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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06764875




Registration number
NCT06764875
Ethics application status
Date submitted
12/12/2024
Date registered
9/01/2025

Titles & IDs
Public title
A Phase ? Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
Scientific title
A Randomized, Phase ? Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)
Secondary ID [1] 0 0
2024-512583-57-00
Secondary ID [2] 0 0
D702AC00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2-positive Gastric Cancer 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rilvegostomig
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - 5-fluorouracil
Treatment: Drugs - Capecitabine
Treatment: Drugs - Cisplatin
Treatment: Drugs - Oxaliplatin

Experimental: Arm A - T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)

Active comparator: Arm B - Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)

Active comparator: Arm C - Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)


Treatment: Drugs: Rilvegostomig
Q3W, intravenous infusion

Treatment: Drugs: Trastuzumab deruxtecan
Q3W, intravenous infusion

Treatment: Drugs: Trastuzumab
Q3W, intravenous infusion

Treatment: Drugs: Pembrolizumab
Q3W, intravenous infusion

Treatment: Drugs: 5-fluorouracil
Q3W, intravenous infusion

Treatment: Drugs: Capecitabine
BID, oral administration

Treatment: Drugs: Cisplatin
Q3W, intravenous infusion

Treatment: Drugs: Oxaliplatin
Q3W, intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS)
Assessment method [1] 0 0
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Timepoint [1] 0 0
Up to approximately 6 years
Primary outcome [2] 0 0
Overall Survival (OS)
Assessment method [2] 0 0
OS is defined as time from randomization until the date of death due to any cause.
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Assessment method [1] 0 0
ORR according to RECIST v1.1. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
Duration of Response (DoR)
Assessment method [2] 0 0
DoR according to RECIST v1.1. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 or death due to any cause.
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [3] 0 0
Proportion of all randomized participants alive and progression-free at 6 months (PFS6)
Assessment method [3] 0 0
Proportion of all randomized participants alive and progression-free at 6 months calculated for progression.
Timepoint [3] 0 0
Up to 6 months
Secondary outcome [4] 0 0
Proportion of all randomized participants alive and progression-free at 12 months (PFS12)
Assessment method [4] 0 0
Proportion of all randomized participants alive and progression-free at 12 months calculated for progression.
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Time to second progression or death (PFS2)
Assessment method [5] 0 0
PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial progression), after the first subsequent therapy, or death, where the first objective progression includes progression occurring after 2 missed visits.
Timepoint [5] 0 0
Up to approximately 6 years
Secondary outcome [6] 0 0
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Assessment method [6] 0 0
Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.
Timepoint [6] 0 0
Up to approximately 6 years
Secondary outcome [7] 0 0
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
Assessment method [7] 0 0
Concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, fluoropyrimidine, and capecitabine in serum or plasma.
Timepoint [7] 0 0
Up to approximately 6 years
Secondary outcome [8] 0 0
Immunogenicity of rilvegostomig and T-DXd assessed by the presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd
Assessment method [8] 0 0
Presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
Timepoint [8] 0 0
Up to approximately 6 years
Secondary outcome [9] 0 0
Increase in enteral feeding assistance and eating difficulties
Assessment method [9] 0 0
Time to first-confirmed worsening of eating symptoms or initiation of feeding assistance among all participants, as randomized.
Timepoint [9] 0 0
Up to approximately 6 years
Secondary outcome [10] 0 0
Proportion of time on study intervention with high side-effect bother
Assessment method [10] 0 0
Proportion of time on study intervention with high side-effect bother relative to low side-effect burden as measured by the Patient Global Impression of Treatment Tolerability (PGI-TT).
Timepoint [10] 0 0
Up to approximately 6 years
Secondary outcome [11] 0 0
Overall Survival at 12 months (OS12)
Assessment method [11] 0 0
Proportion of all randomized participants alive at 12 months.
Timepoint [11] 0 0
Up to 12 months
Secondary outcome [12] 0 0
Overall Survival at 24 months (OS24)
Assessment method [12] 0 0
Proportion of all randomized participants alive at 24 months.
Timepoint [12] 0 0
Up to 24 months
Secondary outcome [13] 0 0
Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
Assessment method [13] 0 0
PK parameters (peak and trough concentrations).
Timepoint [13] 0 0
Up to approximately 6 years

Eligibility
Key inclusion criteria
* HER2 positive for gastric cancer on a tumor biopsy.
* PD-L1 combined positive score (CPS) = 1.
* Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
* Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.
* WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
* Have measurable target disease assessed by the Investigator based on RECIST v1.1.
* Have adequate organ and bone marrow function within 14 days before randomization.
* LVEF = 55% within 28 days before randomization.
* Adequate treatment washout period before randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Lack of physiological integrity of the upper gastrointestinal tract.
* Known dihydropyrimidine dehydrogenase enzyme deficiency.
* Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.
* Persistent toxicities caused by previous anti-cancer therapy.
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
* Uncontrolled infection including tuberculosis and active hepatitis A infection.
* Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
* Recent receipt of live, attenuated vaccine.
* Chronic/active HBV or HCV infection unless controlled.
* Clinically significant cardiac or psychological conditions.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Lung-specific intercurrent clinically significant illnesses.
* Any active non-infectious skin disease requiring systemic treatment.
* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
* History of any of the following: drug-induced severe cutaneous adverse reaction.
* Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
* Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
* Current or prior use of immunosuppressive medication within 14 days before study intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/11/2030
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Murdoch
Recruitment hospital [4] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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Georgia
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United States of America
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Illinois
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Indiana
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Kentucky
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Massachusetts
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Wisconsin
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Viedma
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Country [172] 0 0
Turkey
State/province [172] 0 0
Izmir
Country [173] 0 0
Turkey
State/province [173] 0 0
Mezitli
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Cambridge
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Coventry
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Dundee
Country [177] 0 0
United Kingdom
State/province [177] 0 0
London
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Manchester
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Sutton
Country [180] 0 0
Vietnam
State/province [180] 0 0
Hanoi
Country [181] 0 0
Vietnam
State/province [181] 0 0
Ho Chi Minh city
Country [182] 0 0
Vietnam
State/province [182] 0 0
Vinh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement


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/NCT06764875