Table 3.
Ongoing BiTE therapy clinical trials in melanoma.
| Study Name (NCT Number) | Trial Stage | Therapeutic Approach | Enrollment | Disease/Stage |
|---|---|---|---|---|
| (NCT05315258) | Phase II (Recruiting) | Tebentafusp | 850 | Cutaneous melanoma with molecular relapsed disease (MRD) and uveal melanoma with MRD |
| (NCT05549297) | Phase II/III (Recruiting) | Tebentafusp as a monotherapy or in combination with pembrolizumab vs investigator’s choice | 460 | HLA-A*02:01-positive with previously treated non-ocular advanced melanoma |
| TEBE-AM (NCT05549297) | Phase II/III (Recruiting) | Tebentafusp monotherapy in combination with pembrolizumab vs. standard of care | 460 | Previously treated advanced melanoma |
| (NCT06070012) | Phase II (Not yet recruiting) | Tebentafusp | 44 | Previously untreated metastatic uveal melanoma with an integrated circulating tumor DNA biomarker |
| (NCT06414590) | Phase II (Not yet recruiting) | Neoadjuvant tebentafusp | 19 | Locally Advanced, Unresectable Primary Uveal Melanoma |
| (NCT03070392) | Phase II (Active, not recruiting) | Tebentafusp vs investigator’s choice (Dacarbazine, ipilimumab, or pembrolizumab) | 378 | Previously untreated advanced uveal melanoma |
| (NCT02570308) | Phase I/II (Completed) | Tebentafusp | 146 | Advanced uveal melanoma with (HLA)-A*0201 positive |
| PRISM-MEL-301 (NCT06112314) | Phase III (Recruiting) | IMC-F106C plus nivolumab vs. nivolumab and relatlimab vs. nivolumab alone | 680 | Previously untreated advanced melanoma |
| ACTengine (NCT03686124) | Phase I (Recruiting) | IMA203/IMA203CD8 products, with or without combination nivolumab | 186 | Solid tumors that express PRAME |
| (NCT05973487) | Phase I (Recruiting) | T-Plex, an autologous customized TCR therapy targeting specific peptide/HLA antigens | 100 | Locally advanced (unresectable) or metastatic solid tumors |