Table 10.
Selected current trials of checkpoint inhibitors in MM.
| PD-1 Inhibitors | ||||
|---|---|---|---|---|
| Trial ID (References) | Drugs | Phase | Enrollment (N) | Trial Title |
| NCT05204160 | Pembro | II | 30 | Study of Pembrolizumab as Salvage Therapy Among MM Patients Progressing on CAR-T Cell Therapy |
| NCT05191472 [251] | Pembro | II | 25 | Study of Pembrolizumab in MM Patients Relapsing After or Refractory to Anti-BCMA CAR-T Therapies |
| NCT02636010 | Pembro | II | 20 | Multicenter, Open Label, Clinical Trial of Pembrolizumab as Consolidation Therapy in MM Patients with Residual Disease After Treatment |
| NCT03267888 | Pembro | I | 26 | Pilot Study of Pembrolizumab and Single-Fraction, Low-Dose, Radiation Therapy in Patients with RRMM |
| NCT02331368 | Pembro | II | 32 | Multi-center Study of Anti-Programmed-Death-1 During Lymphopenic State After High-Dose Chemotherapy and ASCT for MM |
| NCT05514990 | Pembro + Bort + Dex +/− Pelareorep | I/II | 42 | Study of Standard Doses of Bortezomib and Pembrolizumab ± Reovirus (Pelareorep) Combination Therapy in Patients with RRMM (AMBUSH Study) |
| NCT02906332 [252] | Pembro + Len + Dex | II | 16 | Trial of Pembrolizumab + Lenalidomide + Dexamethasone as Post-ASCT Consolidation in Patients with High-risk MM |
| NCT03848845 [62] | Pembro + BelMaf | I/II | 41 | Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination with Pembrolizumab in Subjects with RRMM (DREAMM 4) |
| NCT02880228 | Pembro + Len + Dex | II | 11 | Trial of Pembrolizumab, Lenalidomide, and Dexamethasone for Initial Therapy of NDMM Eligible for ASCT |
| NCT03506360 | Pembro + Ixaz + Dex | II | 13 | Trial of Pembrolizumab, Ixazomib, and Dexamethasone for RRMM |
| NCT03194867 [246] | Isa +/− Cem | I/II | 106 | Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination with Cemiplimab in Patients with RRMM |
| NCT03184194 | Niv + Dara +/− Ctx | II | 62 | Study of Nivolumab Combined with Daratumumab with or without Low-dose Cyclophosphamide in RRMM |
| NCT03605719 | Niv + Carf + Dex +/− Pelareorep | I | 23 | Dexamethasone, Carfilzomib, and Nivolumab with Pelareorep for RRMM |
| NCT04119336 | Niv + Ixaz + Ctx + Dex | II | 50 | Study of Nivolumab in Combination with Ixazomib, Cyclophosphamide, and Dexamethasone in RRMM |
| NCT02726581 | Pom + Dex +/− Niv | III | 170 | Open-Label, Randomized Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in RRMM |
| NCT02681302 [240] a | Niv + Ipil | I/II | 35 | Study of Combined Check Point Inhibition After ASCT in Patients at High Risk for Post-transplant Recurrence |
| NCT02612779 | (Niv + Elo) vs. (Niv + Elo + Pom + Dex) | II | 74 | Study of Elotuzumab in Combination with Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination with Nivolumab in Patients with RRMM to Prior Treatment with Lenalidomide. |
| NCT03292263 | Mel + Niv | I/II | 30 | ASCT with Nivolumab in Patients with MM |
| NCT01592370 [244] | Niv vs. (Niv + Ipil) vs. (Niv + Liri) vs. (Niv + Dara + Pom) + Dex) vs. (Niv + Dara) | I/Ii | 316 | An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients with MM |
| PD-L1 Inhibitors | ||||
| NCT03312530 [245] | (Cobi + Atez) vs. (Cobi + Ven +/− Atez) | I/II | 49 | Study of Cobimetinib Administered as Single Agent and in Combination with Venetoclax, with or without Atezolizumab, in Patients with RRMM |
| NCT02431208 [253] | (Atez + Len) vs. (Atez + Dara) vs. (Atez + Dara + Len) vs. (Atez + Dara + Pom) vs. (Dara + Pom + Dex) | I | 85 | Study of the Safety and Pharmacokinetics of Atezolizumab Alone or in Combination with an Immunomodulatory Drug and/or Daratumumab in Patients with RRMM and ASCT |
| CD47 Inhibitors | ||||
| NCT04892446 [249,254] | (Mag + Dara) vs. (Mag + Pom + Dex) vs. (Mag + Carf + Dex) vs. (Mag + Bort + Dex) | II | 153 | Multi-Arm Study of Magrolimab Combinations in Patients with RRMM |
| NCT04445701 [250] | AO-176 vs. (AO-176 + Dex +/− Bort) | I/II | 157 | Dose Escalation Safety and Tolerability Study of AO-176 as Monotherapy and in Combination with Bortezomib and Dexamethasone in Adults with RRMM |
| NCT05139225 | TTI-622 + Dara-Hyal | I | 32 | Study Of The Combination Of CD47 Blockade with SIRP-Alpha FC Fusion Proteins (TTI-622) And Daratumumab Hyaluronidase-fihj For Patients with RRMM |
ASCT = autologous stem cell transplantation; Atez = atezolizumab; BelMaf = belantamab mafodotin; Bort = bortezomib; Cem = cemiplimab; Carf = carfilzomib; Cobi = cobimetinib; Ctx = cyclophosphamide; Dara = daratumumab; Dex = dexamethasone; Elo = elotuzumab; Hyal = hyaluronidase; Ipil = ipilimumab; Isa = isatuximab; Ixaz = ixazomib; Len = lenalidomide; Mag = magrolimab; Mel = melphalan; MM = multiple myeloma; NDMM = newly diagnosed multiple myeloma; Niv = nivolumab; Pembro = pembrolizumab; Pom = pomalidomide; RRMM = relapsed and/or refractory multiple myeloma; Ven = venetoclax. a The study includes patients with lymphomas and high-risk recurrent MM.