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

Extracted Fields (from Registry)
Protocol IDNCT02659540
Registration Date2016-01-20
Statuscompleted
SponsorLudwig Institute for Cancer Research
CountryUnited States
Industrynot industry
Blindingunblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2016-10-13
Last Patient Out2020-07-27
Publicationy
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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