Trial · NCT04261855
Targeted Therapy and Avelumab in Merkel Cell Carcinoma
NCT04261855, Phase 1, Phase 2, Active not recruiting, Melanoma and Skin Cancer Trials Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeted Therapy and Avelumab in Merkel Cell Carcinoma. Trials, record NCT04261855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04261855
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted Therapy and Avelumab in Merkel Cell Carcinoma
- NCT number
- NCT04261855
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 19 participants, estimated
- Lead sponsor
- Melanoma and Skin Cancer Trials Limited
- Conditions
- Metastatic Merkel Cell Carcinoma
- Interventions
- Avelumab, External Beam Radiation Therapy (EBRT), Lutetium-177 (177Lu)-DOTATATE
- First posted
- 2020-02-10
- Last updated
- 2026-03-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) at 12 months | 3 years | To evaluate the anti-tumour activity as reflected by PFS rate at 12 months. PFS is defined as the time from treatment initiation until the first date of documented radiographic progression or death due to any cause, whichever occurs first. The radiographic progression will be assessed by the Investigator according to RECIST v1.1. |
| Secondary | Progression Free Survival (PFS) at 24 months | 4 years | Time to disease progression including rate at specific landmark timepoint of 24 months. |
| Secondary | Overall Survival (OS) at 12 and 24 months | 4 years | OS rates at specific landmark timepoints of 12 and 24 months. OS is defined as the time from treatment initiation to the date of death due to any cause. |
| Secondary | Best Objective Response Rate (ORR) according to RECIST v1.1 | 4 years | To evaluate best ORR according to response evaluation criteria in solid tumours version 1.1 (RECIST v1.1). ORR is defined as PR or CR at any stage from time of treatment initiation according to RECIST v1.1. |
| Secondary | The safety and tolerability of 177Lu-DOTATATE or EBRT in combination with avelumab. | 4 years | Rate of treatment-related adverse events (AEs). Safety will be measured by serious adverse events (SAEs) and AEs assessed using the NCI CTCAE v5.0. |
| Secondary | Rate of treatment discontinuation due to toxicity | 4 years | This is defined as the proportion of patients who discontinue with treatment due to treatment-related toxicity. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT04261855
GET https://conductscience.org/api/trials/v1/NCT04261855/registered