HPV-Related Squamous Cell CarcinomaPhase 2MINIMANCT04988074
Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca
A Phase 2 study testing Cemiplimab in people with HPV-Related Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-Related Squamous Cell Carcinoma
- What is being tested?
- Cemiplimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
- HPV testing must be compliant with the following criteria:
- p16 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 PCR, HPV cfDNA) before or during the neoadjuvant phase.*
- HPV DNA ISH is acceptable if positive, however a negative HPV DNA ISH should be confirmed by HPV RNA ISH or other nucleic acid based method.
- HPV16 type (non-HPV16 related cancers are not eligible)*
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- *In the rare event that a subject starts treatment based on p16 IHC alone and HPV type determination is not yet available, subject may commence neoadjuvant treatment based on p16 IHC alone, as along as HPV nucleic acid testing is pending. Patients with non-HPV16 associated tumors will have to leave the study. Given the prevalence of HPV16 (~90-95%) and usual rapid turnaround of HPV16 RNA-ISH (other assays) this is not expected, but the primary goal is not to have unnecessary treatment delay for subjects.
- Availability of ≥8 unstained 5 micron slides. Subjects who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study. In patients where biopsy is not safe, or logistically feasible this requirement can be waived by the PI or a lower number of slides can be accepted.
- Subjects must be at least 18 years of age.
- AJCC 7th edition: Stage III, IV without bulky N2b/c disease (defined as N3 equivalent volume) and without bulky T4 (≤30cc).
- (AJCC 8th edition: Stage II or III, or stage I with N1 or N2 nodes (>3cm or multiple), without bulky nodal disease (defined as N3 equivalent volume) and without bulky T4 disease (defined as 30cc tumor volume)).
- Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.
- No previous radiation or chemotherapy for a head and neck cancer.
- No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual disease is acceptable).
- ECOG performance status 0-1 (Karnofsky ³70%).
- Normal Organ Function
- Leukocytes ≥2500/mm3,
- Platelets ≥75,000/mm3,
- Absolute neutrophil count ≥1,500,
- Hemoglobin >9.0 gm/dL,
- AST and ALT <2.5 X ULN
- Alkaline phosphatase <2.5 X ULN
- Albumin >2.9 gm/dL,
- Total bilirubin ≤1.5 mg/dl,
- Creatinine clearance >45 mL/min (or SCr <1.6 mg/dL) within 4 weeks prior to start of treatment.
- The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate CrCl for enrollment or dosing
- Subjects must sign a study-specific informed consent form prior to study entry. Subjects should have the ability to understand and the willingness to sign a written informed consent document.
- Sex, and Reproductive Status:
- Women of childbearing potential (WOCBP=premenopausal woman capable of becoming pregnant) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- Women must not be breastfeeding.
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for up to 5 months post-treatment completion.
- Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for up to 7 months post treatment completion.
- Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.
Who cannot join
- Unequivocal demonstration of distant metastases (M1 disease).
- Unidentifiable/unknown primary site (neither imaging nor exam nor biopsy can identify the primary). Treating physicians should agree that the primary is sufficiently identified to proceed with clinical care/treatment (e.g. in the case of imaging localization, but absence of biopsy proven pathology)
- Intercurrent medical illnesses which would impair subject tolerance to therapy or limit survival. Including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Once clinically stable, as defined by the PI, they are eligible.
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns (please see above paragraph under inclusion criteria regarding WOCBP)
- Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment on study as outlined above
- Subjects receiving other investigational agents.
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- Peripheral neuropathy >grade 1
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active tuberculosis (Bacillus Tuberculosis infection)
- Has hypersensitivity to cemiplimab or any other drug used in this protocol.
- Has had a prior systemic anti-cancer treatment within the last 8 weeks
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or thyroid cancers, any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment other than hormonal therapies (e.g., adjuvant after breast cancer, or low grade prostate cancer).
