Abemaciclib for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Arizona
Must not be taking: CDK 4/6 inhibitors, PD-1/L1 inhibitors
Disqualifiers: Autoimmune disorders, Cardiac abnormalities, Active infections, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this 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).
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, if you are on drugs that strongly affect liver enzymes (CYP3A), you may need to stop them at least 7 days before starting the trial, unless a suitable substitute is found.
How does the drug Abemaciclib differ from other treatments for head and neck cancer?
Abemaciclib is unique because it is a CDK4/6 inhibitor, which means it works by blocking proteins that promote cancer cell growth. This mechanism is different from other treatments like chemotherapy or immune checkpoint inhibitors, which target cancer cells or the immune system in other ways.
12345Eligibility Criteria
This trial is for adults with HPV-negative head and neck squamous cell carcinoma (HNSCC) who have not been treated before. They must be physically well enough to participate, able to swallow pills, and have no serious heart or lung conditions. Patients with certain previous cancers can join if they've been cancer-free for 2 years. Women of childbearing potential must use effective contraception.Inclusion Criteria
My cancer can be measured by scans or physical tools.
I have not received any treatment for my head and neck cancer.
You agree to provide tissue samples for research purposes, including a biopsy of the tumor before and during surgery.
+25 more
Exclusion Criteria
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
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. 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
I have not taken any CDK 4/6 or PD-1/L1 inhibitors.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive neoadjuvant abemaciclib for 10-21 days, with a possible extension up to 28 days due to surgical delays
10-28 days
Daily administration
Surgery
Participants undergo planned oncologic surgery after the treatment phase
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including biomarker analysis and tumor size assessment
8 weeks
Participant Groups
The AIM Trial is testing the effects of a drug called Abemaciclib in patients with specific types of HNSCC that are HPV-negative. It's an open label Phase II trial where all participants receive the drug before their planned surgery to remove the tumor.
1Treatment groups
Experimental Treatment
Group I: Treatment with abemaciclibExperimental Treatment1 Intervention
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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ArizonaTucson, AZ
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Who Is Running the Clinical Trial?
University of ArizonaLead Sponsor
George Washington UniversityCollaborator
References
A phase I study afatinib/carboplatin/paclitaxel induction chemotherapy followed by standard chemoradiation in HPV-negative or high-risk HPV-positive locally advanced stage III/IVa/IVb head and neck squamous cell carcinoma. [2018]Afatinib is an ErbB family receptor inhibitor with efficacy in head and neck squamous cell carcinoma (HNSCC). A phase I trial was conducted to determine the maximally tolerated dose (MTD) of afatinib in combination with carboplatin and paclitaxel as induction chemotherapy (IC).
JAVELIN Head and Neck 100: a Phase III trial of avelumab and chemoradiation for locally advanced head and neck cancer. [2020]Chemoradiotherapy (CRT) is the standard of care for locoregionally advanced squamous cell carcinomas of the head and neck (HNSCC). The immune checkpoint inhibitors nivolumab and pembrolizumab were recently approved by the US FDA for treatment of recurrent or metastatic HNSCC that are refractory to platinum chemotherapy. However, prospective studies incorporating immune checkpoint inhibitors in the definitive management of poor prognosis, nonmetastatic, locoregionally advanced HNSCC are lacking. The JAVELIN Head and Neck 100 study is a multinational, Phase III, double-blind, placebo-controlled, randomized clinical trial assessing the efficacy of avelumab, a PD-L1 inhibitor, in combination with CRT compared with placebo in combination with CRT for high-risk HNSCC. Trial registration: Javelin Head and Neck 100; NCT 02952586.
Durvalumab for recurrent or metastatic head and neck squamous cell carcinoma: Results from a single-arm, phase II study in patients with ≥25% tumour cell PD-L1 expression who have progressed on platinum-based chemotherapy. [2020]Patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) progressing on platinum-based chemotherapy have poor prognoses and limited therapeutic options. Programmed cell death-1 (PD-1) and its ligand 1 (PD-L1) are frequently upregulated in HNSCC. The international, multi-institutional, single-arm, phase II HAWK study (NCT02207530) evaluated durvalumab monotherapy, an anti-PD-L1 monoclonal antibody, in PD-L1-high patients with platinum-refractory R/M HNSCC.
Phase II Window Study of Olaparib Alone or with Cisplatin or Durvalumab in Operable Head and Neck Cancer. [2023]We conducted a phase II randomized noncomparative window of opportunity (WOO) trial to evaluate the inhibition of cellular proliferation and the modulation of immune microenvironment after treatment with olaparib alone or in combination with cisplatin or durvalumab in patients with operable head and neck squamous cell carcinoma (HNSCC).
Successful Treatment of Refractory Squamous Cell Cancer of the Head and Neck with Nivolumab and Ipilimumab. [2022]Treatment options for patients with platinum-refractory, recurrent, metastatic head and neck squamous cell carcinoma (HNSCC) are limited, and prognosis is poor. Nivolumab (Opdivo) has been approved by the US Food and Drug Administration (FDA) for the treatment of patients with recurrent or metastatic HNSCC who have disease progression on or after platinum-based therapy. Recently, in patients with metastatic malignant melanoma a significant improvement of outcome and response was achieved with the combination of ipilimumab (CTLA4 antibody) and the programmed death (PD)-1 inhibitor nivolumab compared with monotherapy. Based on these results, the combination of nivolumab and ipilimumab has been approved by the FDA for the treatment of patients with unresectable or metastatic melanoma. So far, there have been no data concerning the combination of nivolumab and ipilimumab in squamous cell head and neck cancer. We here present the case of a 46-year-old male with refractory squamous cell head and neck cancer, who was successfully treated with the PD-1 inhibitor nivolumab in combination with the anti-CTLA4 antibody ipilimumab.