| Protocol ID | NCT02659540 |
| Registration Date | 2016-01-20 |
| Status | completed |
| Sponsor | Ludwig Institute for Cancer Research |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2016-10-13 |
| Last Patient Out | 2020-07-27 |
| Publication | y |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT02659540
A Pilot (Phase 1) Study to Evaluate the Safety and Efficacy of Combination Checkpoint Blockade (Ipilimumab and Nivolumab) Plus External Beam Radiotherapy in Subjects With Stage IV Melanoma
| Field |
CLAUDE
claude-sonnet-4-20250514 5769ms / 13530 tok |
GLM
glm-5.1 8466ms / 11731 tok |
OPENAI
gpt-4o 3136ms / 11524 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This study involves outpatient cancer treatment with IV infusions and radiotherapy delivered at medical centers, which are typically outpatient oncology clinic settings rather than requiring hospital admission.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The study involves intravenous infusions of immunotherapy and external beam radiotherapy in an outpatient or clinical setting, as Stage IV melanoma patients with ECOG 0-1 are not required to be hospitalized for the intervention delivery.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The trial involves interventions such as radiotherapy and infusion of drugs which are administered based on institutional practices, potentially in outpatient clinics or mixed settings, not necessarily requiring hospital admission.
|
OK |
| feasibility |
feasibility RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — This is explicitly labeled as a 'pilot study' in the title with only 20 enrolled subjects and primary outcome focused on safety evaluation.
|
feasibility RCT
N/A → feasibility RCT
shaky reasoning✓ Unanimous
Initial: N/A
Requery: feasibility RCT — The trial is explicitly titled and described as a 'pilot study' with a small sample size of 20 participants, and its primary outcome is safety rather than powered clinical effectiveness.
|
feasibility RCT
N/A → feasibility RCT
shaky reasoning✓ Unanimous
Initial: N/A
Requery: feasibility RCT — The study explicitly states it is a pilot study with a primary objective to evaluate safety and only 18 subjects enrolled, indicating it is a feasibility study.
|
OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | yes | yes | yes | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | yes | yes | yes | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | immunotherapy | immunotherapy | immunotherapy | OK |