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Head and Neck CancerPhase 2NCT03938337

Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer

A Phase 2 study testing Cohort 1 Not Previously Treated and Cohort 2 Treated Previously in people with Head and Neck Cancer, run by University of Alabama at Birmingham at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To assess the objective response rate of tumor lesions to abemaciclib in combination with pembrolizumab in patients with metastatic or recurrent squamous cell carcinoma of head and neck. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cohort 1 Not Previously Treated and Cohort 2 Treated Previously
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
8 Oct 2019to 3 Apr 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed (core biopsy proven) metastatic or recurrent squamous cell carcinoma of head and neck
  • Adequate pulmonary and cardiac function
  • Available archived tissue of primary tumor or resected tumor specimen with adequate samples
  • Prior treatment with immune checkpoint inhibitor is not allowed in cohort 1 patients. Patients in cohort 2 should have failed or progressed on prior immune checkpoint inhibitor
  • Eastern Cooperative Oncology Group Performance Status(ECOG PS) = 0 or 1
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse [CTCAE] Grade <= 1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at lease 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy)
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  • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization
  • The patient is able to swallow oral medications
  • Adequate hematologic and end-organ function
  • Absolute Neutrophil Count (ANC) >= 1500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin (Hb) ≥ 8g/dl (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion)
  • Creatinine (Cr) ≤ 1.5 x Upper Limit of Normal (ULN) or Creatinine Clearance (CrCl) ≥ 60 ml/min
  • Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert syndrome, who can have total Bilirubin < 2.0 x ULN and direct bilirubin within normal limits are permitted.)
  • Aspartate Aminotransferase (AST) and Alanine aminotransferase (ALT) and alkaline phosphatase ≤ ULN
  • Agreement to remain abstinent or use appropriate contraception, among women of childbearing potential
  • Willingness and ability to consent for self to participate in study
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

  • Autoimmune disease (Note: Vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, and conditions not expected to recur in the absence of an external trigger are permitted.)
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to study treatment (Note: Inhaled and topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.)
  • Preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Immunosuppression, of any kind
  • Prior treatment with Cyclin-Dependent Kinase(CDK) 4/6 Inhibitor
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment, and must have fully recovered from any such procedure
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  • Personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
  • Known active viral or non-viral hepatitis or cirrhosis
  • Any active infection requiring systemic treatment, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
  • History of gastrointestinal perforation or fistula in the 6 months prior to study treatment, unless underlying risk has been resolved (e.g., through surgical resection or repair)
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
  • Pregnancy or breastfeeding - Female patients must be surgically sterile (i.e., ≥6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) or be postmenopausal, or must agree to use effective contraception during the study and for 4 months following last dose of treatment. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to study treatment. Male patients must be surgically sterile or must agree to use effective contraception during the study and for 4 months following last dose of treatment.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Clinical Trial of Abemaciclib in Combination With Pembrolizumab in Patients With Metastatic or Recurrent Head and Neck Cancer

To assess the objective response rate of tumor lesions to abemaciclib in combination with pembrolizumab in patients with metastatic or recurrent squamous cell carcinoma of head and neck.

Read the detailed description

Immunotherapy has been recently approved for patients with metastatic or recurrent squamous cell carcinoma of the head and neck. However, only a small percentage of patients experience long-term control, necessitating new therapeutic strategies. Recently, it was shown preclinically and in breast tumors that abemaciclib stimulates production of type III interferons and hence enhances tumor antigen presentation. Abemaciclib also suppressed the proliferation of regulatory T cells. These events promote cytotoxic T-cell-mediated clearance of tumor cells, which is further enhanced by the addition of immune checkpoint blockade. Based on these data, a phase II trial in patients with metastatic or recurrent head and neck cancer who are eligible for immunotherapy is proposed to investigate the combination of abemaciclib with pembrolizumab. Tumor \& blood analysis for interferon gamma signature will be explored as possible biomarkers.

Being tested
Cohort 1 Not Previously Treated, Cohort 2 Treated Previously
Keywords
immunotherapy, abemaciclib, pembrolizumab, Cyclin-Dependent Kinase (CDK): CDK4, Cyclin-Dependent Kinase (CDK): CDK6
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort 1 Not Previously TreatedDrug

    Also called CDK4:CDK6

    Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

  • Cohort 2 Treated PreviouslyDrug

    Also called CDK4:CDK6

    Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

Study groups in NCT03938337
Study groupRoleWhat they receive
Cohort 1 Not Previously TreatedExperimentalPatients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.
Receives: Drug: Cohort 1 Not Previously Treated
Cohort 2 Treated PreviouslyExperimentalPatients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.
Receives: Drug: Cohort 2 Treated Previously

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Assess the Objective Response Rate of Tumor Lesions Using Scans

    Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans

    Measured: Baseline

  2. To Assess the Objective Response Rate of Tumor Lesions Using Scans

    Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans

    Measured: Baseline to 5 months

  3. To Assess the Objective Response Rate of Tumor Lesions Using Scans

    Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans

    Measured: Baseline to 8 months

Secondary outcomes (11)

  1. Number of Participants Experiencing Adverse Events Grade 3 or Greater

    Measure adverse events grade 3 or greater to evaluate safety and tolerability

    Measured: Baseline to 1 month

  2. Number of Participants Experiencing Adverse Events Grade 3 or Greater

    Measure adverse events grade 3 or greater to evaluate safety and tolerability

    Measured: Baseline to 6 months

  3. Number of Participants Experiencing Adverse Events Grade 3 or Greater

    Measure adverse events grade 3 or greater to evaluate safety and tolerability

    Measured: Baseline to 12 months

  4. To Assess Progression Free Survival (PFS)

    Using scan results to assess whether tumor has progressed and the time;

    Measured: baseline to 6 months

  5. To Assess Progression Free Survival (PFS)

    Using scan results to assess whether tumor has progressed and the time;

    Measured: baseline to 12 months

  6. To Assess Overall Survival

    time that the patient is experiencing survival

    Measured: baseline to 6 months

  7. To Assess Overall Survival

    time that the patient is experiencing survival

    Measured: baseline to 12 months

  8. To Assess the Time to Tumor Response

    using scan results to assess the time it takes for the tumor to respond to treatment

    Measured: baseline to 6 months

  9. To Assess the Time to Tumor Response

    using scan results to assess the time it takes for the tumor to respond to treatment

    Measured: baseline to 12 months

  10. To Assess the Duration of Response

    using scan results to measure the total amount of time that the tumor is responding to treatment

    Measured: baseline to 6 months

  11. To Assess the Duration of Response

    using scan results to measure the total amount of time that the tumor is responding to treatment

    Measured: baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start8 Oct 2019
  3. Primary completion3 Apr 2020
  4. Study completion3 Apr 2020

Why it stopped: Sponsor terminated study due to higher incidence of pulmonary toxicity than expected, including death

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03938337
Sponsor's protocol ID
UAB 1891
Status last verified
Jun 2021
First submitted
2 May 2019
Last updated
9 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: To Be Determined

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cohort 1 Not Previously Treated and Cohort 2 Treated Previously in people with Head and Neck Cancer, run by University of Alabama at Birmingham at 1 site 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 18 inclusion and 14 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 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 9 Jul 2021). 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?

To Assess the Objective Response Rate of Tumor Lesions Using Scans (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03938337.

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 9 Jul 2021.

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