{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT02339571","title":"A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma","sponsor":"National Cancer Institute (NCI)","phases":["PHASE2","PHASE3"],"status":"ACTIVE_NOT_RECRUITING","indication":null,"disease":"skin carcinoma in situ"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"no","detail":"None of CTLA4, PDCD1, CSF2RA, CSF2RB has somatic-mutation evidence in skin carcinoma in situ","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: CTLA4 in skin carcinoma in situ","url":"https://platform.opentargets.org/evidence/ENSG00000163599/MONDO_0004641","date":"2026-11-11T22:02:57.854Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"no","detail":"No germline or somatic evidence for CTLA4, PDCD1, CSF2RA, CSF2RB in skin carcinoma in situ","rule":"Any germline or somatic human genetic evidence for the target in this cancer, counted apart from animal-model and literature evidence","source":{"label":"Open Targets: CTLA4 in skin carcinoma in situ","url":"https://platform.opentargets.org/evidence/ENSG00000163599/MONDO_0004641","date":"2026-11-11T22:02:57.854Z"},"context":[]},{"id":"pediatric_target","label":"Pediatric target","value":"yes","detail":"CTLA4, PDCD1 on the FDA list","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"no","detail":"Solid tumour","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571","date":"2026-11-11T22:02:57.854Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"CTLA4 (via Ipilimumab)","text":"Open Targets has no association between CTLA4 and skin carcinoma in situ.","source":{"label":"Open Targets: CTLA4 in skin carcinoma in situ","url":"https://platform.opentargets.org/evidence/ENSG00000163599/MONDO_0004641","date":"2026-11-11T22:02:57.854Z"}},{"label":"PDCD1 (via Nivolumab)","text":"Open Targets has no association between PDCD1 and skin carcinoma in situ.","source":{"label":"Open Targets: PDCD1 in skin carcinoma in situ","url":"https://platform.opentargets.org/evidence/ENSG00000188389/MONDO_0004641","date":"2026-11-11T22:02:57.854Z"}},{"label":"CSF2RA (via Sargramostim)","text":"Open Targets has no association between CSF2RA and skin carcinoma in situ.","source":{"label":"Open Targets: CSF2RA in skin carcinoma in situ","url":"https://platform.opentargets.org/evidence/ENSG00000198223/MONDO_0004641","date":"2026-11-11T22:02:57.854Z"}},{"label":"CSF2RB (via Sargramostim)","text":"Open Targets has no association between CSF2RB and skin carcinoma in situ.","source":{"label":"Open Targets: CSF2RB in skin carcinoma in situ","url":"https://platform.opentargets.org/evidence/ENSG00000100368/MONDO_0004641","date":"2026-11-11T22:02:57.854Z"}}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"yes","detail":"Randomised allocation","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571","date":"2026-11-11T22:02:57.854Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"no","detail":"600 planned; each patient moves a rate by 100 ÷ 600 = 0.2 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571","date":"2026-11-11T22:02:57.854Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"yes","detail":"Overall survival","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571","date":"2026-11-11T22:02:57.854Z"},"context":[]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2033-06-30; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571","date":"2026-11-11T22:02:57.854Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[{"label":"Stopped on this target","text":"179 terminated, withdrawn or suspended trials of drugs against CTLA4; 8 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"CTLA4: what already stopped","url":"/target/ENSG00000163599#stopped","date":"2026-11-11T22:02:57.884Z"}}],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"yes","detail":"All 763 sites in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571?tab=locations","date":"2026-11-11T22:02:57.854Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-002727-PIP03-23 (nivolumab;relatlimab, Treatment of melanoma): P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), 6 May 2024; EMA/PE/0000232765 (sargramostim, Treatment of pulmonary alveolar proteinosis): P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), 14 Apr 2025; EMA/PE/0000232936 (atigotatug;nivolumab, Treatment of small cell lung cancer): W: decision granting a waiver in all age groups for all conditions or indications, 21 Mar 2025; EMA/PE/0000232765 (sargramostim, Treatment of pulmonary alveolar proteinosis): P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), 14 Apr 2025; +8 more","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-paediatric_investigation_plans-output-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/26/3215 positive 25 Mar 2026: Treatment of pulmonary neuroendocrine carcinoma; EU/3/24/2928 positive 28 Jun 2024: Treatment of pulmonary alveolar proteinosis","rule":"An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-orphan_designations-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Opdivo: authorised since 19 Jun 2015; Opdualag: authorised since 15 Sept 2022; Yervoy: authorised since 13 Jul 2011; Imreplys: authorised since 21 Aug 2025, exceptional circumstances; +1 more","rule":"An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"fda_orphan","label":"FDA orphan designation","value":"not published","detail":"FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link","rule":"Would be: an FDA orphan designation names the drug","source":{"label":"FDA orphan designations search","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/","date":""},"context":[]},{"id":"fda_ped_approval","label":"FDA pediatric oncology approval","value":"yes","detail":"Ipilimumab [Yervoy], 8 Apr 2025: In combination with nivolumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC); Ipilimumab [Yervoy], 15 Feb 2023: As a single agent or in combination with nivolumab, for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older; Nivolumab and hyaluronidase-nvhy [Opdivo Quantig], 24 Nov 2025: Treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous nivolumab and ipilimumab combination therapy; +9 more","rule":"FDA's Pediatric Oncology Drug Approvals table names the drug","source":{"label":"FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03)","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals","date":"2026-11-11T22:02:57.922Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"316 interventional studies of Ipilimumab, Nivolumab, Sargramostim include patients under 18; 101 are recruiting, not yet recruiting or active","rule":"The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age","source":{"label":"ClinicalTrials.gov search","url":"https://clinicaltrials.gov/search?intr=%22Ipilimumab%22+OR+%22Nivolumab%22+OR+%22Sargramostim%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T22:02:57.931Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Rare pediatric disease voucher","text":"FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news.","source":{"label":"FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs","url":"https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs","date":"2026-11-11"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"National Cancer Institute (NCI) (academic or other)","source":{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571","date":"2026-11-11T22:02:57.854Z"}},{"label":"principal investigator","text":"Frank S Hodi, ECOG-ACRIN Cancer Research Group","source":{"label":"Person page","url":"/person/Frank%20S%20Hodi","date":"2026-11-11T22:02:57.854Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT02339571","url":"https://clinicaltrials.gov/study/NCT02339571","date":"2026-11-11T22:02:57.854Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T22:02:57.854Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T22:02:57.844Z"}