Trials / Terminated
TerminatedNCT03747484
Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer
ATTAC-MCC: Phase I/II Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity MCPyV-specific TCRs Combined With Avelumab and Class I MHC-upregulation in Patients With Metastatic MCC Refractory to PD-1 Axis Blockade
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OUTLINE: This is a dose escalation study of FH-MCVA2TCR autologous T-cells. Patients receive interferon gamma-1b subcutaneously (SC) on study. Patients receive FH-MCVA2TCR T-cells intravenously (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. After completion of study treatment, patients are followed up periodically for up to 15 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR | Given IV |
| DRUG | Avelumab | Given IV |
| BIOLOGICAL | Pembrolizumab | Given IV |
| BIOLOGICAL | Interferon Gamma-1b | Given SC |
Timeline
- Start date
- 2019-07-03
- Primary completion
- 2024-01-09
- Completion
- 2024-01-09
- First posted
- 2018-11-20
- Last updated
- 2025-03-06
- Results posted
- 2025-03-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03747484. Inclusion in this directory is not an endorsement.