RecruitingPhase 2NCT04988074

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

A Phase II Trial of Cemiplimab, or Cemiplimab-Chemotherapy, Followed by Biomarker-guided De-escalated Curative-intent Locoregional Treatment for Patients With Advanced HPV-related Head and Neck Cancer. The MINIMA Study

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

32 participants

Start Date

Dec 13, 2021

Study Type

INTERVENTIONAL

Conditions

HPV-Related Squamous Cell Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an immunotherapy-based treatment strategy for people with HPV-positive head and neck squamous cell carcinoma of the oropharynx (throat cancer caused by the HPV16 virus). Patients first receive cemiplimab (an immunotherapy) alone or with chemotherapy, and then treatment is adjusted based on how their tumor responds. **You may be eligible if...** - You have confirmed HPV16-positive squamous cell carcinoma of the oropharynx or a nearby throat structure - Your tumor is Stage II or III (or specific Stage I with lymph node involvement) by current staging criteria - You are 18 or older - Your tumor is not excessively large or bulky **You may NOT be eligible if...** - Your cancer is not HPV16-associated - Your tumor is HPV-negative on confirmatory testing - Your tumor is very large or bulky (defined as N3 equivalent or T4 above 30cc) - You are not able or willing to provide tissue samples for testing 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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