Table 1.
Active clinical trials testing the combination of ipilimumab and radiotherapy.
| Clinicaltrials.gov identifier | Disease site | Design | Phase | Primary outcome measure | Radiation dose/timing | Institution(s) |
|---|---|---|---|---|---|---|
| NCT01557114 | Melanoma (stage III/IV) | 1 arm: ipi with RT | I | Maximum tolerated dose | 9, 15, 18, 24 Gy in three fractions with concurrent ipi | Gustave Roussy |
| NCT01996202 | Melanoma (locally advanced or unresectable) | Two cohorts: (A) resected high-risk patients or (B) neoadjuvant, locally advanced | I | Safety and tolerability | No data provided | Duke University |
| NCT01565837 | Melanoma (oligometastatic but unresectable) | 1 arm: ipi with SRT | II | Safety and tolerability | SRT one to five lesions with third cycle of ipi | Comprehensive cancer centers of Nevada |
| NCT01703507 | Melanoma (brain metastases) | Two arms: (A) ipi with WBRT or (B) ipi with SRS | I | Maximum tolerated dose | (A) WBRT weeks 1 and 2 (B) SRT week 1. Ipi delivered weeks 1, 4, 7, 10 | Thomas Jefferson University |
| NCT01449279 | Melanoma (stage IV) | One arm: ipi with RT | I | Safety | Pallitive RT within 2 days of ipi | Stanford |
| NCT01689974 | Melanoma (stage IV) | Two arms, randomized: ipil ± RT | II | Tumor response | 6 Gy × 5 given on consecutive treatment days starting on day 1 with Ipi on day 4 | New York University |
| NCT01497808 | Melanoma (metastatic) | One arm: ipi with SRT | I/II | Dose-limiting toxicity | SRT 1 lesion prior to ipi | University of Pennsylvania |
| NCT01970527 | Melanoma (stage IV) | One arm: SRT before ipi | II | Immune-related response, toxicity and survival | 3 fractions of SRT between days 1–13 followed by ipi | University of Washington/NCI |
| NCT01935921 | Head and neck (stage III–IVB) | One arm: ipi, cetuximab and RT | I | Safety and tolerability | IMRT 5 days a week for 7 weeks with cetuximab and ipi at week 4 for 3, 21 day courses | NCI |
| NCT01711515 | Cervical cancer (stage IB–IVA) | One arm: ipi, cisplatinum and RT | I | Safety and tolerability | Standard of care chemoradiation followed by 4, 21 day cycles of ipi within 2 weeks | NCI |
| NCT02107755 | Melanoma (metastatic) | One arm: ipi followed by SRT | II | Progression-free survival | Ipi weeks 1, 4, 7, 10 with SRT two to three fractions on week 5–6 | Ohio State Comprehensive Cancer Center |
| NCT02115139 | Melanoma (brain metastases) | One arm: ipi followed by WBRT | II | One year survival | Ipi weeks 1, 4, 7, 10 with WBRT between cycles 1 and 2 | Grupo Español Multidisciplinar de Melanoma |
| NCT01860430 | Head and neck (stage III–IV) | One arm: IMRT with cetuximab and dose escalating ipi | II | Maximum tolerated dose | IMRT weeks 2–8 (70–74 Gy), Cetuximab weeks 1–8, ipi weeks 1, 5, 8, 11, 14 | University of Pittsburgh/NCI |
| NCT02097732 | Melanoma (Brain Metastases) | Two arms: (A) SRT followed by ipi (B) ipi then SRT then ipi | II | Progression-free survival | (A) SRT followed by 4 cycles ipi (B) 2 cycles of ipi then SRT then 2 cycles ipi | University of Michigan Cancer Center |
Ipilumimab(ipi); Radiation Therapy (RT); Sterotactic Radiotherapy (SRT); Stereotactic Radiosurgery (SRS); Whole Brain Radiotherapy (WBRT); Intensity Modulated Radiation Therapy (IMRT); National Cancer Institute (NCI).