HNSCCPhase 2NCT04169074
Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial)
A Phase 2 study testing Abemaciclib in people with HNSCC, run by University of Arizona at 2 sites in United States.
Trial summary
This is a Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HNSCC
- What is being tested?
- Abemaciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2021to 13 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cytologic or histologic diagnosis of squamous cell carcinoma of the oral cavity, p16-negative oropharynx, hypopharynx, or larynx.
- Tumors must be HPV-negative. For eligibility, tumors of the oral cavity, hypopharynx, or larynx will be considered HPV-negative without specialized testing. Tumors of the oropharynx must be HPV-negative as determined by p16 immunohistochemistry and/or HPV-DNA per local standard.
- Clinical stage I-IVa based upon the American Joint Committee on Cancer (AJCC) staging manual, 8th edition.
- Appropriate and planned for oncologic resection of the primary tumor and/or neck dissection.
- Clinically or radiologically measurable disease; the primary tumor and/or cervical nodes may be measurable according to RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper/ruler measurement (tumor diameter ≥ 1 cm).
- No prior treatment for the index (study-qualifying) HNSCC.
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- Patients with two simultaneous primary tumors or bilateral tumors are included.
- The index HNSCC may be a second primary HNSCC, provided the following criteria are met:
- The previously treated HNSCC was treated with curative intent. b. The index HNSCC is at least 1 cm from the previously treated HNSCC. c. At least 2 years have elapsed since curative treatment of the previous HNSCC without evidence for recurrence.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1. (See Appendix 1.)
- Adequate hematologic function, as defined by:
- Absolute neutrophil count (ANC) ≥ 1,500/µl b. Platelets ≥ 100,000/µl c. Hemoglobin ≥ 8 g/dL
- Adequate liver function, as defined by:
- Bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 x ULN and direct bilirubin within normal limits are permitted.
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
- Adequate renal function, as defined by creatinine ≤ 1.5 x ULN.
- Able to swallow oral medications.
- Have signed written informed consent.
- Consent to biomarker collection requirements, including mandatory baseline and intra-operative research biopsies of the index tumor.
Who cannot join
- Prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor or anti-programmed death (PD)-1/L1 inhibitor is not allowed.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned protocol treatment. The following are exceptions to this criterion unless otherwise indicated:
- Intranasal, inhaled, or topical steroids, or local steroid injections (eg, intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT premedication) and/or as anti-emetics
- Active or previously documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). The following are exceptions to this criterion:
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- Patients with vitiligo or alopecia
- Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Subclinical hypothyroidism (eg. Elevated thyroid-stimulating hormone (TSH), low or normal free T4, and asymptomatic) observed on screening labs is not an exclusion.
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study PI
- Patients with celiac disease controlled by diet alone
- Patient has a personal history of any of the following cardiac or pulmonary abnormalities:
- Syncope of cardiovascular etiology
- Ventricular arrhythmia of pathologic origin (including, but limited to, ventricular tachycardia and ventricular fibrillation)
- Sudden cardiac arrest
- Documented history of New York Heart Association functional classification III-IV congestive heart failure
- Myocardial infarction ≤ 6 months prior to enrollment
- Current unstable angina pectoris
- Interstitial lung disease
- Severe dyspnea at rest or requiring oxygen therapy
- Patient with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral abemaciclib (e.g. history of major surgical resection involving the stomach or small bowel, malabsorption syndrome, preexisting Crohn's disease or ulcerative colitis, preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Patients who require the chronic administration of drugs that are strong and moderate inducers of Cytochrome P450, family 3, subfamily A, (CYP3A) and/or strong inhibitors of CYP3A, and no acceptable substitute can be identified, are not eligible for study (See Appendix 2). Such drugs should be discontinued at least 7 days before the start of study treatment.
- The patient has active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or known active hepatitis B or C [e.g. hepatitis B surface antigen positive or hepatitis C antibody positive with detectable viral load]). Screening for HIV or hepatitis is not required for enrollment.
- Patient with any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. social/psychological complications.
- Pregnant or nursing (lactating) women.
- Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:
- Sexually active males should use a condom during intercourse while taking abemaciclib and for 4 weeks after the final dose of abemaciclib.
- Males who are sexually active with a woman of child-bearing potential should apply highly effective contraception during the study as defined below, in order not to father a child in this period.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 3 weeks after the final dose of abemaciclib. Highly effective contraception is defined as:
- Total abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception].
- Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
- Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female study subjects, the vasectomized male partner should be the sole partner for that patient.] iv. Use a combination of the following (both 1+2):
- 1. Placement of an intrauterine device (IUD) or intrauterine system (IUS) 2. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- Note: Hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed as abemaciclib may decrease the effectiveness of hormonal contraceptives.
- Note: Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
- 11. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Arizona
Tucson, Arizona, 85719
George Washington Cancer Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Immune Modulation by Abemaciclib in HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase II Window Trial.
This is a Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).
Read the detailed description
This is a Phase II single-arm window trial to assess the clinical and biological effects of 10-21 days of neoadjuvant abemaciclib in patients with HPV-negative HNSCC who are planned for oncologic surgery, with pre-clinically informed genetic and immune biomarker correlatives.
In the window-of-opportunity clinical trial, patients planned for oncologic surgery are briefly exposed to a novel cancer agent in the window between diagnostic biopsy and definitive surgery. Paired, pre- and post-surgical tumor specimens permit ex vivo analysis of target modulation in both tumor and the tumor microenvironment - providing insight into mechanism of action and paving the way for rigorous companion biomarker development. Clinical activity is assessed by quantitative change in tumor size (∆T), which is correlated to hypothesis-driven genomic and immune biomarkers of interest.
Investigators hypothesize that abemaciclib will significantly reduce tumor burden as measured by ∆T. Further, investigators will test the primary biomarker hypothesis that the clinical activity of abemaciclib is associated with an increased proportion of tumors that are T-cell inflamed. Investigators will evaluate tumor-intrinsic, tumor microenvironment (TME), and microbiome biomarker hypotheses in specific genetic contexts, including tumors with specific classes of tumor protein 53 (TP53) mutations, p16 loss, and/or CCND1 amplification.
- Conditions
- HNSCC
- Being tested
- Abemaciclib
- Keywords
- Head and Neck Cancer, HNSCC, Squamous Cell Cancer, abemaciclib
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Treatment will consist of a single neoadjuvant cycle of 10-21 days (+7 days). Abemaciclib will be administered from days 1-21. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with abemaciclib | Experimental | Treatment will consist of a single neoadjuvant cycle of 10-21 days (+7 days if needed due to surgical delay). Abemaciclib will be administered from days 1-21. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery. Abemaciclib 200 mg PO twice daily on Days 1-21 (+7 days). Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Quantitative Change in Tumor Size to Assess the Clinical Activity of Abemaciclib.
To evaluate the clinical activity of abemaciclib in patients with operable, HPV-negative HNSCC as measured by quantitative change in tumor size (∆T) following 10-21 (+7) days of neoadjuvant exposure. ∆T will be measured as a continuous variable, based upon the percent change in RECIST v1.1 metrics for index lesions. Index lesions will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumor (RECIST) Committee.
Measured: This outcome measure will be assessed at baseline and post 10-21 (+7) days of neoadjuvant exposure to abemaciclib.
Secondary outcomes (1)
Describe the Safety and Tolerability of Neoadjuvant Exposure to Abemaciclib in Accordance With NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.
To describe the safety and tolerability of neoadjuvant exposure to abemaciclib in accordance with NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start7 Jul 2021
- Primary completion16 Dec 2024
- Study completion13 Jan 2025
Why it stopped: Standard of care therapy for Stage III-IVA HNSCC updated in June to include neoadjuvant + adjuvant immunotherapy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HNSCCStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label Phase II single-arm window trial.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University
- Responsible party
- Sponsor
- Investigators
- Ricklie Julian, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169074
- Sponsor's protocol ID
- 1906702171
- Status last verified
- May 2026
- First submitted
- 15 Apr 2019
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Modulation by Abemaciclib in HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase II Window Trial.
- ClinicalTrials.gov ID
- NCT04169074
- Acronym / sponsor ID
- 1906702171
- Conditions
- HNSCC
- Keywords
- Head and Neck Cancer, HNSCC, Squamous Cell Cancer, abemaciclib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Standard of care therapy for Stage III-IVA HNSCC updated in June to include neoadjuvant + adjuvant immunotherapy.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- George Washington University
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).
