Table 5.
Examples of combination phase III monoclonal antibody immunotherapy trials in melanoma. Information sourced from ClinicalTrials.gov.
| Indication | Trial number | Combination therapy | Study design | Target | Status |
|---|---|---|---|---|---|
| DUAL MONOCLONAL ANTIBODY THERAPIES | |||||
| Previously untreated, unresectable or metastatic melanoma | NCT02905266 | Nivolumab + ipilimumab | Arm A: nivolumab and ipilimumab concomitant administration followed by nivolumab monotherapy Arm B: nivolumab and ipilimumab sequential administration followed by nivolumab monotherapy | Anti-PD-1 + anti-CTLA-4 | Active, not recruiting |
| Complete resection of stage IIIB/C/D or stage IV melanoma | NCT03068455 (CheckMate 915) | Nivolumab + ipilimumab | Arm A: nivolumab + ipilimumab Arm B: nivolumab | Anti-PD-1 + anti-CTLA-4 | Active, not recruiting |
| Previously untreated, unresectable or metastatic melanoma | NCT02714218 | Nivolumab + ipilimumab | Arm A: nivolumab 3 mg/kg IV + ipilimumab 1 mg/kg IV Arm B: ipilimumab 3 mg/kg IV + nivolumab 1 mg/kg IV Arm C: nivolumab 6 mg/kg IV + ipilimumab 1 mg/kg | Anti-PD-1 + anti-CTLA-4 | Active, not recruiting |
| First-line for advanced melanoma | NCT02599402 (CheckMate 401) | Nivolumab + ipilimumab | Arm A: nivolumab + ipilimumab Arm B: nivolumab | Anti-PD-1 + anti-CTLA-4 | Active, not recruiting |
| Unresectable or metastatic melanoma | NCT03470922 | Nivolumab +relatlimab | Arm A: relatlimab + nivolumab Arm B: nivolumab | Anti-PD-1 + LAG-3 inhibitor | Recruiting |
| COMBINED MONOCLONAL ANTIBODY AND TYROSINE KINASE INHIBITORS | |||||
| Stage III-IV BRAFV600 melanoma | NCT02224781 | Ipilimumab and nivolumab + dabrafenib and trametinib | Arm A: ipilimumab and nivolumab then dabrafenib and trametinib Arm B: dabrafenib and trametinib then ipilimumab and nivolumab | Anti-CTLA-4 and anti-PD-1 + BRAF inhibitor and MEK inhibitor | Recruiting |
| Previously untreated BRAFV600 mutation-positive patients with metastatic or unresectable locally advanced melanoma | NCT02908672 | Atezolizumab + cobimetinib + vemurafenib | Arm A: atezolizumab + cobimetinib + vemurafenib + vemurafenib placebo Arm B: atezolizumab placebo + cobimetinib + vemurafenib | Anti-PD-1 + MEK inhibitor + BRAF inhibitor | Active, not recruiting |
| Previously untreated advanced BRAFV600 wild-type melanoma | NCT03273153 | Atezolizumab + cobimetinibPembrolizumab | Arm A: atezolizumab + cobimetinib Arm B: pembrolizumab | Anti-PD-L1 + MEK inhibitorsAnti-PD-1 | Recruiting |
| MONOCLONAL ANTIBODY THERAPIES COMBINED WITH OTHER AGENTS | |||||
| Anti-PD-1 refractory melanoma | NCT03445533 (ILLUMINATE-301) | Ipilimumab + IMO-2125 | Arm A: ipilimumab Arm B: ipilimumab + IMO-2125 | Anti-CTLA-4 + TLR9 agonist | Recruiting |
| Unresectable or metastatic melanoma | NCT02752074 (Keynote-252 / ECHO-301) | Pembrolizumab + epacadostat | Arm A: pembrolizumab + epacadostat Arm B pembrolizumab + placebo | Anti-PD-1 + IDO1 inhibitor | Active, not recruiting |
| Untreated unresectable stage III or IV melanoma | NCT00324155 | Dacarbazine + ipilimumab | Arm A: dacarbazine + ipilimumab Arm B: dacarbazine + placebo | Chemotherapy alkylating agent + anti-CTLA-4 | Completed |
| Unresected melanoma | NCT02263508 (KEYNOTE-034) | Pembrolizumab + T-Vec | Arm A: pembrolizumab + talimogene laherparepvec Arm B: pembrolizumab + placebo | Anti-PD-1 + oncolytic herpes virus | Active, not recruiting |
| Unresectable or metastatic melanoma | NCT03301636 (NLG2107) | Pembrolizumab/nivolumab + indoximod | Arm A: pembrolizumab + indoximiod Arm B: pembrolizumab + placebo Arm C: nivolumab + indoximiod Arm D: nivolumab + placebo | Anti-PD-1 + IDO inhibitor | Recruiting |