By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.
Have clinically confirmed head and neck cancer that is recurrent (comes back/returns to the body) or metastatic (spreads to other parts of the body).
Participants should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 3 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
Greater than or equal to 18 years old.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Has disease that is suitable for local therapy administered with curative intent.
Has progressive disease (PD) within three (3) months of completion of curatively intended systemic treatment for locoregionally advanced head and neck cancer.
Participants who are receiving any other investigational agents.
Participants in whom signatera ctDNA is not measurable at baseline.
Parallel
Pembrolizumab
DrugA drug that binds to a protein called programmed cell death 1 (PD-1) to help immune cells kill cancer cells better. Pembrolizumab is used to treat many different types of cancer.
Carboplatin
DrugA chemotherapy drug used to treat cancer.
Paclitaxel
DrugA chemotherapy drug used to treat cancer.
Objective Response Rate of Participants as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Overall response rate with pembrolizumab in combination with circulating tumor DNA (ctDNA) chemotherapy among subjects with head and neck cancer. Response rate will be defined as the proportion of participants with a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
The Rate of Adverse Events Reported Among Study Participants Receiving Pembrolizumab + Chemotherapy Compared to The Rate of Adverse Events Reported Among Participants Who Received Pembrolizumab + Chemotherapy in a Related Study
The rate of adverse events (Grade 3 of higher) reported among participants who receive pembrolizumab + chemotherapy compared to the rate of adverse events (Grade 3 or higher) reported among participants who received pembrolizumab +chemotherapy in a previous related study called Keynote-48. Adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Progression Free Survival of Participants Receiving Pembrolizumab + Chemotherapy
Progression Free Survival of pembrolizumab combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy among participants. Progression free survival will be defined as the time from date of first dose of study drug to date of documented progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors version 1.1 ( RECIST v1.1 )or death, whichever occurs first.
Overall Survival of Participants Receiving Pembrolizumab + Chemotherapy
The overall survival of pembrolizumab in combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy in participants with head and neck cancer. Overall survival will be defined as the time from the date of first dose of study drug to the date of death.
Duration of Response of Participants Receiving Pembrolizumab + Chemotherapy
The duration of response (DoR) of pembrolizumab in combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy in participants with head and neck cancer. Duration of response will be defined as the time from date of first documented response to the date of documented progressive disease or death, based on Response Evaluation Criteria in Solid Tumors version 1.1 ( RECIST v1.1).
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