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| ID | Type | Description | Link |
|---|---|---|---|
| Keynote E70 | Other Identifier | Merck | |
| 2023-507995-33 | EudraCT Number | ||
| MK-3475-E70 | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Institut de Recherches Internationales Servier | OTHER |
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This study will investigate the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) in combination with pembrolizumab in in microsatellite instability-high/Defective mismatch repair (MSI-H/dMMR) locally advanced unresectable or metastatic gastric /GEJ adenocarcinomas.
This Phase 1b/2 study will be conducted in two parts; a safety lead-in part (Phase 1b) to identify the RP2D of S095029 in combination with pembrolizumab and an expansion part (Phase 2) to evaluate anti-tumor activity and safety in participants with locally advanced unresectable or metastatic MSI-H/dMMR gastric /GEJ adenocarcinomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S095029 and pembrolizumab | Experimental | Participants diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJ), not previously treated with checkpoint inhibitors (CPIs) may first be enrolled into a Phase 1b safety lead-in part which will be used to identify the recommended Phase 2 dose (RP2D) of S095029 in combination with pembrolizumab. During the Phase 2 part, participants will receive the recommended Phase 2 dose (RP2D) of S095029, along with pembrolizumab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S095029 | Drug | Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose-Limiting Toxicities (DLTs) | Phase 1b and Phase 2 | At the end of Cycle 1 (each cycle is 21 days) |
| Total Number of Adverse Events (AEs) | Phase 1b and Phase 2 | From screening to 90 days after the last dose |
| Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays | Phase 1b and Phase 2 | From screening to 90 days after the last dose |
| Adverse Events (AEs) Leading to Dose Discontinuation | Phase 1b and Phase 2 | From screening to 90 days after the last dose |
| Objective Response Rate (ORR) | Phase 2 ONLY. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | Phase 1b and Phase 2. The time from the first documentation of complete response (CR) or partial response (PR) until the documented progressive disease (PD) or death, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST). | Approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocala Oncology Center Pl | Ocala | Florida | 34474 | United States | ||
| Investigative Clinical Research of Indiana, Llc |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorization in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| pembrolizumab 200 mg (KEYTRUDA ®) | Drug | Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W). |
|
| Progression-Free Survival (PFS) |
Phase 1b and Phase 2. The time from the first dose of S095029 to first documented PD or death due to any cause, whichever occurs first, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST). |
| Approximately 2 years |
| Disease Control Rate (DCR) | Phase 1b and Phase 2. The proportion of participants who achieved stable disease (SD), PR, or CR (based on participant's best response), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST). | Approximately 2 years |
| Overall Survival (OS) | Phase 1b and Phase 2. The time from first S095029 dose to death due to any cause. | Approximately 2 years |
| Trough Concentrations of S095029 (Ctrough) | Phase 1b and Phase 2. | From first dose to 30 days after the last dose |
| Concentration of potential antibodies directed against S095029 | Phase 1b and Phase 2. | From screening to 30 days after the last dose, or end of study if clinically indicated |
| Objective Response Rate (ORR) | Phase 1b ONLY. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per immune Response Evaluation Criteria in Solid Tumors (iRECIST). | Approximately 2 years |
| Noblesville |
| Indiana |
| 46062 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| The Queen Elizabeth Hospital | Woodville South | 5011 | Australia |
| Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH) | Vienna | State of Vienna | 01090 | Austria |
| Ordensklinikum Linz | Linz | Upper Austria | 04010 | Austria |
| Landeskrankenhaus (SALK) | Salzburg | 5020 | Austria |
| UZ Leuven Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Chu de Liege | Liège | 4000 | Belgium |
| Cepon - Centro de Pesquisas Oncologicas | Florianópolis | 88034-000 | Brazil |
| Supera Oncologia | Santa Catarina | 89812-211 | Brazil |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | 01246-000 | Brazil |
| Instituto Brasileiro de Controle Do Câncer | São Paulo | 04014-002 | Brazil |
| Hospital Albert Einstein | São Paulo | 05652- 900 | Brazil |
| Mount Sinai Hospital | Toronto | M5G 1X5 | Canada |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| Liaoning Cancer Hospital | Shenyang | Liaoning | 110042 | China |
| Shandong Cancer Hospital Institute | Jinan | Shandong | 250117 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 201321 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch | Hangzhou | Zhengjiang Province | 310000 | China |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| Institut Bergonié | Bordeaux | 33076 | France |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Chru Lille - Hopital Claude Huriez | Lille | 59037 | France |
| Institut Curie | Saint-Cloud | 92064 | France |
| Inst. de Cancer de L'ouest | Saint-Herblain | 44805 | France |
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Semmelweis Egyetem | Budapest | 01083 | Hungary |
| Orszagos Onkologiai Intezet | Budapest | 01122 | Hungary |
| Bugat Pal Hospital | Gyöngyös | 3200 | Hungary |
| Bekes Megyei Kozponti Korhaz | Gyula | 05700 | Hungary |
| A.O.U. Seconda Università Degli Studi Di Napoli | Campania | 80131 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumor | Milan | 20133 | Italy |
| A.O.U. Pisana-Ospedale Santa Chiara | Pisa | 56126 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | 00168 | Italy |
| Policlinico G.B. Rossi A.O.U.I. Di Verona | Verona | 37134 | Italy |
| Cancer Institute Hospital of Jfcr | Koto-Ku | Tokyo | 1358550 | Japan |
| National Cancer Center Hospital | Chou-ku | 104-0045 | Japan |
| Osaka International Cancer Institute | Osaka | 5418567 | Japan |
| Pan American Center For Oncology Trials, Llc | Rio Piedras | 00935 | Puerto Rico |
| University Hospital Vall D'Hebron Institute of Oncology (VHIO) | Barcelona | 08035 | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario de Valencia | Valencia | 46010 | Spain |
| The Royal Marsden in Chelsea | London | SW3 6JJ | United Kingdom |
| The Royal Marsden in Sutton | Sutton, Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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