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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: 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

Study ID: NCT04988074

Conditions

HPV-Related Squamous Cell Carcinoma

Interventions

Cemiplimab

Study Description

Brief 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).