Table 1.
TIL therapy ongoing clinical trials in melanoma.
| Study Name (NCT Number) | Trial Stage | Therapeutic Approach | Enrollment | Disease/Stage |
|---|---|---|---|---|
| ACTME (NCT04330430) | Phase I/II (Active, Not Recruiting) | One cohort was given a combination of TILs and anti-PD-1 and the second was given TILs and anti-PD-1 with PEG-IFNa | 34 | Unresectable stage III–IV melanoma |
| TIL (NCT02278887) |
Phase III (Active, Not Recruiting) | TIL treatment vs Ipilimumab | 168 | Unresectable stage III–IV melanoma |
| (NCT05176470) | Phase I (Active, Not Recruiting) | Neoadjuvant administration of TIL therapy with Pembrolizumab | 2 | Stage IIIB-D to stage IV melanoma |
| (NCT01005745) | N/A (Active, Not Recruiting) | TILs with high dose IL-2 | 19 | Unresectable metastatic stage IV melanoma or stage III in-transit or regional nodal disease |
| LN-144 (NCT02360579) | Phase II (Active, Not Recruiting) | Lifileucel | 178 | Unresectable or metastatic (Stage IIIc or IV) melanoma |
| (NCT05470283) | Phase I (Active, Not Recruiting) | TILs engineered with membrane-bound IL15 plus acetazolamide | 21 | Unresectable stage III–IV melanoma |
| mMEL (NCT03475134) |
Phase I (Active, Not Recruiting) | TILs followed with or without nivolumab rescue | 18 | Unresectable stage IIIc–IV melanoma who have progressed on at least 1 standard first-line therapy |
| TUNINTIL (NCT04217473) |
Phase I (Active, Not Recruiting) | TNFalpha and IL-2 coding oncolytic adenovirus TILT-123 and TILs therapy | 17 | Previously treated refractory or recurrent stage 3–4 melanoma |
| (NCT01659151) | Phase II (Active, Not Recruiting) | Vemurafenib with TILs therapy and high dose IL-2 | 17 | Unresectable metastatic stage IV melanoma or stage III in-transit or regional nodal disease |
| (NCT00338377) | Phase II (Active, Not Recruiting) | TIL therapy with or without dendritic cell immunization | 1230 | Metastatic melanoma, uveal melanoma, or stage III in-transit or regional nodal disease |
| (NCT01319565) | Phase II (Active, Not Recruiting) | TILs plus IL-2 following either a non-myeloablative Lymphocyte Depleting chemotherapy regimen alone or in combination with 12Gy total body irradiation | 102 | Metastatic melanoma with at least one lesion resectable for TIL generation |
| (NCT01701674) | N/A | TILs plus IL-2 with Ipilimumab | 13 | Unresectable metastatic stage IV melanoma or stage III in-transit or regional nodal disease |
Abbreviations: N/A = not available.