Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Sacituzumab govitecan

Avelumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

Participants will receive avelumab intravenous infusion at a dose of 800 milligrams (mg) once every 2 weeks (Q2W) until unacceptable toxicity, withdraw consent or initiation of a new treatment.

Participants will receive sacituzumab govitecan intravenous infusion at dose of 10 milligrams per kilogram (mg/kg) of body weight once a week (Q1W) on Day 1 and 8 of 21-day treatment cycles, in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.

Sacituzumab Govitecan

Participants will receive M6223 (anti-T cell-immuno-receptor with Ig and ITM domains \[anti-TIGIT\]) intravenous infusion at dose of 1600 mg Q2W in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.

M6223

Participants will receive NKTR-255 intravenous infusion at a dose of 3 micrograms per kilogram body weight (mcg/kg) once every 4 weeks (Q4W) in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.

NKTR-255

US Medical Information

Communication Center

Saqib Abbasi

Jean Hoffman Censits

Jaswinder J Singh

Petros Grivas

Sunil Rangarajan

Christos Kyriakopoulos

Ganessan Kichenadasse

Cameron McLaren

Shirley Wong

Andrew J Weickhardt

Annabel Smith

Wei Chua

James Lynam

Andrew G Hill

Alexander Guminski

Alison Y Zhang

Megan Crumbaker

Wesley Teurfs

Wim Demey

Nieves Martinez Chanza

Sylvie Rottey

Philip Debruyne

Frederic Forget

Pierre Freres

Anna K Seitz

Marco Iafolla

Catherine Sperlich

Normand Blais

Christina M Canil

Dorthe Yakymenko

Andreas Carus

Remy Delva

Guilhem Roubaud

Elodie Coquan

Christophe Tournigand

Eric Voog

Aude Flechon

Jean Laurent Deville

Nadine Houede

Olivier Huillard

Nicolas Isambert

Brigitte Laguerre

Frederic Rolland

Louis Marie Dourthe

Philippe Barthelemy

Herbert Sperling

Viktor Gruenwald

Severine Banek

Georgios Gakis

Katrin Schlack

Rausch Steffen

Marinos Tsiatas

Flora Zagouri

Aristotelis Bamias

Loukas Kontovinis

Francesco Massari

Lorenzo Antonuzzo

Ugo De Giorgi

Valentina Guadalupi

Andrea Necchi

Michele Caruso

Rosa Tambaro

Fabio Calabro

Marco Maruzzo

Luca Galli

Francesco Carrozza

Linda Cerbone

Giampaolo Tortora

Evaristo Maiello

Sergio Bracarda

Hyo Jin Lee

Ho Kyung Seo

SE HYUN KIM

Jae Lyun Lee

Se Hoon Park

Miso Kim

Sang Joon Shin

In Ho Kim

Marta Gonzalez Cordero

Oscar Reig Torras

Jose Pablo Maroto Rey

Alejo Rodriguez-Vida

Begona Perez Valderrama

Maria Jose Mendez Vidal

Federico Vazquez Mazon

Sergio Vazquez Estevez

Jose Angel Arranz Arija

Mariona Figols Gorina

Isabel Chirivella Gonzalez

Yu Li Su

Shu-Pin Huang

Hsi-Chin Wu

Chien-Liang Li

Medical Responsible

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.

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

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)

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics

EMD Serono Research & Development Institute, Inc.

Atezolizumab

Participants will receive an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) or every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.

Participants will receive an IV infusion of bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) until confirmed disease progression.

Bintrafusp alfa

Participants will receive an IV infusion of M6223 at escalated doses Q2W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression.

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.

First in Human Study of M6223

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

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Merck KGaA, Darmstadt, Germany

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Locally Advance...	Avelumab Sacituzumab Gov... M6223 NKTR-255	18 Years -	EMD Serono
First in Human Study of M6223	NCT04457778	Metastatic Soli...	M6223 Bintrafusp alfa M6223	18 Years -	EMD Serono

Spots Global Cancer Trial Database for m6223

Every month we try and update this database with for m6223 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for m6223

Every month we try and update this database with for m6223 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for m6223 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.