- Has active autoimmune disease that has required systemic treatment in the past year (i.e., with use of steroids or immunosuppressive drugs). Replacement therapy e.g., levothyroxine, insulin, or physiologic corticosteroid doses for adrenal or pituitary insufficiency, etc. are not considered a form of systemic treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has a history of Human Immunodeficiency Virus (HIV) (HIV ½ antibodies).
- Has known active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). However, if eradicated subject is eligible.
- Has received a live vaccine within 28 days of planned start of study therapy.
- Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 28 days prior to initiation of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Zubair Khan, 410-955-3157, zkhan@jhmi.edu
Sydjea Stillwell, 410-614-9231, sstillw1@jhmi.edu
About this study
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
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.
Read the 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
- Being tested
- Cemiplimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called LIBTAYO
Cemiplimab for 9 weeks +/- Carboplatin + Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| De-Escalated Therapy | Experimental | Surgery (TORS) or Low-dose Radiation Therapy (42 Gy) Receives: Drug: Cemiplimab |
| Non/Minimally De-Escalated Therapy | Experimental | Surgery + Post-Operative Radiation Therapy (PORT) or 60 Gy Chemo-Radiation Therapy (CRT) Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression free survival rate
Measured: Up to 2 years
Change in Quality of life as measured by MD Anderson Dysphagia Inventory (MDADI)
The MD Anderson Dysphagia Inventory (MDADI) is a 20 item quality of life instrument specifically focusing on swallowing. The total score ranges from 20 to 100 with the higher score indicating higher level of function. Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree).
Measured: Up to 2 years
Change in quality of life as measured by the Sydney Swallow Questionnaire (SSQ).
The SSQ consists of 17 questions, (16 visual analogue scales (VAS) and one question scored on a Likert scale (0-5). The score for each VAS question is the distance in mm from the origin (left extremity) to the patient's mark on the visual analogue scale. The total score is calculated by summing the 16 individual VAS scores and the Likert scale (0-5) multiplied by 20. Thus converting the range of possible scores for Likert question from 0-5 to 0-100, consistent with the remaining 16 questions, to yield a total score out of a possible maximum of 1700. Higher scores indicate higher symptomatic severity of oral-pharyngeal dysphagia.
Measured: Up to 2 years
Change in swallow function as measured by the Sydney Swallow Questionnaire (SSQ).
Desirable swallowing function at 1 year for this study will be defined as SSQ ≤ 250 and MDADI ≥ 70
Measured: Up to 2 years
Change in swallow function as measured by the MD Anderson Dysphagia Inventory.
Desirable swallowing function at 1 year for this study will be defined as SSQ ≤ 250 and MDADI ≥ 70
Measured: Up to 2 years
Secondary outcomes (6)
To determine 2-year overall survival (OS) for the entire cohort
OS will be estimated by Kaplan-Meier methodology and comparisons will be made using the log-rank test. OS is defined as the time between the date of registration and the date of death.
Measured: From the date of registration to the date of death or date of last follow-up, up to 2 years
To determine 2-year rates of locoregional and distant control for the entire cohort
Locoregional and distant control will be assessed by immune response criteria using Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1
Measured: Time of registration to time of disease progression in head and neck or below clavicles for distant failure, assessed up to two years
Number of grade 3 toxicities
We will report the number of grade 3 toxicities using Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 100 days after last dose of study drug(s).
Number of grade 4 toxicities
We will report the number of grade 4 toxicities using Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 100 days after last dose of study drug(s).
Number of grade 3 Immune-related adverse events (irAE)
We will report the number of 3 Immune-related adverse events (irAE) using Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 100 days after last dose of study drug(s).