Detailed description
This is a Phase II single-arm window trial to assess the clinical and biological effects of 10-21 days of neoadjuvant abemaciclib in patients with HPV-negative HNSCC who are planned for oncologic surgery, with pre-clinically informed genetic and immune biomarker correlatives.
In the window-of-opportunity clinical trial, patients planned for oncologic surgery are briefly exposed to a novel cancer agent in the window between diagnostic biopsy and definitive surgery. Paired, pre- and post-surgical tumor specimens permit ex vivo analysis of target modulation in both tumor and the tumor microenvironment - providing insight into mechanism of action and paving the way for rigorous companion biomarker development. Clinical activity is assessed by quantitative change in tumor size (∆T), which is correlated to hypothesis-driven genomic and immune biomarkers of interest.
Investigators hypothesize that abemaciclib will significantly reduce tumor burden as measured by ∆T. Further, investigators will test the primary biomarker hypothesis that the clinical activity of abemaciclib is associated with an increased proportion of tumors that are T-cell inflamed. Investigators will evaluate tumor-intrinsic, tumor microenvironment (TME), and microbiome biomarker hypotheses in specific genetic contexts, including tumors with specific classes of tumor protein 53 (TP53) mutations, p16 loss, and/or CCND1 amplification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label Phase II single-arm window trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment with abemaciclib | Experimental | Drug: AbemaciclibTreatment will consist of a single neoadjuvant cycle of 10-21 days (+7 days if needed due to surgical delay). Abemaciclib will be administered from days 1-21. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery. Abemaciclib 200 mg PO twice daily on Days 1-21 (+7 days). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Cytologic or histologic diagnosis of squamous cell carcinoma of the oral cavity, p16-negative oropharynx, hypopharynx, or larynx.
- Tumors must be HPV-negative. For eligibility, tumors of the oral cavity, hypopharynx, or larynx will be considered HPV-negative without specialized testing. Tumors of the oropharynx must be HPV-negative as determined by p16 immunohistochemistry and/or HPV-DNA per local standard.
- Clinical stage I-IVa based upon the American Joint Committee on Cancer (AJCC) staging manual, 8th edition.
- Appropriate and planned for oncologic resection of the primary tumor and/or neck dissection.
- Clinically or radiologically measurable disease; the primary tumor and/or cervical nodes may be measurable according to RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper/ruler measurement (tumor diameter ≥ 1 cm).
Key exclusion criteria (36 listed)
- Prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor or anti-programmed death (PD)-1/L1 inhibitor is not allowed.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned protocol treatment. The following are exceptions to this criterion unless otherwise indicated:
- Active or previously documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). The following are exceptions to this criterion:
- Patient has a personal history of any of the following cardiac or pulmonary abnormalities:
- Patient with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral abemaciclib (e.g. history of major surgical resection involving the stomach or small bowel, malabsorption syndrome, preexisting Crohn's disease or ulcerative colitis, preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
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 |
|---|---|---|
| AbemaciclibTreatment will consist of a single neoadjuvant cycle of 10-21 days (+7 days). Abemaciclib will be administered from days 1-21. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery. | Drug | Treatment with abemaciclib |
Primary outcome
Measure Quantitative Change in Tumor Size to Assess the Clinical Activity of Abemaciclib.
Time frame: This outcome measure will be assessed at baseline and post 10-21 (+7) days of neoadjuvant exposure to abemaciclib.
To evaluate the clinical activity of abemaciclib in patients with operable, HPV-negative HNSCC as measured by quantitative change in tumor size (∆T) following 10-21 (+7) days of neoadjuvant exposure. ∆T will be measured as a continuous variable, based upon the percent change in RECIST v1.1 metrics for index lesions. Index lesions will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumor (RECIST) Committee.
1 secondary outcome
Describe the Safety and Tolerability of Neoadjuvant Exposure to Abemaciclib in Accordance With NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.
Time frame: Two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
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FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
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Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
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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. This study is not recruiting at the moment.
Ricklie Julian, MD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib in people with HNSCC, run by University of Arizona at 2 sites 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 19 inclusion and 36 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: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Quantitative Change in Tumor Size to Assess the Clinical Activity of Abemaciclib. (time frame: This outcome measure will be assessed at baseline and post 10-21 (+7) days of neoadjuvant exposure to abemaciclib.). 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 22 May 2026.