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Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC

NCT06052839 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

  • Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Interventions

DRUG

Pembrolizumab

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.

DRUG

Carboplatin

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.

DRUG

Paclitaxel

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

Sponsors & Collaborators

  • Dan Zandberg

    lead OTHER

Principal Investigators

  • Dan P Zandberg, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052839 on ClinicalTrials.gov