero digestive track)., Safety: Adverse events and laboratory abnormalities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). Incidence of delayed toxicity of radiotherapy (e.g. dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes)., Correlation between the immune landscape and patients’ outcome

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Countries

Belgium, France, Greece, Poland, Spain

Outcome results

None listed