{"ctNumber":"2026-525620-23-00","ctStatus":"Authorised","decisionDate":"2026-07-22T10:55:01.733","publishDate":"2026-07-29T03:42:06.995509076","ctPublicStatusCode":2,"authorizedApplication":{"authorizedPartI":{"id":138665,"rowSubjectCount":12,"rowCountriesInfo":[{"eutctId":100000000432,"name":"Japan","isoNumber":392,"isoAlpha2Code":"JP","isoAlpha3Code":"JPN","current":true}],"products":[{"id":577936,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11254070","productPharmForm":"SOLUTION FOR INFUSION","euMpNumber":"PRD10448215","prodAuthStatus":1,"prodName":"Rilvegostomig","pharmForm":"SOLUTION FOR INFUSION","sponsorProductCode":"AZD2936","activeSubstanceName":"RILVEGOSTOMIG","euSubstNumber":"SUB295804","nameOrg":"ASTRAZENECA AB","productSubstances":[{"productPk":"11254070","substancePk":"339662","nameOrg":"ASTRAZENECA AB","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"RILVEGOSTOMIG","substanceEvCode":"SUB295804","synonyms":["AZD 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gástrico avanzado: el proyecto RILVE","language":7,"languageDescription":"Spanish"}],"shortTitle":"VHIO26001/ESR2523009","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"window-of-opportunity clinical study","trialCategoryId":128103},"medicalCondition":{"partIMedicalConditions":[{"id":145199,"medicalCondition":"advanced gastric cancer","medicalConditionTranslations":[{"id":11692952,"uuid":"ee8f2b6c-070c-4907-861d-7f3af3c09ac4","attributeTranslation":"cáncer gástrico avanzado","language":7,"languageDescription":"Spanish"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000016917,"version":"21.1","level":"PT","termName":"Gastric 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durante la fase de «ventana de oportunidad» y el tratamiento combinado posterior.","language":7,"languageDescription":"Spanish"}],"secondaryObjectives":[{"id":495200,"number":1,"secondaryObjective":"To assess anti-tumour activity of study drug in short- and long-term endpoints.","secondaryObjectiveTranslations":[{"id":11693001,"uuid":"1d62c492-84f3-4dc9-9727-c6ff19f7e80d","attributeTranslation":"Evaluar la actividad antitumoral del fármaco en estudio en los criterios de valoración a corto y largo plazo.","language":7,"languageDescription":"Spanish"}]},{"id":495201,"number":2,"secondaryObjective":"To study whether immunological changes (local and/or systemic) induced by rilvegostomig can serve as biomarkers of treatment response.","secondaryObjectiveTranslations":[{"id":11693002,"uuid":"720ee8af-a013-4889-ada0-ab18db1f9d80","attributeTranslation":"Estudiar si los cambios inmunológicos (locales y/o sistémicos) inducidos por el rilvegostomig pueden servir como biomarcadores de la respuesta al tratamiento.","language":7,"languageDescription":"Spanish"}]},{"id":495202,"number":3,"secondaryObjective":"To assess the safety and tolerability of rilvegostomig/pembrolizumab monotherapy and the safety and tolerability of rilvegostomig/pembrolizumab in combination with FOLFOX or CAPOX.","secondaryObjectiveTranslations":[{"id":11693003,"uuid":"e2740006-95ca-4330-a5fb-188921ef7730","attributeTranslation":"Evaluar la seguridad y la tolerabilidad de la monoterapia con rilvegostomig/pembrolizumab, así como la seguridad y la tolerabilidad de la combinación de rilvegostomig/pembrolizumab con FOLFOX o CAPOX.","language":7,"languageDescription":"Spanish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":943475,"number":1,"principalInclusionCriteria":"Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.","principalInclusionCriteriaTranslations":[{"id":11692984,"uuid":"91145005-e7eb-42bc-ab8c-e48bb621fdf8","attributeTranslation":"Capaz de dar su consentimiento informado y firmado, lo que implica el cumplimiento de los requisitos y restricciones que figuran en el formulario de consentimiento informado (FCI) y en este protocolo. Se deberá obtener del paciente o de su representante legal el consentimiento informado por escrito y cualquier