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

Study acronym: MINIMA
StatusRecruiting
PhasePhase 2
Started2021-12-13
View on ClinicalTrials.gov ↗

Amendment history

2026-02-27
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2025-12-08
Study Status, Contacts/Locations v8
Primary completion date2025-11-12→2027-06-30
Completion date2026-08→2027-12
2024-12-12
Study Status v7
Primary completion date2024-11→2025-11-12
2024-03-01
Study Status v6
Re-verified, no change to tracked fields
2023-02-20
Study Status, Eligibility v5
Eligibility criteria+747 characters
[...] testing must be compliant with the following criteria: p16 immunohistochemistry (IHC) positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al89). p16 IHC positivity is to be validated using an HPV nucleic acid based secondary assay (HPV ISH, HPV polymerase chain reaction (PCR), HPV ctDNAcfDNA) before or during the neoadjuvant phase.* HPV DNA in situ hybridization (ISH) is acceptable if positive, however a negative HPV DNA ISH s [...] hod. HPV16 type (non-HPV16 related cancers are not eligible)* *In the rare event that a subjec [...] [...]
Show 4 earlier versions
2023-01-09
Study Status, Contacts/Locations v4
Re-verified, no change to tracked fields
2022-01-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-12→confirmed 2021-12-13
Study sites0→1
2021-11-18
Study Status v2
Start date2021-10→2021-12
2021-09-24
Study Status v1
Primary completion date2024-08→2024-11
Start date2021-08→2021-10
2021-07-23
Original filing
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.
Trial Details
NCT Number NCT04988074
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Regeneron Pharmaceuticals
Conditions HPV-Related Squamous Cell Carcinoma
Enrollment 32 participants
Start Date 2021-12-13
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-03