← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2026-525620-23-00

Local and Systemic Immune Modulation by Rilvegostomig in Advanced Gastric Cancer: The RILVE Project

Public registry stateAuthorised

CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation

REGISTRY FACTS

What CTIS publishes about this trial

EUCT number: 2026-525620-23-00
Trial status: Authorised
Sponsor: not published
Trial region: Both
Phase: 4
Trial category: 2
Low-intervention trial: no
Estimated EU start: 01 June 2026
Decision date: 22 July 2026
Published: 23 July 2026
Estimated end: 01 June 2030

EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“…expression and/or spatial distribution in the tumor microenvironment (eg, CD8, PD-L1, etc.) as measured by IHC and other assays including analytical methods (eg, digital pathology artificial intelligence).”

Source field: authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[4].endPoint
Matched term: artificial intelligence

MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

advanced gastric cancer

Therapeutic areas

Diseases [C] - Digestive System Diseases [C06]6
Diseases [C] - Neoplasms [C04]4

COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Spain

Authorised

First decision: 22 July 2026
Latest decision: 22 July 2026

22 July 2026Authorised
22 July 2026Authorised

TRIAL APPLICATIONS

Submission, decision and country state remain separate

INITIAL

Authorised

Trial status: Authorised
Submitted: 30 April 2026
Decided: 22 July 2026

Decisions22 July 2026 · Authorized

Country statusSpain · Authorised

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

30 April 2026Application Submitted
Application IN · Authorised
20 July 2026Country Assessment
Spain · Application IN · Authorized
22 July 2026Application Status
Application IN · Authorised
22 July 2026Country Decision
Spain · Application IN · Authorized
23 July 2026Trial Status Observed
Authorised

Observed by i6eal

First observed: 23 Jul 2026, 13:19
Last observed: 23 Jul 2026, 15:03
Materially modified: 23 July 2026

RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓

i6eal (2026): EU AI Studies Monitor, CTIS trial 2026-525620-23-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2026-525620-23-00/