Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03498378|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2018
Last Update Posted : October 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Drug: Avelumab Drug: Palbociclib Drug: Cetuximab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Avelumab, Palbociclib, and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma|
|Actual Study Start Date :||June 6, 2018|
|Actual Primary Completion Date :||February 4, 2020|
|Estimated Study Completion Date :||January 2022|
Experimental: Avelumab, Palbociclib, and Cetuximab
Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab
Avelumab (IV on days 1 and 15 of 28 day cycle)
Other Name: Bavencio
Palbociclib (PO daily, days 1-21 of 28 day cycle)
Palbociclib will be administered in capsules of 125 mg, 100 mg, and 75 mg, depending on dosage. Patients will be instructed to take their assigned dose once daily with food for 21 days followed by 7 days off therapy. Patients will be encouraged to take their dose at approximately the same time each day.
Other Name: IBRANCE
Cetuximab (IV 400 mg/m2 x 1, then weekly)
Cetuximab is administered intravenously once weekly via infusion pump or syringe pump with infusion rate not to exceed 10 mg/min.
Other Name: ERBITUX
- maximum tolerated dose [ Time Frame: 12 months ]maximum tolerated dose/recommended phase II dose.
- Overall response rate [ Time Frame: through study completion, an average of 3 years ]Determined by RECIST 1.1
- progression free survival [ Time Frame: through study completion, an average of 3 years ]
- overall survival [ Time Frame: through study completion, an average of 3 years ]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: through study completion, an average of 3 years ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498378
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Kathryn A Gold, MD||University of California, San Diego|