H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Small Cell Lung Cancer or Extensive-stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase I: Confirmation of Recommended Phase II DosePrimary· 13 weeks
Recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. Investigators will initially enroll 6 patients and wait until completion of the 13-week safety observation period following initiation of ipilimumab + nivolumab combination treatment.
PFS is defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration (as defined above) or death due to any cause.
Group
Value
95% CI
Combination Therapy
4.5
2.7 – 4.6
Overall Survival (OS)Secondary· 1 year
OS is defined as the duration from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Group
Value
95% CI
Combination Therapy
11.7
4.7 – 16.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Combination Therapy
Serious: 13/21 (62%)
Deaths: 6/21
Serious adverse events (34 terms)
Reaction
System
Combination Therapy
Neoplasms benign, malignant and unspecified -Other
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Lung Infection
Infections and infestations
—
Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy.
The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of platinum based chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06769126 — Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 20 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03043599.