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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06116136




Registration number
NCT06116136
Ethics application status
Date submitted
28/09/2023
Date registered
3/11/2023

Titles & IDs
Public title
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Scientific title
Open Label, Non-randomized, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of S095029 (Anti-NKG2A Antibody) as a Part of Combination Therapy in Participants With Locally Advanced and Unresectable or Metastatic MSI-H/dMMR Gastro-esophageal Junction /Gastric Cancer
Secondary ID [1] 0 0
Keynote E70
Secondary ID [2] 0 0
CL1-95029-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MSI-H/dMMR Gastroesophageal-junction Cancer 0 0
MSI-H/dMMR Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - S095029
Treatment: Drugs - pembrolizumab 200 mg (KEYTRUDA ®)

Experimental: S095029 and pembrolizumab - 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.


Treatment: Drugs: S095029
Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).

Treatment: Drugs: pembrolizumab 200 mg (KEYTRUDA ®)
Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Primary outcome [2] 0 0
Total Number of Adverse Events (AEs)
Timepoint [2] 0 0
From screening to 90 days after the last dose
Primary outcome [3] 0 0
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Timepoint [3] 0 0
From screening to 90 days after the last dose
Primary outcome [4] 0 0
Adverse Events (AEs) Leading to Dose Discontinuation
Timepoint [4] 0 0
From screening to 90 days after the last dose
Primary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Duration of Response (DoR)
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Trough Concentrations of S095029 (Ctrough)
Timepoint [5] 0 0
From first dose to 30 days after the last dose
Secondary outcome [6] 0 0
Concentration of potential antibodies directed against S095029
Timepoint [6] 0 0
From screening to 30 days after the last dose, or end of study if clinically indicated
Secondary outcome [7] 0 0
Objective Response Rate (ORR)
Timepoint [7] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
* Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
* Participants' tumor must have an MSI-H or dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has received more than one previous line of treatment in the locally advanced and unresectable or metastatic setting.
* Has received prior therapy with any checkpoint inhibitor (anti-PD-1, anti-programmed cell death ligand 1 (PDL1), anti-CTLA4).
* Participants who have received prior systemic anti-cancer therapy including investigational agents within 4 weeks (shorter interval, at least 5 half-lives, for kinase inhibitors or other short half-life drugs) prior to first study treatment.
* Prior radiotherapy if completed less than 2 weeks before first study treatment
* Major surgery less than 4 weeks prior to the first study treatment or participants who have not recovered from the side effects of the surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2029
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elisabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Hungary
State/province [2] 0 0
Gyöngyös
Country [3] 0 0
Spain
State/province [3] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Servier Bio-Innovation LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Institut de Recherches Internationales Servier
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Institut de Recherches Internationales Servier, Clinical Studies Department
Address 0 0
Country 0 0
Phone 0 0
+33 1 55 72 60 00
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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:

* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

* sponsored by Servier
* with a first patient enrolled as of 1 January 2004 onwards
* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
After Marketing Authorization in EEA or US if the study is used for the approval.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicaltrials.servier.com/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06116136