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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
Date last updated
12/09/2025
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
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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)
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Secondary ID [1]
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2024-512583-57-00
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Secondary ID [2]
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D702AC00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2-positive Gastric Cancer
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Gastroesophageal Junction Adenocarcinoma
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression free survival (PFS)
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Assessment method [1]
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PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
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Timepoint [1]
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Up to approximately 6 years
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as time from randomization until the date of death due to any cause.
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR according to RECIST v1.1. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).
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Timepoint [1]
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Up to approximately 6 years
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Secondary outcome [2]
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Duration of Response (DoR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [3]
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Proportion of all randomized participants alive and progression-free at 6 months (PFS6)
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Assessment method [3]
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Proportion of all randomized participants alive and progression-free at 6 months calculated for progression.
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Timepoint [3]
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Up to 6 months
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Secondary outcome [4]
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Proportion of all randomized participants alive and progression-free at 12 months (PFS12)
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Assessment method [4]
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Proportion of all randomized participants alive and progression-free at 12 months calculated for progression.
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Timepoint [4]
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Up to 12 months
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Secondary outcome [5]
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Time to second progression or death (PFS2)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to approximately 6 years
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Secondary outcome [6]
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Occurrence of adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [6]
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Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.
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Timepoint [6]
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Up to approximately 6 years
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Secondary outcome [7]
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Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
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Assessment method [7]
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Concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, fluoropyrimidine, and capecitabine in serum or plasma.
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Timepoint [7]
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Up to approximately 6 years
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Secondary outcome [8]
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Immunogenicity of rilvegostomig and T-DXd assessed by the presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd
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Assessment method [8]
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Presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
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Timepoint [8]
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Up to approximately 6 years
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Secondary outcome [9]
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Increase in enteral feeding assistance and eating difficulties
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Assessment method [9]
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Time to first-confirmed worsening of eating symptoms or initiation of feeding assistance among all participants, as randomized.
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Timepoint [9]
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Up to approximately 6 years
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Secondary outcome [10]
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Proportion of time on study intervention with high side-effect bother
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Assessment method [10]
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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).
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Timepoint [10]
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Up to approximately 6 years
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Secondary outcome [11]
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Overall Survival at 12 months (OS12)
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Assessment method [11]
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Proportion of all randomized participants alive at 12 months.
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Timepoint [11]
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Up to 12 months
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Secondary outcome [12]
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Overall Survival at 24 months (OS24)
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Assessment method [12]
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Proportion of all randomized participants alive at 24 months.
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Timepoint [12]
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Up to 24 months
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Secondary outcome [13]
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Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum
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Assessment method [13]
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PK parameters (peak and trough concentrations).
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Timepoint [13]
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Up to approximately 6 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/12/2030
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Actual
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Sample size
Target
840
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Darlinghurst
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Recruitment hospital [2]
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Research Site - Heidelberg
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Recruitment hospital [3]
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Research Site - Murdoch
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Recruitment hospital [4]
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Research Site - Westmead
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment outside Australia
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Ulm
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Torino
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Amsterdam
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Vinh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase ?, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS = 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.
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Trial website
https://clinicaltrials.gov/study/NCT06764875
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Public notes
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Contacts
Principal investigator
Name
0
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Phone
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1-877-240-9479
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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
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