RecruitingPhase 2NCT06052839

Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC

Phase II Trial of Pulsed Dose Chemotherapy Plus Pembrolizumab in the First Line Treatment of Recurrent/Metastatic HNSCC


Sponsor

Dan Zandberg

Enrollment

15 participants

Start Date

Oct 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The rationale for the new sequence of pulsed dose chemotherapy proposed in this trial is based on the hypotheses that current standard dosing of chemotherapy plus pembrolizumab ultimately suppresses the immune system and has a negative effect on the efficacy of the anti-PD-1 monoclonal antibody (mAb) therapy and that chemotherapy given after anti-PD-1 mAb therapy is associated with higher efficacy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new chemotherapy dosing strategy — short, pulsed doses at regular intervals rather than continuous cycles — combined with the immunotherapy drug pembrolizumab, for head and neck squamous cell carcinoma (HNSCC) that has returned or spread and cannot be cured by surgery or radiation. **You may be eligible if...** - You have recurrent or metastatic squamous cell carcinoma of the head and neck that is no longer curable by local treatment - Your tumor tests positive for PD-L1 (CPS score greater than 1) - You are 18 or older and in acceptable overall health - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - You have active autoimmune disease or are on long-term immunosuppressants - You have had prior pembrolizumab or other anti-PD-1/PD-L1 immunotherapy - You have uncontrolled brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Immunotherapy that works by helping the immune system to kill cancer cells by targeting and blocking a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.

DRUGCarboplatin

A chemotherapy drug that contains the metal platinum. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA.

DRUGPaclitaxel

A chemotherapeutic agent used as a treatment for various cancers; paclitaxel is a mitotic inhibitor.


Locations(1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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NCT06052839