autorización exigida a nivel local (por ejemplo, la Directiva sobre protección de datos de la Unión Europea [UE] en la UE) antes de realizar cualquier procedimiento relacionado con el protocolo, incluidas las evaluaciones de selección.","language":7,"languageDescription":"Spanish"}]},{"id":943476,"number":10,"principalInclusionCriteria":"At least one lesion amenable to biopsy must be present.","principalInclusionCriteriaTranslations":[{"id":11692985,"uuid":"f46b8858-49d8-4450-a4f0-927273f26aa0","attributeTranslation":"Debe haber al menos una lesión susceptible de ser sometida a biopsia.","language":7,"languageDescription":"Spanish"}]},{"id":943477,"number":11,"principalInclusionCriteria":"Adequate normal organ and marrow function, defined as: haemoglobin ≥ 9.0 g/dL (5.59 mmol/L) with no packed red blood cell transfusions within 14 days prior to the first dose; absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (1,500/mm³); platelet count ≥ 100 × 10⁹/L (100,000/mm³) with no platelet transfusions within 14 days prior to the first dose; serum bilirubin ≤ 1.5 × ULN in the absence of Gilbert’s syndrome, or ≤ 3 × ULN in patients with Gilbert’s syndrome; AST (SGOT) and ALT (SGPT) ≤ 3 × ULN, or ≤ 5 × ULN in case of liver metastasis; and measured creatinine clearance ≥ 45 mL/min or calculated creatinine clearance > 45 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection.","principalInclusionCriteriaTranslations":[{"id":11692986,"uuid":"762432da-ab20-48ee-81c9-9994c1dbc4ea","attributeTranslation":"Función normal y adecuada de los órganos y la médula ósea, definida como: hemoglobina ≥ 9,0 g/dl (5,59 mmol/l) sin transfusiones de concentrado de glóbulos rojos en los 14 días previos a la primera dosis; recuento absoluto de neutrófilos (RAN) ≥ 1,5 × 10⁹/l (1.500/mm³); recuento de plaquetas ≥ 100 × 10⁹/L (100 000/mm³) sin transfusiones de plaquetas en los 14 días previos a la primera dosis; bilirrubina sérica ≤ 1,5 × LSN en ausencia de síndrome de Gilbert, o ≤ 3 × LSN en pacientes con síndrome de Gilbert; AST (SGOT) y ALT (SGPT) ≤ 3 × LSN, o ≤ 5 × LSN en caso de metástasis hepáticas; y aclaramiento de creatinina medido ≥ 45 ml/min o aclaramiento de creatinina calculado > 45 ml/min mediante la fórmula de Cockcroft-Gault o mediante recogida de orina de 24 horas.","language":7,"languageDescription":"Spanish"}]},{"id":943478,"number":12,"principalInclusionCriteria":"Left ventricle ejection fraction (LVEF) ≥ 50% by echocardiogram or multi-gated acquisition (MUGA) scan (performed at screening; historical assessment within 3 months prior to first dose is acceptable if available).","principalInclusionCriteriaTranslations":[{"id":11692987,"uuid":"ddc4adeb-462a-43bb-bce7-db96c262fb97","attributeTranslation":"Fracción de eyección del ventrículo izquierdo (FEVI) ≥ 50 % según ecocardiograma o gammagrafía con adquisición multigated (MUGA) (realizada en la selección; se acepta una evaluación previa realizada en los tres meses anteriores a la primera dosis, si está disponible).","language":7,"languageDescription":"Spanish"}]},{"id":943479,"number":13,"principalInclusionCriteria":"Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.","principalInclusionCriteriaTranslations":[{"id":11692988,"uuid":"d997aca1-bb20-45d3-93a0-c7d583f43db1","attributeTranslation":"El paciente está dispuesto y es capaz de cumplir el protocolo durante toda la duración del estudio, lo que incluye someterse al tratamiento y acudir a las visitas y exploraciones programadas, incluido el seguimiento.","language":7,"languageDescription":"Spanish"}]},{"id":943480,"number":14,"principalInclusionCriteria":"Patient is willing to comply with reproduction and contraception guidance, consistent with local regulations regarding contraception methods for participants in clinical studies. Female patients of childbearing potential must have a negative pregnancy test at screening and prior to each administration of investigational product; if sexually active with a non-sterilized male partner, must use at least one highly effective method of contraception from screening until 60 days after the last dose of investigational product; must ensure that non-sterilized male partners use a male condom plus spermicide, or a male condom without spermicide if spermicide is not available, from screening until 60 days after the last dose of investigational product; must not breastfeed; and must not donate or retrieve ova for their own use from screening until 60 days after the last dose of investigational product. