Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Dostarlimab

Dostarlimab will be administered as an intravenous (IV) infusion

Placebo will be administered as an IV infusion

Placebo

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Mazen Khalil

Deborah Jean Lee Wong

Ryan Kendle

Dheeraj Kodali

Justin W Tiulim

Upendra Hegde

Barbara Burtness

Irina G Veytsman

Nabil Saba

Sunil Babu

Douglas Laux

Shaker R Dakhil

Susanne M. Arnold

Najeff Waseem

William V Walsh

Douglas Adkins

Brian Henick

Christopher Aaron Lemmon

John Kaczmar

Robert D Siegel

G. Gary Tian

Ray D. Page

Jerome Goldschmidt

John Deeken

Andrea Veatch

Christian Sebastián Fuentes

Rubn Dario Kowalyszyn

Herman Perroud

Felipe Salvador Palazzo

Pedro Martin Inca Paskevicius

Dante Pascual Goy

Jorge Emilio Salinas

Juan Manuel Puig

Rosemary Habib

Michelle Katherine Nottage

Stephen John Brown

Madhu Sudan Singh

Andrew Haydon

Shivanshan Pathmanathan

Jean-Pascal Machiels

Aurelie Louvet

Marika Rasschaert

Michael Saerens

Stephanie Henry

Livia Maria Andrade

Dalvaro Oliveira de Castro Junior

Glaucio Antonio Bertollo

Elisa Fontes Ramos

Fernanda Ramos

Fabricio Pontes Grando

Celio Kussumoto

Gustavo Pinto

Luiza Ferreira

Gilberto de Castro Junior

Nicole Chau

Baskoro Kartolo

Anna Spreafico

Khashayar Esfahani

Sufang Qiu

Zhigang Liu

Weidong Li

Song Qu

Guangyuan Hu

Zhiwei Chang

Yaqian Han

Jingao Li

Man Hu

Peng Zhang

Lei Liu

Yulong Zheng

Xiaozhong Chen

Yan Sun

Jinsheng Hong

Yimin Liu

Jin Gao

Bingjian Huang

Jianwu Ding

Chaosu Hu

Zhendong Li

Siyang Wang

Bohuslav Melichar

Renata Soumarova

Petra Holeckova

Michaela Jirkovska

Marketa Pospiskova

Emeline Guiard

Sylvie Zanetta

Sébastien Salas

Camille Evrard

Florian Estrade

Florian Clatot

Yaovi Eric Amela

Marie-Christine Kaminsky

Johannes Doescher

Rainer Fietkau

Antoniu-Oreste Gostian

Philipp Ivanyi

Thomas Gauler

Maike de Wit

Marcus Beck

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed \>20 weeks after completion of or Death from any cause.

OS is defined as the time from date of randomization to the date of death by any cause.

Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event as per primary endpoint, however with investigator assessment per RECIST 1.1

GlaxoSmithKline

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Analgesics

Docetaxel

Ipilimumab

Interleukin-2

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Feladilimab

GSK4428859A/EOS884448 will be administered.

GSK4428859A

GSK6097608

Ani Balmanoukian

Balazs Halmos

Davey B Daniel

David R Spigel

Quincy Chu

Parneet Cheema

Adrian Sacher

Sophie Cousin

Nicolas Girard

Gerard Zalcman

David Planchard

Martin Reck

Angelo Delmonte

Manolo D'Arcangelo

Giuseppe Lo Russo

Michele Maio

Enriqueta Felip

Pilar Garrido López

Laura Medina Rodríguez

GSK Clinical Trials

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

IPD for this study will be made available via the Clinical Study Data Request site.

Overall survival will be calculated as time from randomization to death.

Objective response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.

DCR is defined as the percentage of participants with a best overall confirmed CR, PR or stable disease (SD) at any time as per disease-specific criteria.

Milestone survival rate of participants treated with experimental regimens versus SoC therapy.

CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria.

PFS is defined as time from the date of randomization to the date of disease progression or death whichever occurs earlier.

ORR is defined as the percentage of participants with a confirmed CR or PR at any time per RECIST version 1.1 criteria.

DOR is defined as the first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria.

DCR is defined as the percentage of participants with a best overall confirmed CR, PR or SD at any time as per disease-specific criteria.

Number of participants with iCR, iPR, iUPD, iCPD and iSD per modified RECIST 1.1 for immune-based therapeutics (iRECIST) criteria.

iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria.

iORR is defined as the percentage of participants with a confirmed CR or PR at any time per iRECIST criteria.

iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria.

iTeos Belgium SA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma	NCT06256588	Neoplasms, Head...	Dostarlimab Placebo	18 Years -	GlaxoSmithKline
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)	NCT03739710	Neoplasms	Docetaxel Feladilimab Ipilimumab GSK4428859A Dostarlimab GSK6097608	18 Years -	GlaxoSmithKline
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)	NCT03739710	Neoplasms	Docetaxel Feladilimab Ipilimumab GSK4428859A Dostarlimab GSK6097608	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for jemperli

Every month we try and update this database with for jemperli 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 jemperli

Every month we try and update this database with for jemperli 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 jemperli 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.