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Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN). | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT05977907•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be willing and able to provide written informed consent/assent for the trial.
•Be 18 years of age on day of signing informed consent.
•Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck, with an indication for surgical therapy.
•1. 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.
•2. 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.
•Be appropriate candidates for resection and curative intent therapy in general.
•Have a performance status of 0 or 1 on the ECOG Performance Scale.
•Consent to undergo biopsy from a newly obtained core or excisional biopsy of a tumor lesion before study drug administration, and during treatment. Biopsy in case of progressive disease is optional.
•Demonstrate adequate organ function
•Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
+3 more criteria

Exclusion Criteria

•A Women of child bearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to treatment allocation/registration . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
•Has received prior systemic anti-cancer therapy for HNSCC including investigational agents within 4 weeks of first dose of study treatment.
•Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non- Central nervous system (CNS) disease.
•Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug (including live COVID-19 vaccines). Administration of killed vaccines is allowed. Administration of messenger RNA (mRNA) or peptide vaccines (e.g., for COVID-19) is allowed.
•Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
•Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, low grade cancers that are not expected to impact life expectancy within the next 3 years and not impact interpretation of this study are allowed
•Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging
•Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
+11 more criteria

Locations (5)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Providence Cancer Institute

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 14, 2023

Primary Completion Date

October 16, 2026

Completion Date

October 16, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Pembrolizumab

DRUG

IO102-103

DRUG

Contacts

Wojciech K Mydlarz, M.D., FACS

CONTACT

(301) 896-3332 mydlarz@jhmi.edu

Zubair Khan, M.D.

CONTACT

410-955-3157 zkhan@jhmi.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation