Actively Recruiting
Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-03-03
30
Participants Needed
5
Research Sites
252 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
I
IO Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is being done to see if it is safe to give investigational combination of study drugs (Pembrolizumab and IO102-103) before surgery to people with surgically resectable (removable) newly diagnosed or recurrent metastatic SCCHN. This will be done by watching participants closely for possible side effects from Pembrolizumab and IO102-103. In addition, participants will be monitored for any delays to their surgery due to the study drugs.
CONDITIONS
Official Title
Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent for the trial
- 18 years of age or older on the day of signing informed consent
- Diagnosed with non-bulky squamous cell carcinoma of the head and neck suitable for surgical removal
- Surgically resectable disease generally at stages T1N1-N2B, T2-4N0-N2b (AJCC 7th), with possible exceptions approved by the principal investigator
- Tumors at other stages may be eligible if approved by tumor board as appropriate for surgery
- Appropriate candidates for surgery and curative intent therapy
- ECOG Performance Status of 0 or 1
- Consent to biopsy before study drug administration and during treatment
- Adequate organ function
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Female participants of childbearing potential must use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study through 120 days after last dose
- Male participants must agree to use adequate contraception or abstinence from first dose through 120 days after last dose
You will not qualify if you...
- Female participants of childbearing potential with a positive pregnancy test within 72 hours before treatment
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint agents
- Prior systemic anti-cancer therapy for head and neck squamous cell carcinoma within 4 weeks before first dose
- Prior radiotherapy within 2 weeks before study treatment start, with exceptions for certain palliative radiation
- Receipt of live or live-attenuated vaccines within 30 days before first dose; killed and mRNA vaccines allowed
- Participation in another investigational agent or device study within 4 weeks before first dose
- Diagnosis of immunodeficiency or use of high-dose systemic steroids or immunosuppressive therapy within 7 days before first dose
- Active progressing additional malignancies requiring treatment within past 2 years, except certain low-grade skin cancers
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years, with exceptions for certain steroid therapies
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known HIV, Hepatitis B, or Hepatitis C infection
- Conditions, therapies, or lab abnormalities interfering with participation or study results
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant or breastfeeding, or planning to conceive or father children during study and 120 days after
- History of allogenic tissue or solid organ transplant
- Serious uncontrolled cardiac conditions or recent heart attack or myocarditis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Not Yet Recruiting
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Providence Cancer Institute
Portland, Oregon, United States, 97213
Not Yet Recruiting
5
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
Research Team
W
Wojciech K Mydlarz, M.D., FACS
CONTACT
Z
Zubair Khan, M.D.
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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