Actively Recruiting
A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER)
Led by University of Malaya · Updated on 2024-10-15
63
Participants Needed
1
Research Sites
323 weeks
Total Duration
On this page
Sponsors
U
University of Malaya
Lead Sponsor
C
Cancer Research Malaysia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, single-arm, Phase 2 study of pembrolizumab plus platinum and gemcitabine (PG) in subjects with recurrent or metastatic head and neck cancer squamous cell carcinoma (R/M HNSCC). Evaluable 63 subjects with R/M HNSCC will be enrolled for examination of the efficacy and safety of the combination of pembrolizumab (200 mg IV on Day 1 of each 3-week cycle, up to 35 cycles) in combination with platinum (either cisplatin at 35 mg/m2 IV using a split-dose regimen on Day 1 and Day 8 or carboplatin at AUC 5 IV on Day 1 of each 3-week cycle, up to 6 cycles) and gemcitabine at 1250 mg/m2 IV on Day 1 and 8 of each 3-week cycle, for up to 6 cycles as first-line treatment. This study will be conducted in conformance with Good Clinical Practices. Specific procedures to be performed during the trial, as well as their prescribed timelines and associated visit windows, are outlined in the protocol.
CONDITIONS
Official Title
A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma that cannot be cured by local therapies
- No prior systemic therapy for recurrent or metastatic disease within 6 months before consent; prior systemic therapy for locally advanced disease completed more than 6 months before consent allowed
- Primary tumor located in the oropharynx, oral cavity, hypopharynx, or larynx; nasopharynx location excluded
- Males must agree to use contraception during treatment and for 180 days after last dose; females must not be pregnant or breastfeeding and either not be of childbearing potential or agree to use contraception during treatment and for 180 days after last dose
- Willing and able to provide written informed consent
- Measurable disease based on RECIST 1.1 criteria
- Availability of archival or fresh tumor tissue for biomarker evaluation, preferably not previously irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as defined by specific blood count and chemistry criteria within 10 days prior to treatment start
You will not qualify if you...
- Disease suitable for curative local therapy
- Progressive disease within 6 months after curative treatment for locally advanced head and neck cancer
- Life expectancy less than 3 months
- Positive pregnancy test for women of childbearing potential prior to treatment
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor targeting agents
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks before study treatment
- Prior radiotherapy within 2 weeks before treatment, unless palliative radiation with specific conditions
- Receipt of live or live-attenuated vaccine within 30 days before first dose
- Participation in another investigational study within 4 weeks before first dose
- Immunodeficiency or ongoing immunosuppressive therapy exceeding specified doses
- Known progressing malignancy requiring active treatment within past 5 years, except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known history of HIV, active Hepatitis B or C infection
- Conditions or therapies that could interfere with study results or participation
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnancy, breastfeeding, or intent to conceive/father children during study duration
- History of allogenic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
Research Team
W
Wan Zamaniah Wan Ishak, MBBS, MD
CONTACT
S
Suganiya Rama Rao
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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