Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, San Diego
Study ID
NCT06624475
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab is a fully humanized monoclonal antibody that binds to the Programmed Death-1 (PD-1) receptor, blocking its interactions with Programmed Death-Ligand 1 (PD-L1) and Programmed Death-Ligand 2 (PD-L2), and thus additionally inhibiting PD1-driven immune suppression. Nivolumab: 480 mg via intravenous administration (28 day cycle).
  • Relatlimab plus Nivolumab — DRUG
    Relatlimab plus Nivolumab (Opdualag) is supplied as a single dose vial containing 480 mg of Nivolumab and 160 mg Relatlimab for intravenous administration (28 day cycle).

Study Details

This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk basal cell carcinoma (HR BCC)

Key Dates

Start date
Aug 21, 2025
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Nivolumab 480 mg intravenous and Relatlimab 160 mg intravenous every 4 weeks, up to 4 cycles.
  • Experimental: Cohort 2
    Nivolumab 480 mg intravenous every 4 weeks, up to 4 cycles.

Primary Outcome Measure

Pathologic response rate [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92868
Mehir Tharani
[email protected]
877-827-8839
University of California, San Diego Moores Cancer CenterLa JollaCalifornia92093
Catherine O'Neil
[email protected]
858 822 5354
Soo Park, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94158
Sonia Contreras Martinez
[email protected]
(415) 714-4484
Adil Daud, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

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By specialty
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By research site
University of California, Irvine· Irvine, CAUniversity of California, San Diego Moores Cancer Center· La Jolla, CAUniversity of California, San Francisco· San Francisco, CA

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