Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

Conditions

• Other Skin

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR — BIOLOGICAL
  Given IV
• Avelumab — DRUG
  Given IV
• Pembrolizumab — BIOLOGICAL
  Given IV
• Interferon Gamma-1b — BIOLOGICAL
  Given SC

Study Details

This phase I/II trial studies the side effects of gene-modified immune cells (FH-MCVA2TCR) and to see how well they work in treating patients with Merkel cell cancer that has spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable). Placing a gene that has been created in the laboratory into immune cells may improve the body's ability to fight Merkel cell cancer.

Key Dates

Start date

Jul 3, 2019

Status verified

Mar 2025

Primary completion

Jan 9, 2024

Completion

Jan 9, 2024

Study Design

Enrollment

7 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Treatment (TCR-T cells, avelumab or pembrolizumab)
  Approximated 5-7 days prior to receiving FH-MCVA2TCR T-cells, patients receive interferon gamma administered at the FDA-approved dosing of 50mcg/m2, 3 times weekly for a total of 4 weeks. Patients receive FH-MCVA2TCR T-cells IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells.
• Experimental: Treatment 2 (TCR-T cells, avelumab or pembrolizumab)
  Approximated 5-7 days prior to receiving FH-MCVA2TCR T-cells, patients receive interferon gamma administered at the FDA-approved dosing of 50mcg/m2, 3 times weekly for a total of 4 weeks. Patients receive FH-MCVA2TCR T-cells IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells.

Primary Outcome Measure

Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments. [ Time Frame: Up to 1 year post infusion ]

Locations (1)

Related coverage on Hipa.ai

• Pembrolizumab in Merkel Cell Cancer Trial Shows No Overall Response
  Pembrolizumab · Mar 6, 2025 · ClinicalTrials.gov

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