Nivolumab Plus Pemetrexed for Head and Neck Squamous Cell Carcinoma (NivoPlus)
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|ClinicalTrials.gov Identifier: NCT04107103|
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|SCCHN||Drug: Combination Product: Nivolumab with Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single-arm, interventional study combining nivolumab with pemetrexed|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Feasibility of the Combined Use of Nivolumab With Pemetrexed for the Treatment of Advanced Squamous Cell Carcinoma of the Head and Neck|
|Actual Study Start Date :||March 19, 2020|
|Estimated Primary Completion Date :||May 30, 2022|
|Estimated Study Completion Date :||May 30, 2022|
Experimental: Single Arm
A single-arm combining nivolumab with pemetrexed
Drug: Combination Product: Nivolumab with Pemetrexed
Nivolumab 3 mg/kg IV q.2 weekly in combination with pemetrexed 500mg/m2 q.6weekly. Treatment with nivolumab will continue every 14-days, and pemetrexed treatment will continue every 42-days. Treatment continues until disease progression or toxicity resulting in treatment discontinuation or until 2 years of treatment.
- Feasibility [ Time Frame: 1 year after enrollment of last participant ]The number of participants who complete at least 2 cycles of combination nivolumab with pemetrexed for the treatment of advanced head and neck cancers, over the total duration of study.
- Safety/tolerability (incidence of adverse events including immune related) [ Time Frame: Through study completion up to 2 years ]Treatment related and non-related adverse events per CTCAE v.4.0.3 of nivolumab with pemetrexed for the treatment of advanced head and neck cancers. Incidence of adverse events, the number of dose modifications and discontinuations due to adverse events including immune-related adverse events.
- Response Rate [ Time Frame: 1 year after enrollment of last participant. ]associated with combination nivolumab/pemetrexed therapy (defined as the proportion of participants achieving either a partial response or a complete response as best-overall response per RECIST criteria 1.1)
- Progression free survival [ Time Frame: 5 years from final study drug dose. ]associated with combination nivolumab/pemetrexed therapy (defined as the time between the date of treatment initiation and the date of disease progression or death (whatever the cause, whichever occurs first)
- Overall Survival [ Time Frame: 5 years from final study drug dose. ]associated with combination nivolumab/pemetrexed therapy. (Defined as the time between the date of treatment initiation and the date of death)
- Patient reported quality of life [ Time Frame: Through study completion, up to 2 years. ]associated with combination nivolumab/pemetrexed therapy (measured utilizing the Edmonton Symptom Assessment Score). This questionnaire includes six yes/no questions, 10 questions with a scale of 0 (no symptoms) to 10 (at the worst).
- Investigation of the role of CD71+ immature red blood cells in the response to treatment with immunotherapy [ Time Frame: 1 year after last study drug dose. ]In this study the frequency of the CD71+erythrocyte cells' (blood draws at pre-chemo, post-chemo and post immunotherapy) will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107103
|Contact: Hatim Karachiwala, MD FRCPCfirstname.lastname@example.org|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada|
|Principal Investigator:||Hatim Karachiwala, MD FRCPC||Alberta Health Services - Cross Cancer Institute|