Description:
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.
Title
- Brief Title: Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Official Title: A Phase I Study of Avelumab, Palbociclib, and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
171386
- NCT ID:
NCT03498378
Conditions
- Head and Neck Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Avelumab | Bavencio | Avelumab, Palbociclib, and Cetuximab |
Palbociclib | IBRANCE | Avelumab, Palbociclib, and Cetuximab |
Cetuximab | ERBITUX | Avelumab, Palbociclib, and Cetuximab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Avelumab, Palbociclib, and Cetuximab | Experimental | Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab | - Avelumab
- Palbociclib
- Cetuximab
|
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | maximum tolerated dose |
Time Frame: | 12 months |
Safety Issue: | |
Description: | maximum tolerated dose/recommended phase II dose. |
Secondary Outcome Measures
Measure: | Overall response rate |
Time Frame: | through study completion, an average of 3 years |
Safety Issue: | |
Description: | Determined by RECIST 1.1 |
Measure: | progression free survival |
Time Frame: | through study completion, an average of 3 years |
Safety Issue: | |
Description: | |
Measure: | overall survival |
Time Frame: | through study completion, an average of 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
Time Frame: | through study completion, an average of 3 years |
Safety Issue: | |
Description: | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Kathryn Gold |
Trial Keywords
- Avelumab
- Palbociclib
- Cetuximab
- Head and Neck Squamous Cell Carcinoma
- cancer
- Recurrent Head and Neck Squamous Cell Carcinoma
- Metastatic Head and Neck Squamous Cell Carcinoma
Last Updated
October 19, 2020