Trial · NCT03071406
Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
NCT03071406, Phase 2, Active not recruiting, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2023-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma. Trials, record NCT03071406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03071406
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
- NCT number
- NCT03071406
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Merkel Cell Carcinoma, Skin Cancer
- Interventions
- Nivolumab, Ipilimumab, Stereotactic Body Radiation Therapy (SBRT)
- First posted
- 2017-03-06
- Last updated
- 2026-03-11
- Results first posted
- 2023-05-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response | Up to 18 months | Overall response according to Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) including Complete Response (CR) + Partial Response (PR). |
| Secondary | Progression Free Survival (PFS) | up to 28 months | Median Progression Free Survival with 95% Confidence Interval. Progression is defined as progressive tumor lesions per immune-related Response Evaluation in Solid Tumors (irRECIST) definition, or appearance of one or more new Merkel cell carcinoma lesions, which can be local or distant in location from the irradiated lesions. |
| Secondary | Overall Survival (OS) | Up to 30 months | Median Overall Survival with 95% Confidence Interval. The length of time from the start of treatment until death from any cause. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response | Up to 18 months | Evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | up to 28 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 30 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response | Arm A: Nivolumab + Ipilimumab | 18 | Participants | ||
| Best Overall Response | Arm B: Nivolumab + Ipilimumab + SBRT | 12 | Participants | ||
| Progression Free Survival (PFS) | Arm A: Nivolumab + Ipilimumab | 27.7 | 95% Confidence Interval 9.2 to NA | months | |
| Progression Free Survival (PFS) | Arm B: Nivolumab + Ipilimumab + SBRT | 7.6 | 95% Confidence Interval 2.8 to NA | months | |
| Overall Survival (OS) | Arm A: Nivolumab + Ipilimumab | 29.9 | 95% Confidence Interval 27.7 to NA | months | |
| Overall Survival (OS) | Arm B: Nivolumab + Ipilimumab + SBRT | 16 | 95% Confidence Interval 11.3 to NA | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Nivolumab + Ipilimumab | 25 | |
| Overall Study | STARTED | Arm B: Nivolumab + Ipilimumab + SBRT | 25 | |
| Overall Study | COMPLETED | Arm A: Nivolumab + Ipilimumab | 25 | |
| Overall Study | COMPLETED | Arm B: Nivolumab + Ipilimumab + SBRT | 24 | |
| Overall Study | NOT COMPLETED | Arm A: Nivolumab + Ipilimumab | 0 | |
| Overall Study | NOT COMPLETED | Arm B: Nivolumab + Ipilimumab + SBRT | 1 |
Source ClinicalTrials.gov
Adverse events518
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 | Fatigue | General disorders | Arm A: Nivolumab + Ipilimumab | 19 | 25 | 37 |
| other | Fatigue | General disorders | Arm B: Nivolumab + Ipilimumab + SBRT | 15 | 25 | 23 |
| other | Edema limbs | General disorders | Arm A: Nivolumab + Ipilimumab | 7 | 25 | 9 |
| other | Edema limbs | General disorders | Arm B: Nivolumab + Ipilimumab + SBRT | 9 | 25 | 11 |
| other | Pain | General disorders | Arm A: Nivolumab + Ipilimumab | 6 | 25 | 6 |
| other | Pain | General disorders | Arm B: Nivolumab + Ipilimumab + SBRT | 5 | 25 | 8 |
| other | General disorders and administration site conditions - Other | General disorders | Arm A: Nivolumab + Ipilimumab | 4 | 25 | 4 |
| other | General disorders and administration site conditions - Other | General disorders | Arm B: Nivolumab + Ipilimumab + SBRT | 2 | 25 | 4 |
| other | Fever | General disorders | Arm A: Nivolumab + Ipilimumab | 4 | 25 | 4 |
| other | Fever | General disorders | Arm B: Nivolumab + Ipilimumab + SBRT | 1 | 25 | 2 |
1 to 10 of 518Source ClinicalTrials.gov
See all 518 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Nivolumab + Ipilimumab | 11 | 25 |
| Total, all-cause mortality | Arm B: Nivolumab + Ipilimumab + SBRT | 15 | 25 |
| Total, other adverse events | Arm A: Nivolumab + Ipilimumab | 25 | 25 |
| Total, other adverse events | Arm B: Nivolumab + Ipilimumab + SBRT | 25 | 25 |
| Total, serious adverse events | Arm A: Nivolumab + Ipilimumab | 13 | 25 |
| Total, serious adverse events | Arm B: Nivolumab + Ipilimumab + SBRT | 13 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Nivolumab + Ipilimumab vs Arm B: Nivolumab + Ipilimumab + SBRT: Best Overall Response | Trial comparisons |
| Arm A: Nivolumab + Ipilimumab vs Arm B: Nivolumab + Ipilimumab + SBRT: deaths from any cause | Trial comparisons |
| Arm A: Nivolumab + Ipilimumab vs Arm B: Nivolumab + Ipilimumab + SBRT: serious adverse events | Trial comparisons |
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/NCT03071406
GET https://conductscience.org/api/trials/v1/NCT03071406/events?page=2