Neo-adjuvant Nivolumab or Nivolumab With Ipilimumab in Advanced Cutaneous Squamous Cell Carcinoma Prior to Surgery

Sponsor
The Netherlands Cancer Institute
Study ID
NCT04620200
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To determine the histopathological response rate to neo-adjuvant nivolumab and nivolumab plus ipilimumab at time of standard of care(surgery ± radiotherapy).in patients with cutaneous squamous cell carcinoma.

Key Dates

Start date
Aug 11, 2020
Status verified
Aug 2025
Primary completion
Jan 7, 2025
Completion
Jan 7, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM A
    2 courses of nivolumab 3 mg/kg in week 0 and 2 prior to standard of care
  • Experimental: ARM B
    2 courses of nivolumab 3 mg/kg in week 0 and 2 plus 1 course of ipilimumab 1mg/kg in week 0 prior to standard of care

Primary Outcome Measure

Histopathological response rate at standard of care [ Time Frame: At time of standard of care at week 4 ]

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