Trial · NCT03850691
Radiation and Combination Immunotherapy for Melanoma
NCT03850691, Phase 2, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2023-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation and Combination Immunotherapy for Melanoma. Trials, record NCT03850691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03850691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation and Combination Immunotherapy for Melanoma
- NCT number
- NCT03850691
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Metastatic Melanoma
- Interventions
- Aldesleukin: All Patients, Nivolumab: Cohort 1 (Cutaneous), Nivolumab: Cohort 2 (Ocular), Ipilimumab: Cohort 2 (Ocular)
- First posted
- 2019-02-22
- Last updated
- 2024-01-17
- Results first posted
- 2023-03-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | up to approximately 2 Years | Determine the objective response rate (ORR). The ORR will be presented as the proportion of patients who achieved complete response (CR) or partial response (PR). In general, categorical data measurements will be summarized as counts and percentages (or proportions). The disease control rate (DCR) will be presented as the proportion of patients with CR, PR, or stable disease. The best overall response (BOR) will be measured as the maximum change from baseline in the sum of the longest diameter for each of the target lesions over the full 2 year follow-up period. |
| Primary | Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events) | Approximately up to 2 Years | This will be achieved by the number of adverse event (AE) reports. AEs, SAEs, deaths, and abnormal laboratory values will be summarized by the proportion of patients who experience them. Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All on-study AEs, Grade 3-4 AEs, treatment-related AEs, Grade 3-4 treatment-related AEs, SAEs, treatment-related SAEs, and AEs leading to discontinuation will be tabulated using the worst grade per NCI CTCAE v 5.0 criteria by system organ class. |
| Primary | Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events) | Approximately up to 2 Years | This will be measured by the number of participants who are suspended from the trial as noted by a stopping rule event. These events are determined after serious adverse events are graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The following events count toward an early stopping rule event: 1) Any Grade 2 or greater drug-related uveitis, eye pain, or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within 7 days of checkpoint inhibitor OR requires systemic treatment with corticosteroids, 2) Any Grade 3 or greater non-skin, drug-related adverse event lasting \> 7 days, including uveitis, pneumonitis, bronchospasm, diarrhea, colitis, neurologic toxicity, hypersensitivity reactions, and infusion reactions. In addition, the trial would be stopped and re-evaluated if there is ≥ 1 treatment-related mortality event. |
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 | Objective Response Rate (ORR) | up to approximately 2 Years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events) | Approximately up to 2 Years | Adverse events | NUMBER | |
| PRIMARY | Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events) | Approximately up to 2 Years | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Cohort 1: Nivolumab | 1 | Participants | ||
| Objective Response Rate (ORR) | Cohort 2: Nivolumab & Ipilimumab | 1 | Participants | ||
| Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events) | Cohort 1: Nivolumab | 3 | Adverse events | ||
| Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events) | Cohort 2: Nivolumab & Ipilimumab | 0 | Adverse events | ||
| Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events) | Cohort 1: Nivolumab | 0 | Participants | ||
| Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events) | Cohort 2: Nivolumab & Ipilimumab | 0 | Participants |
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 | Cohort 1: Nivolumab | 1 | |
| Overall Study | STARTED | Cohort 2: Nivolumab & Ipilimumab | 3 | |
| Overall Study | COMPLETED | Cohort 1: Nivolumab | 1 | |
| Overall Study | COMPLETED | Cohort 2: Nivolumab & Ipilimumab | 3 | |
| Overall Study | NOT COMPLETED | Cohort 1: Nivolumab | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2: Nivolumab & Ipilimumab | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Lymphocyte count decreased | Investigations | Cohort 1: Nivolumab | 1 | 1 | 1 |
| other | Lymphocyte count decreased | Investigations | Cohort 2: Nivolumab & Ipilimumab | 0 | 3 | |
| other | Infections and infestations - Other, specify | Investigations | Cohort 1: Nivolumab | 1 | 1 | 1 |
| other | Infections and infestations - Other, specify | Investigations | Cohort 2: Nivolumab & Ipilimumab | 0 | 3 | |
| other | Investigations - Other, specify | Investigations | Cohort 1: Nivolumab | 1 | 1 | 1 |
| other | Investigations - Other, specify | Investigations | Cohort 2: Nivolumab & Ipilimumab | 0 | 3 | |
| serious | Pruritus | Skin and subcutaneous tissue disorders | Cohort 1: Nivolumab | 0 | 1 | 0 |
| serious | Pruritus | Skin and subcutaneous tissue disorders | Cohort 2: Nivolumab & Ipilimumab | 0 | 3 | 0 |
| serious | Other | Metabolism and nutrition disorders | Cohort 1: Nivolumab | 1 | 1 | 1 |
| serious | Other | Metabolism and nutrition disorders | Cohort 2: Nivolumab & Ipilimumab | 0 | 3 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Nivolumab | 1 | 1 |
| Total, all-cause mortality | Cohort 2: Nivolumab & Ipilimumab | 2 | 3 |
| Total, other adverse events | Cohort 1: Nivolumab | 1 | 1 |
| Total, other adverse events | Cohort 2: Nivolumab & Ipilimumab | 0 | 3 |
| Total, serious adverse events | Cohort 1: Nivolumab | 1 | 1 |
| Total, serious adverse events | Cohort 2: Nivolumab & Ipilimumab | 0 | 3 |
Source ClinicalTrials.gov
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Nivolumab vs Cohort 2: Nivolumab & Ipilimumab: Objective Response Rate (ORR) | Trial comparisons |
| Cohort 1: Nivolumab vs Cohort 2: Nivolumab & Ipilimumab: Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events) | Trial comparisons |
| Cohort 1: Nivolumab vs Cohort 2: Nivolumab & Ipilimumab: deaths from any cause | Trial comparisons |
| Cohort 1: Nivolumab vs Cohort 2: Nivolumab & Ipilimumab: 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/NCT03850691
GET https://conductscience.org/api/trials/v1/NCT03850691/registered