Table 4.
Ongoing clinical trials with PD-L1 inhibitors in multiple myeloma (Atezolizumab, Durvalumab, BMS-936559).
| Title | N | Con. | Experimental arm | Identifier Phase |
|---|---|---|---|---|
| ATEZOLIZUMAB | ||||
| Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM) | 288 | RRMM | a) Atezolizumab b) c*) Atezolizumab/Lenalidomide d) Atezolizumab/Daratumumab e) Atezolizumab/Daratumumab/Lenalidomide f) Atezolizumab/Daratumumab/Pomalidomide |
NCT02431208 1 put on hold (enrolment resumed) |
| Pilot Study Of Anti-Programmed Death Ligand-1 (Anti-PD-L1, Atezolizumab) In Asymptomatic Myeloma | 20 | SMM | Atezolizumab | NCT02784483 1 suspended |
| A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma | 72 | RRMM | a) Atezolizumab/Cobimetinib b) Cobimetinib/Venetoclax c) Atezolizumab/Cobimetinib/Venetoclax |
NCT03312530 1, 2 |
| DURVALUMAB | ||||
| A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma | 138 | RRMM | a) Durvalumab b) Durvalumab/Pomalidomide c) Durvalumab/Pomalidomide/Dexamethasone |
NCT02616640 1 put on hold |
| A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Subjects With Newly Diagnosed Multiple Myeloma | 138 | NDMM | a) Durvalumab/Lenalidomide b) Durvalumab/Lenalidomide/ Dexamethasone |
NCT02685826 1 suspended |
| A Study of PVX-410, a Cancer Vaccine, and Durvalumab +/- Lenalidomide for Smoldering MM | 26 | SMM | a) Durvalumab b) Durvalumab/PVX-410 c) Durvalumab/PVX-410/Lenalidomide |
NCT02886065 1 |
| Phase 1 Study to Assess Safety & Tolerability of Tremelimumab & Durvalumab, Administered With High Dose Chemotherapy and Autologous Stem Cell Transplant | 24 | RRMM§ | Durvalumab/Tremelimumab | NCT02716805 1suspended |
| A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma (FUSIONMM-003) | 144 | RRMM | a) Durvalumab/Daratumumab b) Durvalumab/Daratumumab/ Pomalidomid/Dexamethasone |
NCT02807454 2 put on hold |
| A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (FUSION-MM-005) | 180 | RRMM | Durvalumab/Daratumumab | NCT03000452 2 suspended |
| BMS-936559 | ||||
| Safety Study of Anti-Programmed Death-Ligand 1 in Hematologic Malignancy | 110 | RRMM | BMS-936559 | NCT01452334 1 withdrawn |
RRMM - relapsed or refractory multiple myeloma; NDMM - newly diagnosed multiple myeloma; SMM - smoldering multiple myeloma; N - estimated enrolment; Con.- condition; mAb - monoclonal antibody; autoHSCT - autologous stem cell transplantation; Atezolizumab - mAb anti-PD-L1; Durvalumab - mAb anti-PD-L1; BMS-936559 - mAb anti-PD-L1; Tremelimumab - mAb anti-CTLA-4; PVX-410, tetra-peptide vaccine against XBP1, CD138, and CS1,
Atezolizumab/Lenalidomide is administrated to patients who have measurable disease after autoHSCT,
Tremelimumab or Tremelimumab/Durvalumab is administrated prior to and for 2 cycles post autoHSCT followed by up to 6 additional monthly cycles of durvalumab alone.