Table 2.
Ongoing clinical trials and future directions of development in bladder cancer.
| Trial name (ClinicalTrials.gov identifier) | Brief description | Completion by |
|---|---|---|
| JAVELIN medley: a study of avelumab in combination with other cancer immunotherapies in advanced malignancies (NCT02554812) |
Phase Ib/II, open-label, multicenter, study of avelumab in combination with other immune modulators in adult patients with locally advanced or metastatic solid tumors Arm A: avelumab plus utomilumab (4-1BB agonist mAb) Arm B: avelumab plus PF-04518600 (OX40 agonist mAb) Arm C: avelumab plus PD 0360324 (M-CSF mAb) Arm D: avelumab plus utomilumab plus PF-04518600 |
May 2020 |
| JAVELIN PARP medley: avelumab plus talazoparib in locally advanced or metastatic solid tumors (NCT03330405) |
Phase Ib/II study to evaluate safety and antitumor activity of avelumab in combination with the poly (adenosine diphosphate ribose) polymerase (Parp) inhibitor talazoparib in patients with locally advanced or metastatic solid tumors | March 2020 |
| JAVELIN Bladder 100: a study of avelumab in patients with locally advanced or metastatic urothelial cancer (NCT02603432) |
Phase III, multicenter, randomized, open-label, parallel-arm study of avelumab plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after completion of first-line platinum-containing chemotherapy | July 2020 |
| PAVE-1: a dose-escalation and confirmation study of PT-112 in advanced solid tumors in combination with avelumab (NCT03409458) |
Phase Ib/IIa, open-label, multicenter, nonrandomized, dose-escalation study of PT-112, a novel platinum-pyrophosphate agent, in combination with avelumab in selected advanced solid tumors | May 2020 |
| JAVELIN chemotherapy medley: safety and efficacy study of avelumab plus chemotherapy with or without other anticancer immunotherapy agents in patients with advanced malignancies (NCT03317496) |
Phase Ib/II, open-label, multicenter, safety and clinical activity study of avelumab in combination cisplatin and gemcitabine in patients with cisplatin-eligible urothelial cancer (cohort A2). | October 2020 |
| A study combining eribulin mesylate with avelumab in cisplatin-ineligible metastatic urothelial cell cancer patients (NCT03502681) | Phase Ib, open-label, with expansion cohort of combination therapy with eribulin mesylate and avelumab in platinum-ineligible urothelial carcinoma patients | June 2019 |
| A combination of avelumab and taxane (AVETAX) for urothelial cancer (NCT03575013) | Phase Ib, open-label study of avelumab in combination with docetaxel after failure of first-line platinum-containing chemotherapy regimen | Not yet recruiting |
| JAVELIN medley VEGF: a study of avelumab in combination with axitinib in non-small cell lung cancer or urothelial cancer (NCT03472560) | Phase II, open-label, multi-institutional study of avelumab in combination with axitinib in cisplatin-ineligible patients | July 2020 |
| Safety and efficacy study of avelumab plus chemotherapy with or without other anticancer immunotherapy agents in patients with advanced malignancies (NCT03317496) | Phase Ib/II, open-label, multi-institutional study of avelumab in combination with first-line platinum-based chemotherapy | October 2019 |
| QUILT-3.048: NANT urothelial cancer vaccine: combination immunotherapy in subjects with urothelial cancer who have progressed on or after chemotherapy and PD-1/PD-L1 therapy (NCT03197571) | Phase Ib/II, open-label study of NANT urothelial cancer vaccine combination immunotherapy with avelumab in patients with urothelial cancer having failed prior anti-PD-1/PD-L1 therapies | January 2019 |
| A window-of-opportunity trial: avelumab in nonmetastatic muscle-invasive bladder cancer (NCT03498196) | Pilot, open-label study of avelumab after TURBT of a muscle-invasive urothelial cancer prior to cystectomy | Not yet recruiting |
| Trial of intratumoral administration of recombinant vesicular stomatitis virus monotherapy and in combination with avelumab in patients with refractory solid tumors (NCT02923466) | Phase Ib study of combination intratumoral oncolytic virus with systemic avelumab in patients with advanced solid tumors | January 2019 |
PD-L1, programmed cell-death ligand 1; PFS, progression-free survival; TURBT, transurethral resection of bladder tumor; VEGF, vascular endothelial growth factor.