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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT05977907
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is an investigational drug in this study
  • IO102-103 — DRUG
    IO102-103 is an investigational drug in this study.

Study Details

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.

Key Dates

First listed
Aug 7, 2023
Start date
Dec 14, 2023
Status verified
Feb 2026
Primary completion
Oct 16, 2026
Completion
Oct 16, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Cohort
    Neoadjuvant Pembrolizumab ( 400mg IV infusion x1) + IO102-103 ( Subcutaneous injection weekly x6) Adjuvant Pembrolizumab ( 400 mg IV infusion Every 6 weeks x8) + IO102-103 ( Subcutaneous injection every 3 week x6 then every 6 weeks x5)

Primary Outcome Measure

Pathologic Treatment Response rate [ Time Frame: From neoadjuvant therapy to surgical resection, up to 6 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Karim Boudadi, MD
Northwestern Memorial HospitalChicagoIllinois60611
Jochen Lorch, MD
Johns Hopkins UniversityBaltimoreMaryland21287
Tanguy Seiwert, M.D
[email protected]
443-287-8312
Zubair Khan, M.D.
[email protected]
410-955-3157
Providence Cancer InstitutePortlandOregon97213
Rom Leidner, MD
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Adam Luginbuhl, MD

Find similar trials in Washington D.C., DC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Sibley Memorial Hospital· Washington D.C., DCNorthwestern Memorial Hospital· Chicago, ILJohns Hopkins University· Baltimore, MDProvidence Cancer Institute· Portland, ORThomas Jefferson University Hospital· Philadelphia, PA

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