RecruitingPhase 2NCT05977907

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

Neoadjuvant Pembrolizumab and IO102-103 Prior to Curative-intent Surgical Care for Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

30 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — pembrolizumab and IO102-103 — given before surgery (neoadjuvant) for people with resectable (surgically removable) squamous cell carcinoma of the head and neck. The goal is to shrink the tumor before surgery and potentially improve long-term outcomes. **You may be eligible if...** - You are 18 or older - You have squamous cell carcinoma of the head and neck that is not bulky and can be surgically removed - Your cancer stage is generally T1N1–N2b or T2–T4 N0–N2b (your surgeon will confirm eligibility) - You are healthy enough to undergo surgery **You may NOT be eligible if...** - Your cancer is not surgically removable - You are unable to provide written informed consent - You do not meet health requirements for surgery or immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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