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Amivantamab and Hyaluronidase vs Cetuximab in Immunocompromised Cutaneous Squamous Cell Carcinoma
NCT07042295Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2026
- Primary completion
- Feb 2029
- Countries
- 1
- Sponsor
- National Cancer Institute
- Drugs
- amivantamab
- Conditions
- cutaneous squamous cell carcinoma (cSCC)
01
Overview
Phase 2, randomised, open-label trial of amivantamab in cutaneous squamous cell carcinoma (cSCC) (2 arms), sponsored by National Cancer Institute. Primary endpoints: Incidence of toxicity of interest at 4 weeks and Progression-Free Survival at 3 years. Started Mar 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm I (amivantamab and hyaluronidase)
Amivantamab and hyaluronidase SC on days 1, 8, 15, 22 of cycle 1 and day 1 of subsequent 28-day cycles.
Arm II (cetuximab)
Cetuximab IV on days 1 and 15 of each 28-day cycle.
03
Who it enrols
Adults with recurrent or metastatic cutaneous squamous cell carcinoma who are immunocompromised (e.g., due to hematologic malignancy, organ transplant, or autoimmune disease on immunosuppressants), with adequate organ function and no prior EGFR inhibitor treatment within the past year.
04
Endpoints
Primary
Incidence of toxicity of interest
Progression-Free Survival
Secondary
Organ rejection
Overall Survival
Progression-Free Survival
Time to next treatment
Time to progression
Duration of objective response
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