Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial) (NCT04169074) | Clinical Trial Compass
TerminatedPhase 2
Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial)
Stopped: Standard of care therapy for Stage III-IVA HNSCC updated in June to include neoadjuvant + adjuvant immunotherapy.
United States7 participantsStarted 2021-07-07
Plain-language 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).
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure Quantitative Change in Tumor Size to Assess the Clinical Activity of Abemaciclib.
Timeframe: This outcome measure will be assessed at baseline and post 10-21 (+7) days of neoadjuvant exposure to abemaciclib.
. 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:
Exclusion criteria
. 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:
. 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.