Neoplasms

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Carcinoma, Merkel Cell

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Merkel Cell Carcinoma

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Mitoguazone

Antineoplastic Agents, Immunological

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Immunologic Factors

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.

Biopsy

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Retifanlimab

Tuparstobart

Verzistobart

Shailender Bhatia, MD

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.

OUTLINE:

All patients receive the same investigational drug combination.

SCREENING: Patients undergo history and physical examination, adverse event assessment, safety and eligibility labs, radiologic evaluation with computed tomography (CT)/magnetic resonance imaging (MRI), and complete informed consent.

INDUCTION PHASE: Patients receive anti-LAG-3 and anti-TIM-3 intravenously (IV) every 2 weeks along with retifanlimab (anti-PD-1) IV every 4 weeks, along with clinical visit, physical examination, and labs for safety. Treatment continues for up to day 169 in the absence of disease progression or unacceptable toxicity. Patients undergo CT/MRI every 8 weeks. Research tumor biopsies will be obtained on day 1 and day 15 unless unsafe and unfeasible. Research blood draws will occur at day 1, day 15, and periodically throughout Induction Phase.

MAINTENANCE PHASE: Patients receive all three drugs IV every 6 weeks along with clinical visit, physical examination, and labs for safety. Treatment continues for up to day 715 in the absence of disease progression or unacceptable toxicity. Patients undergo CT/MRI every 12 weeks. Research blood sample collection will continue periodically.

Patients with progressive disease per investigator evaluation will stop receiving therapy. Research blood and tumor biopsies will be obtained at time of progression if safe and feasible.

Upon completion of study treatment (day 715 or sooner for disease progression), safety visits occur at 30 and 90 days. Follow up for long term outcomes continues every 6 months for up to 5 years.

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

A Proof-of-Concept Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma

Defined as the proportion of participants having a best objective response of complete response (CR) or partial response (PR), as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.

The Kaplan-Meier technique will be used to obtain estimates.

Defined as the proportion of participants having CR, PR, or stable disease as their best objective response to the study treatment, per RECIST v1.1.

Cumulative incidence estimates will be used to summarize the probabilities.

Including the frequency and duration of immune-related adverse events, rates of treatment interruption and treatment discontinuation, and the use of immunosuppressive medications for toxicities. Measured by Common Terminology Criteria for Adverse Events.

Incyte Corporation

University of Washington

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma	NCT06056895	Unresectable Cl... Clinical Stage ... Merkel Cell Car...	Biopsy Biospecimen Col... Computed Tomogr... Magnetic Resona... Retifanlimab Tuparstobart Verzistobart	18 Years -	University of Washington
Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma	NCT06056895	Unresectable Cl... Clinical Stage ... Merkel Cell Car...	Biopsy Biospecimen Col... Computed Tomogr... Magnetic Resona... Retifanlimab Tuparstobart Verzistobart	18 Years -	University of Washington

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