RecruitingPhase 2

Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).

United States30 participantsStarted 2023-12-14

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Surgically resectable disease - generally that is T1N1-N2B, T2-4N0-N2b stage are generally eligible (AJCC 7th), however exceptions can be made after approval by the PI for surgically appropriate cases.
✓. If determined per tumor board that a low-volume/non-bulky tumor of another stage is appropriate for resection (e.g. small volume T4 with a small amount of bone invasion) such tumors may also be considered for this study if recommendation in tumor board is such.
✓. Abstinence is considered an adequate contraception method.

What they're measuring

Pathologic Treatment Response rate

Timeframe: From neoadjuvant therapy to surgical resection, up to 6 weeks

Trial details

NCT IDNCT05977907

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-16

Contact for this trial

Wojciech K Mydlarz, M.D., FACS

(301) 896-3332 mydlarz@jhmi.edu

View on ClinicalTrials.gov More Head and Neck Squamous Cell Carcinoma trials