Table 4.
Ongoing industry-sponsored pediatric studies including patients with melanoma.
| Study # | Abbreviated Study Description | Centers | Age | Pts | Sponsor | PIP # |
|---|---|---|---|---|---|---|
| NCT02332668 | Pembrulizumab in advanced melanoma or advanced R/R PDL1–positive solid tumors or lymphoma | 45 | 6-month–17 y | 310 | MSD | EMEA-001474-PIP01-13 |
| NCT01677741 | Dabrafenib in advanced BRAF V600 mutation–positive solid tumors | 27 | 1–17 y | 86 | GSK | EMEA–001147-PIP01-11-M03 |
| NCT01962103 | Paclitaxel DF & PE in R/R solid tumors | 20 | 6-month–17 y Ph1 | 107 | Celgene | EMEA-001308-PIP01-12 |
| 2–24 y Ph2 | ||||||
| EUdraCT 2014-004685-25 | Cobimetinib DE, S & PK in previously treated solid tumors | 41 | 1–17 y (DES) | 50 | Roche | EMEA-001425-PIP01-13-M01 |
| 6–30 y (ES) | ||||||
| NCT02756845 | S&E of talimogene laherparepvec in melanoma and advanced non-CNS tumors | 17 | 12–21 y Ph1 | 18 | Amgen | EMEA-001251-PIP01-11-M03 |
| 2–11 y Ph2 |
Abbreviations in alphabetic order: CNS—central nervous system; DE—dose escalation; DES—dose escalation study; DF—dose finding; ES—expansion study; GSK—GlaxoSmithKline; MSD—Merck, Sharp & Dome; PE—preliminary; Ph1—phase 1; Ph2—phase 2; PK—pharmacokinetics efficacy; Pts—Patients; Roche—Hoffman-La Roche; R/R—recurrent or refractory; S—safety; y—years.