A Phase 2 interventional study of Abemaciclib in HNSCC, sponsored by University of Arizona. Terminated at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Arizona · Phase 2, Interventional, and Treatment
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).
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.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 7 is below the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The index HNSCC may be a second primary HNSCC, provided the following criteria are met:
a. 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.
Adequate hematologic function, as defined by:
a. (ANC) ≥ 1,500/µl b. ≥ 100,000/µl c. ≥ 8 g/dL
Adequate liver function, as defined by:
a. ≤ 1.5 x institutional (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 x ULN and direct bilirubin within normal limits are permitted.
b. (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
Exclusion Criteria:
Current or prior use of 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 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 who does not apply highly effective during the study and through the duration as defined below after the final dose of study treatment:
i. 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].
ii. Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
iii. 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.
v. Note: Hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed as abemaciclib may decrease the effectiveness of hormonal contraceptives.
vi. Note: Women are considered 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Abemaciclib
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.
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.
Time frame: This outcome measure will be assessed at baseline and post 10-21 (+7) days of neoadjuvant exposure to abemaciclib.
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.
Time frame: Two months
Measure Interferon Gamma (IFN-ɣ) Gene Expression Signature in Baseline and Post-treatment Tumor Biopsies.
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including IFN-ɣ gene expression signature in baseline and post-treatment tumor biopsies. The primary biomarker hypothesis is that abemaciclib will increase the proportion of tumors that are T-cell inflamed.
Time frame: Two months
Measure Tumor-intrinsic Genetic Biomarkers Utilizing Tumor Specimen.
Evaluate tumor-intrinsic genetic biomarkers associated with ∆T, including somatic genetic or epigenetic alterations in CCND1, CDKN2A, and TP53 utilizing tumor specimen obtained during planned oncologic head and neck cancer surgery.
Time frame: Two months
Measure the Distribution of Tumor-infiltrating Immune Cell Subtypes and Their Activation Status, as Measured by Nanostring.
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including The distribution of tumor-infiltrating immune cell subtypes and their activation status, including lymphocytes and myeloid-derived stem cells, as measured by nanostring.
Time frame: Two months
Measure the Distribution of Tumor-infiltrating Immune Cell Subtypes and Their Activation Status, as Measured by Immunohistochemistry (IHC).
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including The distribution of tumor-infiltrating immune cell subtypes and their activation status, including lymphocytes and myeloid-derived stem cells, as measured by immunohistochemistry (IHC).
Time frame: Two months
Measure the Distribution of Tumor-infiltrating Immune Cell Subtypes and Their Activation Status, as Measured by Flow Cytometry.
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including The distribution of tumor-infiltrating immune cell subtypes and their activation status, including lymphocytes and myeloid-derived stem cells, as measured by flow cytometry.
Time frame: Two months
Measure the Distribution of Peripheral Immune Cell Subtypes and Their Activation Status
To evaluate the distribution of peripheral immune cell subtypes and their activation status, and how this is altered by abemaciclib.
Time frame: Two months
Measure How Serum Th1 and Th2 Cytokine Profiles Are Altered by Abemaciclib.
To evaluate serum Th1 and Th2 cytokine profiles, and how they are altered by abemaciclib.
Time frame: Two months
Measure Tumor-intrinsic Molecular Mediators of Response and Resistance to Abemaciclib.
Evaluate tumor-intrinsic molecular mediators of response and resistance to abemaciclib in baseline and post-treatment tumor biopsies, including expression of CDKN2A (p16), CCND1 (cyclin D1), and retinoblastoma tumor suppressor protein (pRB) retinoblastoma.
Time frame: Two months
Measure Change in the Proliferative Index (∆Ki67) in Pre- and Post-treatment Tumor Specimens.
Evaluate the anti-proliferative activity of abemaciclib as measured by change in the proliferative index (∆Ki67) in pre- and post-treatment tumor specimens.
Time frame: Two months
Describe Features of the Oral and Intestinal Microbiomes That Are Associated With the Clinical Activity of Abemaciclib.
To describe features of the oral and intestinal microbiomes that are associated with the clinical activity of abemaciclib.
