Clinical trial · no report yet · Phase 2
NCT05327530
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
- NCT05327530 ↗
- Active not recruiting
- EMD Serono Research & Development Institute, Inc.
- 20 commentary sources found
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 15 | |
| Podcasts | 3 | |
| YouTube | 2 |
The trial
ClinicalTrials.gov- Official title
- A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)
- Phase
- Phase 2
- Status
- Active not recruiting
- Conditions
- Locally Advanced or Metastatic Urothelial Carcinoma
- Interventions
- Avelumab; Sacituzumab Govitecan (SG); M6223; NKTR-255; JB100
- Arms
- Avelumab · Experimental
- Avelumab + Sacituzumab Govitecan (SG) · Experimental
- Avelumab + M6223 · Experimental
- Group D: Avelumab + NKTR-255 · Experimental
- JB100 (NCT02603432) · Other
- Enrollment
- 256
- Primary outcomes
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs)
- Sponsor
- EMD Serono Research & Development Institute, Inc. with Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics
- Start
- Aug 17, 2022
- Primary completion
- Jun 20, 2025
- Results posted
- Yes
- Registry record
- NCT05327530 · updated Sep 28, 2026
Publications
linked from the registry- Naing A, McKean M, Tolcher A, Victor A, Hu P, Gao W, Nogueira Filho MAF, Kitzing T, Gleicher S, Holland D, Richter E, Tadjalli-Mehr K, Siu LL. TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa in patients with advanced solid tumors: a first-in-human, phase 1, dose-escalation trial. J Immunother Cancer. 2025 Feb 10;13(2):e010584. doi: 10.1136/jitc-2024-010584. PubMed 39929671
- Hoffman-Censits J, Grivas P, Powles T, Hawley J, Tyroller K, Seeberger S, Guenther S, Jacob N, Mehr KT, Hahn NM. The JAVELIN Bladder Medley trial: avelumab-based combinations as first-line maintenance in advanced urothelial carcinoma. Future Oncol. 2024 Feb;20(4):179-190. doi: 10.2217/fon-2023-0492. Epub 2023 Sep 6. PubMed 37671748