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 2021-06-16
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
SexALL
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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.
✓. 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:
What they're measuring
1
Measure quantitative change in tumor size to assess the clinical activity of abemaciclib.
✕. 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.