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Updated: May 31, 2025

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Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma

Sandip P Patel1, Eleanor Cano-Linson2,3, Young Kwang Chae4

  • 1University of California at San Diego Moores Cancer Center, La Jolla, CA, USA. patel@ucsd.edu.

NPJ Precision Oncology
|January 24, 2025
PubMed

Insights

This study found that combining ipilimumab and nivolumab immunotherapy showed a 31% objective response rate in advanced basal cell cancer (BCC) patients. The treatment also demonstrated promising survival benefits and manageable toxicity in this rare cancer cohort.

Area of Science:

  • Oncology
  • Immunotherapy
  • Clinical Trials

Background:

  • Basal cell cancer (BCC) is a common skin cancer, but advanced or metastatic forms present significant treatment challenges.
  • Dual immune checkpoint blockade with anti-CTLA-4 and anti-PD-1 antibodies has shown efficacy in various cancers, but its role in BCC is less established.

Purpose of the Study:

  • To evaluate the efficacy and safety of combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) therapy in patients with advanced or metastatic basal cell cancer.
  • To determine the objective response rate (ORR) as the primary endpoint and assess overall survival (OS) and progression-free survival (PFS) as secondary endpoints.

Main Methods:

  • A phase II, prospective, multicenter basket trial (SWOG/NCI 1609 DART) enrolled patients with advanced/metastatic BCC.
  • Patients received a combination of nivolumab and ipilimumab.
  • Objective response rate (ORR) was assessed using RECIST v1.1 criteria.

Main Results:

  • The objective response rate (ORR) was 31% (95% CI, 19-50%) in 16 evaluable patients.
  • Twelve-month overall survival (OS) was 75% (95% CI, 57-100%).
  • Median progression-free survival (PFS) was 9.3 months (95% CI, 3.3-NA), with 66.7% of patients achieving clinical benefit (partial response or stable disease >6 months).
  • Common toxicities included fatigue (37.5%), pruritis (31.3%), and diarrhea (25%).

Conclusions:

  • Combination ipilimumab and nivolumab therapy demonstrates significant activity in advanced/metastatic basal cell cancer.
  • The regimen offers a potential new treatment option for BCC, with a notable ORR and prolonged PFS observed.
  • Further investigation is warranted to optimize immunotherapy strategies for rare tumor types like advanced BCC.

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