Trial · NCT03747484
Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer
NCT03747484, Phase 1, Phase 2, Terminated, Fred Hutchinson Cancer Center; results first posted 2025-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer. Trials, record NCT03747484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03747484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer
- NCT number
- NCT03747484
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Other Skin
- Interventions
- Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR, Avelumab, Pembrolizumab, Interferon Gamma-1b
- First posted
- 2018-11-20
- Last updated
- 2025-03-06
- Results first posted
- 2025-03-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments. | Up to 1 year post infusion | Assessed per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Evidence of excessive toxicity will be an observed proportion of toxicities for which the associated lower 80% confidence limit exceeds 40%. |
| Primary | Best Overall Response | Up to 1 year post infusion | Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of complete or partial response. Irradiated and non-irradiated lesions will be separately tracked but response determined in totality. |
| Secondary | Progression-free Survival | Up to 1 year post infusion | Will be estimated using the method of Kaplan and Meier, with time zero the time of first T cell infusion. |
| Secondary | Overall Survival | Up to 1 year post infusion | Will be estimated using the method of Kaplan and Meier, with time zero the time of first T cell infusion. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments. | Up to 1 year post infusion | Population included all enrolled and treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Best Overall Response | Up to 1 year post infusion | Population included all enrolled and treated participants. | participants | NUMBER |
| SECONDARY | Progression-free Survival | Up to 1 year post infusion | All enrolled and treated participants. | months | MEDIAN |
| SECONDARY | Overall Survival | Up to 1 year post infusion | Population included all enrolled and treated participants. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | ||
| Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments. | Cohort 2 - Radiation + One Infusion at DL2 | 0 | Participants | ||
| Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments. | Cohort 3 - Radiation + One Infusion at DL1 + One Infusion at DL2 | 1 | Participants | ||
| Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments. | Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 | 2 | Participants | ||
| Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments. | Cohort 5 - Interferon Gamma + One Infusion at DL1 | 0 | Participants | ||
| Best Overall Response | Cohort 1 - Radiation + One Infusion at DL1 | Complete Response (CR) | 0 | participants | |
| Best Overall Response | Cohort 2- Radiation + One Infusion at DL2 | Complete Response (CR) | 0 | participants | |
| Best Overall Response | Cohort 3 - Radiation + One Infusion at DL1 + One Infusion at DL2 | Complete Response (CR) | 0 | participants | |
| Best Overall Response | Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 | Complete Response (CR) | 0 | participants | |
| Best Overall Response | Cohort 5 - Interferon Gamma + One Infusion at DL1 | Complete Response (CR) | 0 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - Radiation + One Infusion at DL1 | 1 | |
| Overall Study | STARTED | Cohort 2 - Radiation + One Infusion at DL2 | 1 | |
| Overall Study | STARTED | Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 | 1 | |
| Overall Study | STARTED | Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 | 2 | |
| Overall Study | STARTED | Cohort 5 - Interferon Gamma + One Infusion at DL1 | 2 | |
| Overall Study | COMPLETED | Cohort 1 - Radiation + One Infusion at DL1 | 1 | |
| Overall Study | COMPLETED | Cohort 2 - Radiation + One Infusion at DL2 | 0 | |
| Overall Study | COMPLETED | Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 | 0 | |
| Overall Study | COMPLETED | Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 | 0 | |
| Overall Study | COMPLETED | Cohort 5 - Interferon Gamma + One Infusion at DL1 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Altered Mental Status | Injury, poisoning and procedural complications | Cohort 1 - Radiation + One Infusion at DL1 | 0 | 1 | 0 |
| other | Altered Mental Status | Injury, poisoning and procedural complications | Cohort 2 - Radiation + One Infusion at DL2 | 0 | 1 | 0 |
| other | Altered Mental Status | Injury, poisoning and procedural complications | Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 | 1 | 1 | 1 |
| other | Altered Mental Status | Injury, poisoning and procedural complications | Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2 | 0 | 2 | 0 |
| other | Altered Mental Status | Injury, poisoning and procedural complications | Cohort 5 - Interferon Gamma + One Infusion at DL1 | 0 | 2 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1 - Radiation + One Infusion at DL1 | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2 - Radiation + One Infusion at DL2 | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2 | 1 | 2 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 5 - Interferon Gamma + One Infusion at DL1 | 0 | 2 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - Radiation + One Infusion at DL1 | 0 | 1 |
| Total, all-cause mortality | Cohort 2 - Radiation + One Infusion at DL2 | 0 | 1 |
| Total, all-cause mortality | Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 | 1 | 1 |
| Total, all-cause mortality | Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2 | 2 | 2 |
| Total, all-cause mortality | Cohort 5 - Interferon Gamma + One Infusion at DL1 | 0 | 2 |
| Total, other adverse events | Cohort 1 - Radiation + One Infusion at DL1 | 0 | 1 |
| Total, other adverse events | Cohort 2 - Radiation + One Infusion at DL2 | 0 | 1 |
| Total, other adverse events | Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 | 1 | 1 |
| Total, other adverse events | Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2 | 2 | 2 |
| Total, other adverse events | Cohort 5 - Interferon Gamma + One Infusion at DL1 | 2 | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42715345 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P01CA225517 | Immunobiology and Immune Therapy for Merkel Cell Carcinoma | NGHIEM, PAUL | UNIVERSITY OF WASHINGTON | NATIONAL CANCER INSTITUTE | 2019 to 2025 | NIH RePORTER |
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03747484
GET https://conductscience.org/api/trials/v1/NCT03747484/results?page=2