NCT04988074

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible patients will receive 3 cycles/9 weeks of Cemiplimab (IV infusion) prior to curative treatment, with or without Carboplatin/Paclitaxel. The addition of carboplatin and paclitaxel depends on the presence of measurable benefit to participant. Assessments of patient progress are conducted weekly by multidisciplinary team and at week 9 or 10 a de-escalation decision will also be used to determine if patient receives de-escalated or non-minimally de-escalated treatment. De-Escalated Treatment: Transoral Robotic Surgery (TORS) or Low Dose Radiation Therapy (42Gy) Non-Minimally De-Escalated Treatment: Surgery + Post-Operative Radiation Therapy or 60 Gy Chemoradiation Therapy Curative intent will be followed by adjuvant Cemiplimab for 4 months (5 doses every 21 days).

Conditions

• HPV-Related Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	Cemiplimab for 9 weeks +/- Carboplatin + Paclitaxel

Timeline

• Start date: 2021-12-13
• Primary completion: 2027-06-30
• Completion: 2027-12-01
• First posted: 2021-08-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study