- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03938337
Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer
16. června 2021 aktualizováno: Eddy Yang, University of Alabama at Birmingham
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.
Přehled studie
Postavení
Ukončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
1
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama at Birmingham
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- 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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Cohort 1 Not Previously Treated
Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.
|
Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
Ostatní jména:
|
Experimentální: Cohort 2 Treated Previously
Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.
|
Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
To Assess the Objective Response Rate of Tumor Lesions Using Scans
Časové okno: Baseline
|
Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans
|
Baseline
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To Assess the Objective Response Rate of Tumor Lesions Using Scans
Časové okno: Baseline to 5 months
|
Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans
|
Baseline to 5 months
|
To Assess the Objective Response Rate of Tumor Lesions Using Scans
Časové okno: Baseline to 8 months
|
Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans
|
Baseline to 8 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of Participants Experiencing Adverse Events Grade 3 or Greater
Časové okno: Baseline to 1 month
|
Measure adverse events grade 3 or greater to evaluate safety and tolerability
|
Baseline to 1 month
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Number of Participants Experiencing Adverse Events Grade 3 or Greater
Časové okno: Baseline to 6 months
|
Measure adverse events grade 3 or greater to evaluate safety and tolerability
|
Baseline to 6 months
|
Number of Participants Experiencing Adverse Events Grade 3 or Greater
Časové okno: Baseline to 12 months
|
Measure adverse events grade 3 or greater to evaluate safety and tolerability
|
Baseline to 12 months
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To Assess Progression Free Survival (PFS)
Časové okno: baseline to 6 months
|
Using scan results to assess whether tumor has progressed and the time;
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baseline to 6 months
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To Assess Progression Free Survival (PFS)
Časové okno: baseline to 12 months
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Using scan results to assess whether tumor has progressed and the time;
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baseline to 12 months
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To Assess Overall Survival
Časové okno: baseline to 6 months
|
time that the patient is experiencing survival
|
baseline to 6 months
|
To Assess Overall Survival
Časové okno: baseline to 12 months
|
time that the patient is experiencing survival
|
baseline to 12 months
|
To Assess the Time to Tumor Response
Časové okno: baseline to 6 months
|
using scan results to assess the time it takes for the tumor to respond to treatment
|
baseline to 6 months
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To Assess the Time to Tumor Response
Časové okno: baseline to 12 months
|
using scan results to assess the time it takes for the tumor to respond to treatment
|
baseline to 12 months
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To Assess the Duration of Response
Časové okno: baseline to 6 months
|
using scan results to measure the total amount of time that the tumor is responding to treatment
|
baseline to 6 months
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To Assess the Duration of Response
Časové okno: baseline to 12 months
|
using scan results to measure the total amount of time that the tumor is responding to treatment
|
baseline to 12 months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Eddy Yang, MD, University of Alabama at Birmingham
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
8. října 2019
Primární dokončení (Aktuální)
3. dubna 2020
Dokončení studie (Aktuální)
3. dubna 2020
Termíny zápisu do studia
První předloženo
2. května 2019
První předloženo, které splnilo kritéria kontroly kvality
3. května 2019
První zveřejněno (Aktuální)
6. května 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. července 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. června 2021
Naposledy ověřeno
1. června 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UAB 1891
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
To Be Determined
Časový rámec sdílení IPD
As long as study record is posted on CT.gov
Kritéria přístupu pro sdílení IPD
To Be Determined
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ano
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .