Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT03498378
- Lead Sponsor
- Kathryn Gold
- Brief Summary
The purpose of the study is to find out if the study drugs Avelumab, Cetuximab, and Palbociclib will slow or stop your cancer from getting worse, and whether it causes side effects. The second purpose is to measure whether your cancer responds to the study drugs Avelumab, Cetuximab, and Palbociclib. The study drugs Avelumab, Cetuximab, and Palbociclib are types of drugs called a monoclonal antibody. Monoclonal antibodies are made to recognize, target, and bind to specific proteins on cells the building blocks making up your tissues.
- Detailed Description
This is an open-label phase I trial with a 3+3 dose escalation design. All patients will receive avelumab, cetuximab, and palbociclib. This study will enroll patients with head and neck squamous cell carcinoma not amenable to curative intent therapy.
Treatment will be administered in 28 day cycles with a pre-defined dose escalation schedule.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
- Presence of measurable tumor lesions per RECIST criteria v1.1
- Life expectancy greater than 12 weeks.
- Adequate hematologic, hepatic, and renal function
- Negative serum or urine pregnancy test for women of child bearing potential
- Prior therapy with an EGFR inhibitor or PD-1 or PD-L1 inhibitor in the recurrent or metastatic setting
- Uncontrolled central nervous system metastases (stable metastases permitted)
- Chemotherapy 28 days prior to first administration of study treatment and/or monoclonal antibody ≤8 weeks prior to first administration of study treatment.
- History of other malignancies,
- Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of >10 mg/day of prednisone or equivalent)
- Prior organ transplantation
- Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Avelumab, Palbociclib, and Cetuximab Palbociclib Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab Avelumab, Palbociclib, and Cetuximab Avelumab Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab Avelumab, Palbociclib, and Cetuximab Cetuximab Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab
- Primary Outcome Measures
Name Time Method maximum tolerated dose 12 months maximum tolerated dose/recommended phase II dose.
- Secondary Outcome Measures
Name Time Method Overall response rate through study completion, an average of 3 years Determined by RECIST 1.1
progression free survival through study completion, an average of 3 years progression free survival
overall survival through study completion, an average of 3 years overall survival
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] through study completion, an average of 3 years Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Trial Locations
- Locations (1)
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States