CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 32 target
Drug / intervention
Cemiplimabdrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx
  • ✓HPV16 type (non-HPV16 related cancers are not eligible)
  • ✓p16 IHC positivity sufficient for enrollment, validated with HPV nucleic acid assay before or during neoadjuvant phase
  • ✓Stage III-IV (AJCC 7th) or Stage II-III/I with N1-N2 (AJCC 8th) without bulky N2b/c or T4 disease
Key exclusion· 17
  • ✕Distant metastases (M1 disease)
  • ✕Unidentifiable/unknown primary site
  • ✕Prior systemic anti-cancer treatment within last 8 weeks
  • ✕Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04988074
NCT04988074Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
CompareCT.gov

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 3, 2021·Updated Mar 3, 2026

In Brief

A Phase 2 clinical trial evaluating Cemiplimab for HPV-Related Squamous Cell Carcinoma. Currently recruiting, targeting 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHPV-Related Squamous Cell Carcinoma
CountriesUnited States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 2Recruiting
2022202320242025202620272028
First PostedAug 3, 2021
Enrollment StartDec 13, 2021
Primary CompletionJun 30, 2027
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 4.9 years agoPrimary completion in 12 months

Interventions

Cemiplimabdrug

Cemiplimab for 9 weeks +/- Carboplatin + Paclitaxel