Time frame: Two months
The recruitment period was 06/16/2021-08/29/2025. The first patient was enrolled 07/07/2021. The last patient was enrolled 12/02/2024. Patients were recruited from the investigators' current clinical practice at University of Arizona Cancer Center and George Washington Cancer Center. The study was closed prematurely due to a change in standard of care for this patient population that was FDA approved June 2025.
| Milestone | Treatment With Abemaciclib |
|---|---|
| Started | 7 |
| Completed | 4 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 2 |
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.
| % change | Treatment With Abemaciclib |
|---|---|
| Measure Quantitative Change in Tumor Size to Assess the Clinical Activity of Abemaciclib. | -0.01 ± 0.16 |
To describe the safety and tolerability of neoadjuvant exposure to abemaciclib in accordance with NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.
| Participants | Treatment With Abemaciclib |
|---|---|
| Patients with any AE of grade ≥ 3 | 2 |
| Patients with any serious AE | 2 |
| Patients with any AE possibly attributed to abemaciclib | 2 |
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including IFN-ɣ gene expression signature in baseline and post-treatment tumor biopsies. The primary biomarker hypothesis is that abemaciclib will increase the proportion of tumors that are T-cell inflamed.
Results for this outcome have not been posted.
Evaluate tumor-intrinsic genetic biomarkers associated with ∆T, including somatic genetic or epigenetic alterations in CCND1, CDKN2A, and TP53 utilizing tumor specimen obtained during planned oncologic head and neck cancer surgery.
Results for this outcome have not been posted.
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including The distribution of tumor-infiltrating immune cell subtypes and their activation status, including lymphocytes and myeloid-derived stem cells, as measured by nanostring.
Results for this outcome have not been posted.
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including The distribution of tumor-infiltrating immune cell subtypes and their activation status, including lymphocytes and myeloid-derived stem cells, as measured by immunohistochemistry (IHC).
Results for this outcome have not been posted.
Evaluate baseline and pharmacodynamic biomarkers within the TME associated with ∆T, including The distribution of tumor-infiltrating immune cell subtypes and their activation status, including lymphocytes and myeloid-derived stem cells, as measured by flow cytometry.
Results for this outcome have not been posted.
To evaluate the distribution of peripheral immune cell subtypes and their activation status, and how this is altered by abemaciclib.
Results for this outcome have not been posted.
To evaluate serum Th1 and Th2 cytokine profiles, and how they are altered by abemaciclib.
Results for this outcome have not been posted.
Evaluate tumor-intrinsic molecular mediators of response and resistance to abemaciclib in baseline and post-treatment tumor biopsies, including expression of CDKN2A (p16), CCND1 (cyclin D1), and retinoblastoma tumor suppressor protein (pRB) retinoblastoma.
Results for this outcome have not been posted.
Evaluate the anti-proliferative activity of abemaciclib as measured by change in the proliferative index (∆Ki67) in pre- and post-treatment tumor specimens.
Results for this outcome have not been posted.
To describe features of the oral and intestinal microbiomes that are associated with the clinical activity of abemaciclib.
Results for this outcome have not been posted.
Collected over Adverse event data was collected for each patient from the start of study drug to 4 weeks (+/- 1 week) after the last dose of study drug. For patients who completed the study this ranges from 10 days + 4 weeks (+/- 1 week) to 28 days + 4 weeks (+/1 week).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Abemaciclib | 0/7 (0%) | 2/7 (28.6%) | 6/7 (85.7%) |
| Event | Treatment With Abemaciclib |
|---|---|
| Myocardial InfarctionCardiac disorders | 1/7 |
| Surgical and medical procedures - Other, specify - flap graft failureSurgical and medical procedures | 1/7 |
| Thromboembolic eventVascular disorders | 1/7 |
| Skin infectionInfections and infestations | 1/7 |
| Event | Treatment With Abemaciclib |
|---|---|
| DiarrheaGastrointestinal disorders | 4/7 |
| Oral MucositisGastrointestinal disorders | 1/7 |
| FatigueGeneral disorders | 1/7 |
| AnemiaBlood and lymphatic system disorders | 1/7 |
| AnorexiaMetabolism and nutrition disorders | 1/7 |
| DysphagiaGastrointestinal disorders | 1/7 |
| Age, Continuous(Years) | Treatment With Abemaciclib |
|---|---|
| Mean | 64 ± 10 |
| Sex: Female, Male(Participants) | Treatment With Abemaciclib |
|---|---|
| Female | 2 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Treatment With Abemaciclib |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment With Abemaciclib |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Primary site(Participants) | Treatment With Abemaciclib |
|---|---|
| Oral Cavity | 7 |
| Hypopharynx | 0 |
| larynx | 0 |
| p16 negative oropharynx | 0 |
| p16 Status(Participants) | Treatment With Abemaciclib |
|---|---|
| p16 negative | 6 |
| Unknown | 1 |
| Baseline Tumor Size(cm) | Treatment With Abemaciclib |
|---|---|
| Mean | 3.5 ± 1.6 |
| Smoked >100 cigarettes in lifetime(Participants) | Treatment With Abemaciclib |
|---|---|
| Count of participants | 5 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abemaciclib
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