Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04988074
Phase
PHASE2
Status
Recruiting
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Conditions

  • HPV-Related Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Cemiplimab for 9 weeks +/- Carboplatin + Paclitaxel

Study Details

To determine if it is feasible to use neoadjuvant immunotherapy (or immunotherapy plus chemotherapy) to reduce treatment intensity and improve long-term quality of life while maintaining very high cure rates.

Key Dates

Start date
Dec 13, 2021
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: De-Escalated Therapy
    Surgery (TORS) or Low-dose Radiation Therapy (42 Gy)
  • Experimental: Non/Minimally De-Escalated Therapy
    Surgery + Post-Operative Radiation Therapy (PORT) or 60 Gy Chemo-Radiation Therapy (CRT)

Primary Outcome Measure

2-year progression free survival rate [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287
Zubair Khan
[email protected]
410-955-3157
Sydjea Stillwell
[email protected]
410-614-9231
Nyall R London, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins University· Baltimore, MD

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