Number of grade 4 Immune-related adverse events (irAE)
We will report the number of grade 4 Immune-related adverse events (irAE) using Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 100 days after last dose of study drug(s).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start13 Dec 2021
- Primary completion30 Jun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nyall R London, M.D., Principal investigator, Johns Hopkins University/Sidney Kimmel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988074
- Sponsor's protocol ID
- J20118
- Other IDs
- IRB00259330
- Acronym
- MINIMA
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04988074
- Acronym / sponsor ID
- MINIMA / J20118
- Conditions
- HPV-Related Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-Escalated Therapy | Experimental | Drug: CemiplimabSurgery (TORS) or Low-dose Radiation Therapy (42 Gy) |
| Non/Minimally De-Escalated Therapy | Experimental | Drug: CemiplimabSurgery + Post-Operative Radiation Therapy (PORT) or 60 Gy Chemo-Radiation Therapy (CRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Subjects must have pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
- HPV testing must be compliant with the following criteria:
- HPV16 type (non-HPV16 related cancers are not eligible)*
- Availability of ≥8 unstained 5 micron slides. Subjects who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study. In patients where biopsy is not safe, or logistically feasible this requirement can be waived by the PI or a lower number of slides can be accepted.
- Subjects must be at least 18 years of age.
Key exclusion criteria (18 listed)
- Unequivocal demonstration of distant metastases (M1 disease).
- Unidentifiable/unknown primary site (neither imaging nor exam nor biopsy can identify the primary). Treating physicians should agree that the primary is sufficiently identified to proceed with clinical care/treatment (e.g. in the case of imaging localization, but absence of biopsy proven pathology)
- Intercurrent medical illnesses which would impair subject tolerance to therapy or limit survival. Including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Once clinically stable, as defined by the PI, they are eligible.
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns (please see above paragraph under inclusion criteria regarding WOCBP)
- Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment on study as outlined above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: LIBTAYOCemiplimab for 9 weeks +/- Carboplatin + Paclitaxel | Drug | De-Escalated Therapy, Non/Minimally De-Escalated Therapy |
Primary outcome
2-year progression free survival rate
Time frame: Up to 2 years
Change in Quality of life as measured by MD Anderson Dysphagia Inventory (MDADI)
Time frame: Up to 2 years
The MD Anderson Dysphagia Inventory (MDADI) is a 20 item quality of life instrument specifically focusing on swallowing. The total score ranges from 20 to 100 with the higher score indicating higher level of function. Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree).
Change in quality of life as measured by the Sydney Swallow Questionnaire (SSQ).
Time frame: Up to 2 years
The SSQ consists of 17 questions, (16 visual analogue scales (VAS) and one question scored on a Likert scale (0-5). The score for each VAS question is the distance in mm from the origin (left extremity) to the patient's mark on the visual analogue scale. The total score is calculated by summing the 16 individual VAS scores and the Likert scale (0-5) multiplied by 20. Thus converting the range of possible scores for Likert question from 0-5 to 0-100, consistent with the remaining 16 questions, to yield a total score out of a possible maximum of 1700. Higher scores indicate higher symptomatic severity of oral-pharyngeal dysphagia.
Change in swallow function as measured by the Sydney Swallow Questionnaire (SSQ).
Time frame: Up to 2 years
Desirable swallowing function at 1 year for this study will be defined as SSQ ≤ 250 and MDADI ≥ 70
Change in swallow function as measured by the MD Anderson Dysphagia Inventory.
Time frame: Up to 2 years
Desirable swallowing function at 1 year for this study will be defined as SSQ ≤ 250 and MDADI ≥ 70
6 secondary outcomes
To determine 2-year overall survival (OS) for the entire cohort
Time frame: From the date of registration to the date of death or date of last follow-up, up to 2 years
To determine 2-year rates of locoregional and distant control for the entire cohort
Time frame: Time of registration to time of disease progression in head and neck or below clavicles for distant failure, assessed up to two years
Number of grade 3 toxicities
Time frame: 100 days after last dose of study drug(s).
Number of grade 4 toxicities
Time frame: 100 days after last dose of study drug(s).
Number of grade 3 Immune-related adverse events (irAE)
Time frame: 100 days after last dose of study drug(s).
Number of grade 4 Immune-related adverse events (irAE)
Time frame: 100 days after last dose of study drug(s).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nyall R London, M.D. principal investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab in people with HPV-Related Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zubair Khan, M.D. (410-955-3157, zkhan@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression free survival rate (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.