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)

The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

Start Date17 Aug 2022

Sponsor / Collaborator

EMD Serono Research & Development Institute, Inc.

[+1]

NCT04457778 / CompletedPhase 1

Phase I, First-in-Human, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M6223, an Inhibitor of TIGIT, as Single Agent and in Combination With Bintrafusp Alfa (Anti-PDL1/ TGFß Trap) in Participants With Metastatic or Locally Advanced Solid Unresectable Tumors

The main purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks (Q2W) regimen and the every 3 weeks (Q3W) regimen and of M6223 combined with bintrafusp alfa (Part 1B) for Q2W regimen in participants with metastatic or locally advanced solid unresectable tumors.

Start Date10 Jul 2020

Sponsor / Collaborator

EMD Serono Research & Development Institute, Inc.

[+1]

100 Clinical Results associated with M6223

100 Translational Medicine associated with M6223

100 Patents (Medical) associated with M6223

Literatures (Medical) associated with M6223

01 Feb 2024·Future Oncology

The JAVELIN Bladder Medley Trial: Avelumab-Based Combinations as First-Line Maintenance in Advanced Urothelial Carcinoma

Article

Author: Hawley, Jessica ; Jacob, Natalia ; Hoffman-Censits, Jean ; Hahn, Noah M ; Mehr, Keyvan Tadjalli ; Powles, Thomas ; Guenther, Silke ; Seeberger, Sonja ; Grivas, Petros ; Tyroller, Karin

Results from JAVELIN Bladder 100 established avelumab (anti–PD-L1) first-line maintenance as the standard-of-care treatment for patients with advanced urothelial carcinoma (UC) that has not progressed with first-line platinum-based chemotherapy. We describe the design of JAVELIN Bladder Medley (NCT05327530), an ongoing phase II, multicenter, randomized, open-label, parallel-arm, umbrella trial. Overall, 252 patients with advanced UC who are progression-free following first-line platinum-based chemotherapy will be randomized 1:2:2:2 to receive maintenance therapy with avelumab alone (control group) or combined with sacituzumab govitecan (anti–Trop-2/topoisomerase inhibitor conjugate), M6223 (anti-TIGIT) or NKTR-255 (recombinant human IL-15). Primary end points are progression-free survival per investigator and safety/tolerability of the combination regimens. Secondary end points include overall survival, objective response and duration of response per investigator, and pharmacokinetics.

100 Deals associated with M6223

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Solid Tumor	Phase 1	CA	EMD Serono Research & Development Institute, Inc.	10 Jul 2020
Metastatic Solid Tumor	Phase 1	US	EMD Serono Research & Development Institute, Inc.	10 Jul 2020
Solid tumor	Preclinical	US	Merck KGaA	10 Jul 2020
Solid tumor	Preclinical	CA	Merck KGaA	10 Jul 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04457778 (AACR2024) Manual	Phase 1	Solid tumor	58	M6223	(kfaqxlmokl) = Overall, two dose-limiting toxicities were observed: a grade 3 adrenal insufficiency (M6223, 900 mg) and a grade 3 anemia (M6223+BA, 300 mg; unrelated to M6223). qsnypgfibk (pbfwwkqsaw ) View more	Positive	05 Apr 2024
				M6223+bintrafusp alfa
NCT04457778 (ESMO2022) Manual	Phase 1	Unresectable Solid Neoplasm TIGIT	41	M6223	(gbbuhmasah) = qgmilorogr hdfxrtsouy (mfqnzpwjmz ) View more	Positive	10 Sep 2022
				M6223+bintrafusp alfa	(gbbuhmasah) = tvlmmywytb hdfxrtsouy (mfqnzpwjmz ) View more

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