Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor

Conditions

• HPV-unrelated Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Palbociclib — DRUG
  Administered on an outpatient basis
• Cetuximab — DRUG
  Given intravenously over approximately 60 minutes

Study Details

This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).

Key Dates

Start date

Apr 6, 2022

Status verified

May 2026

Primary completion

Feb 28, 2028

Completion

Feb 28, 2028

Study Design

Enrollment

81 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Palbociclib + Cetuximab
  * Palbociclib by mouth 125 mg/daily on Days 1-21 of each 28 day cycle * Cetuximab: Initial dose 400mg/m\^2 intravenous (IV); Subsequent doses 250 mg/m\^2 IV, weekly
• Active Comparator: Arm 2: Cetuximab
  -Cetuximab: Initial dose 400mg/m\^2 intravenous (IV); Subsequent doses 250 mg/m\^2 IV, weekly

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Through completion of follow-up (estimated to be 15 months) ]

Central Contacts

• Douglas Adkins, M.D.
  314-747-8475
  [email protected]

Locations (5)

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