Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Laryngeal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Complement C3

Complement C3d

Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.

Xevinapant

Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2).

Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week

intensity-modulated radiation therapy (IMRT)

US Medical Information

Communication Center

Ragisha Gopalakrishnan

Ammar W Sukari

Rafi Kabarriti

Jessica Geiger

Ryan A Vaca

Marika Rasschaert

Michael Saerens

Frederic Forget

Willem Lybaert

Aron Popovtzer

Young Jin Choi

Keun-Wook Lee

Ji-Hyun Park

Hye Ryun Kim

Jung Hoon Kim

Jordi Rubio

Javier Serrano Andreu

Jaime Rubio Perez

Maria Jose Flor Oncala

Hui-Ching Wang

Ching-Yun Hsieh

Huai Cheng Huang

Muh-Hwa Yang

Medical Responsible

The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)

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

LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Pharmaceutical Solutions

Participants will receive 3 cycles of oral solution of Xevinapant (Debio 1143) at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of Xevinapant (Debio 1143) at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Xevinapant (Debio 1143)

Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week.

IMRT

Participants will receive 3 cycles of oral solution of placebo matched to Xevinapant (Debio 1143) once daily from Day 1 to 14 per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of placebo matched to Xevinapant (Debio 1143) from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Placebo

James Bonner

Robert Haddad

Zujun Li

Sara A Medek

Robert Ferris

Richard O Neal

Diego Lucas Kaen

Jorge Emilio Salinas

Alejandro Sola

Ruben D Kowalyszyn

Martin Burian

Richard F Greil

Tatiana Dragan

Jean Pascal Machiels

Carlos E Baston Silva

Fabrício Augusto Martinelli de Oliveira

Fabricio Pontes Grando

Iane F Pinto Figueiredo Lima

Fabio André Franke

Rivadavio Antunes Menacho de Oliveira

Silvio C Sales

Alan Arrieira Azambuja

Sergio Jobim de Azevedo

Katsuki Arima Tiscoski

Pedro Rafael Martins De Marchi

Jamille G Dutra

Daniel O Brito

Claudia Vaz de Melo Sette

Lucas Vieira dos Santos

Milena Perez Mak

Denis Soulieres

Yan Sun

Yajun Zhang

Xin Jiang

Yaqian Han

Liangfang Shen

Mei Feng

Lei Liu

Yue Xie

Shaojun Lin

Shaoxiong Wu

Xiaonan Sun

Xianzhong Chen

Jin Gao

Man Hu

Jingao Li

Jing Yan

Song Qu

Chaosu Hu

Pin Dong

Caigang Liu

Peiguo Wang

Kunyu Yang

Hongbing Ma

Buhai Wang

Hui Wu

Bohuslav Melichar

Katerina Lickova

Petra Holeckova

Aurore Goineau

Amaury Daste

Ulrike Schick

Juliette Thariat

Noemie Vulquin

Matthieu Bosset

Yoann Pointreau

Xavier Liem

Christian Sire

Ariane Lapierre

Sebastien Salas

Pierre Boisselier

Alexis Lenglet

Esma Saada-Bouzid

Valentin Calugaru

Florence Huguet

Camille Evrard

Sebastien Thureau

Francois Georges Riet

Frederic Rolland

Christian Borel

Xavier Tchiknavorian

Anouchka Modesto

Sophie Chapet

Yungan Tao

Tamta Makharadze

Eter Natelauri

Amiran Matitashvili

Miranda Gogishvili

Tamar Melkadze

Davit Giorgadze

Maike de Wit

Christine Langer

Rami El Shafie

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

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

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Docetaxel

Capecitabine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Gemcitabine, Docetaxel, Capecitabine:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11

This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.

Gemcitabine, Docetaxel, Capecitabine

Robert L Fine, MD

This study is designed to determine whether an investigational drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.

This Phase II multicenter study is designed to determine the response rate to a biochemically synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic pancreatic cancer. It will further determine the overall and one year survival rates, the diseasefree interval, and the toxicities for this regimen in patients with metastatic pancreatic cancer.

Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)

Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)

Data was not analyzed because original PI left institution before data analysis was completed.

Sanofi

Columbia University

AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).

Gemcitabine, Docetaxel, Capecitabine:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11

This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.

Gemzar, Taxotere, Xeloda

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11

This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)	NCT06056310	Head and Neck C...	Xevinapant Cisplatin intensity-modul...	18 Years -	EMD Serono
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)	NCT05386550	Head and Neck C...	Xevinapant (Deb... IMRT Placebo	18 Years -	EMD Serono
Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)	NCT00996333	Metastatic Panc...	Gemcitabine, Do...	18 Years - 70 Years	Columbia University
Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)	NCT00996333	Metastatic Panc...	Gemcitabine, Do...	18 Years - 70 Years	Columbia University
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)	NCT05386550	Head and Neck C...	Xevinapant (Deb... IMRT Placebo	18 Years -	EMD Serono
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)	NCT06056310	Head and Neck C...	Xevinapant Cisplatin intensity-modul...	18 Years -	EMD Serono

Spots Global Cancer Trial Database for stage ivb

Every month we try and update this database with for stage ivb cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for stage ivb

Every month we try and update this database with for stage ivb 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 stage ivb 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.