Trial results for gene-modified immune cells (FH-MCVA2TCR) in combination with other agents, including pembrolizumab, for metastatic or unresectable Merkel cell cancer were posted on ClinicalTrials.gov on 2025-03-06. The terminated Phase 1/2 trial reported 0 participants achieving a best overall response across all treatment cohorts.
Background
Merkel cell cancer is a rare and aggressive form of skin cancer, challenging to treat when metastatic or unresectable. This trial investigated a novel approach using gene-modified immune cells (FH-MCVA2TCR) designed to target the cancer, in various combinations with other therapies. The study aimed to explore the potential of these modified cells to improve the body's ability to fight Merkel cell cancer.
Trial design
This terminated Phase 1/2 trial (NCT03747484) enrolled 7 participants with metastatic or unresectable Merkel cell cancer. The study evaluated the side effects and efficacy of gene-modified immune cells (FH-MCVA2TCR) administered in different cohorts. Interventions included avelumab, pembrolizumab, and interferon gamma-1b. The trial explored various regimens, including combinations with radiation, cyclophosphamide/fludarabine (Cy/Flu), and interferon gamma.
Key results
The trial reported on the incidence of Grade 3 or higher adverse events and best overall response across the different treatment cohorts:
- For "Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments":
- Cohort 1 (Radiation + One Infusion at DL1): 0 Participants
- Cohort 2 (Radiation + One Infusion at DL2): 0 Participants
- Cohort 3 (Radiation + One Infusion at DL1 + One Infusion at DL2): 1 Participants
- Cohort 4 (Cy/Flu + One Infusion at DL1 + One Infusion at DL2): 2 Participants
- Cohort 5 (Interferon Gamma + One Infusion at DL1): 0 Participants
- For "Best Overall Response":
- Cohort 1 (Radiation + One Infusion at DL1): 0 participants
- Cohort 2 (Radiation + One Infusion at DL2): 0 participants
- Cohort 3 (Radiation + One Infusion at DL1 + One Infusion at DL2): 0 participants
- Cohort 4 (Cy/Flu + One Infusion at DL1 + One Infusion at DL2): 0 participants
- Cohort 5 (Interferon Gamma + One Infusion at DL1): 0 participants
What this means
The results from this small, terminated Phase 1/2 trial indicate that the investigational gene-modified immune cells (FH-MCVA2TCR), in combination with other agents including pembrolizumab, did not achieve an overall response in any of the 7 enrolled participants with metastatic or unresectable Merkel cell cancer. While most cohorts reported no Grade 3 or higher adverse events, Cohort 3 and Cohort 4 observed 1 and 2 participants, respectively, with such events. The trial's termination and lack of observed efficacy suggest this specific treatment approach did not meet its objectives.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov. The results for study NCT03747484, titled "Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer," were posted on 2025-03-06 on clinicaltrials.gov.