Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06056895
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Clinical Stage IV Merkel Cell Carcinoma AJCC v8
  • Merkel Cell Carcinoma
  • Unresectable Clinical Stage III Merkel Cell Carcinoma AJCC v8

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT/MRI
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo CT/MRI
  • Retifanlimab — BIOLOGICAL
    Given IV
  • Tuparstobart — DRUG
    Given IV
  • Verzistobart — DRUG
    Given IV

Study Details

This phase II trial tests how well a combination of three immunotherapy drugs work for patients with Merkel cell carcinoma that has spread to lymph nodes and/or distant parts of the body and cannot be treated with surgery (advanced or metastatic MCC) and grew despite prior PD-(L)1 therapy. The three drugs INCMGA00012 (retifanlimab, anti-PD-1), INCAGN02385 (tuparstobart, anti-LAG-3), and INCAGN02390 (verzistobart, anti-TIM-3) are monoclonal antibodies given periodically via IV to reactivate the body's immune system to attack the cancer. This combination may stop tumor growth if tumors have grown despite anti-PD-(L)1 therapy alone.

Key Dates

Start date
Nov 8, 2023
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (retifanlimab, tuparstobart, and verzistobart)
    INDUCTION PHASE: Patients receive retifanlimab IV over 30 minutes every 4 weeks and tuparstobart and verzistobart IV over 30 minutes every 2 weeks. Treatment continues for up to day 169 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography CT/MRI during screening and on study and blood sample collection on study and may undergo during screening. Patients may also undergo a tumor biopsy during screening and on study. MAINTENANCE PHASE: Patients receive retifanlimab, tuparstobart and verzistobart IV over 30 minutes every 6 weeks. Treatment continues for up to day 715 in the absence of disease progression or unacceptable toxicity. Patients undergo CT/MRI on study and blood sample collection on study and may undergo during follow-up. Patients may also undergo tumor biopsy on study and during follow-up.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 5 years following completion of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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