Actively Recruiting
Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC
Led by Dan Zandberg · Updated on 2026-02-09
15
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
- PD-L1 Combined Positive Score (CPS) greater than 1
- Age over 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Measurable disease using RECIST 1 criteria
- Normal organ and marrow function as defined by specific blood counts and liver and kidney tests
- Negative pregnancy test for females of childbearing potential before starting treatment
- Willingness of females of childbearing potential to use birth control or abstain from heterosexual activity during the study and for 60 days after
- Agreement by male participants to use contraception during the study and for 60 days after
- Ability to understand and sign informed consent
- No active brain disease if prior brain metastases are known, confirmed by MRI or CT within 30 days of consent
You will not qualify if you...
- Prior systemic therapy alone for recurrent or metastatic disease, except platinum-based systemic therapy completed more than 6 months ago as part of curative treatment for locally advanced disease
- Prior anti-PD-1 or anti-PD-L1 antibody therapy for recurrent or metastatic disease within the past year
- Squamous cell carcinoma of the skin or salivary gland origin
- Active autoimmune disease requiring systemic treatment within the past 3 months or need for ongoing systemic steroids or immunosuppressants, with some exceptions
- History of non-infectious pneumonitis requiring steroids, interstitial lung disease, or active non-infectious pneumonitis
- Another cancer within 2 years that might affect study outcomes
- Peripheral sensory neuropathy greater than grade 2
- Any condition or abnormality that might interfere with study participation or affect results
- Known allergy or hypersensitivity to carboplatin, platinum agents, pembrolizumab, or paclitaxel
- Baseline neutrophil count below 1,500 cells/mm
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
J
Jennifer Ruth, RN, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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