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide, or a male condom without spermicide if spermicide is not available, from screening until 60 days after the last dose of investigational product; their female partners of childbearing potential must use at least one highly effective method of contraception during this period; and male patients must refrain from fathering a child or donating sperm during the study and until 60 days after the last dose of investigational product. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.","principalInclusionCriteriaTranslations":[{"id":11692989,"uuid":"edc53005-6767-46e7-a3ed-2e5da0882306","attributeTranslation":"El paciente está dispuesto a cumplir con las recomendaciones sobre reproducción y anticoncepción, de acuerdo con la normativa local relativa a los métodos anticonceptivos para participantes en estudios clínicos. Las pacientes mujeres con capacidad reproductiva deben tener una prueba de embarazo negativa en la selección y antes de cada administración del medicamento en investigación; si son sexualmente activas con una pareja masculina no esterilizada, deben utilizar al menos un método anticonceptivo altamente eficaz desde la selección hasta 60 días después de la última dosis del medicamento en investigación; deben asegurarse de que sus parejas masculinas no esterilizadas utilicen preservativo masculino con espermicida, o preservativo masculino sin espermicida si este no está disponible, desde la selección hasta 60 días después de la última dosis del medicamento en investigación; no deben dar el pecho; y no deben donar ni extraer óvulos para uso propio desde la selección hasta 60 días después de la última dosis del medicamento en investigación. Los pacientes varones no esterilizados que sean sexualmente activos con una pareja femenina con capacidad reproductiva deben utilizar preservativo masculino con espermicida, o preservativo masculino sin espermicida si este no está disponible, desde la selección hasta 60 días después de la última dosis del medicamento en investigación; sus parejas femeninas con capacidad reproductiva deben utilizar al menos un método anticonceptivo altamente eficaz durante este periodo; y los pacientes varones deben abstenerse de engendrar un hijo o donar esperma durante el estudio y hasta 60 días después de la última dosis del medicamento en investigación. La abstinencia periódica, el método del ritmo y el coito interrumpido no son métodos anticonceptivos aceptables.","language":7,"languageDescription":"Spanish"}]},{"id":943481,"number":15,"principalInclusionCriteria":"As judged by investigator, there are no contradictions for FOLFOX or CAPOX.","principalInclusionCriteriaTranslations":[{"id":11692990,"uuid":"f3a6243d-df9d-47f8-817c-d4bb104167f1","attributeTranslation":"Según el criterio del investigador, no hay contradicciones en el caso de FOLFOX ni de CAPOX.","language":7,"languageDescription":"Spanish"}]},{"id":943482,"number":2,"principalInclusionCriteria":"Age > 18 years at time of study entry.","principalInclusionCriteriaTranslations":[{"id":11692991,"uuid":"bf983242-6e03-4358-ba7b-a176904615f4","attributeTranslation":"Edad > 18 años en el momento de la inclusión en el estudio.","language":7,"languageDescription":"Spanish"}]},{"id":943483,"number":3,"principalInclusionCriteria":"Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.","principalInclusionCriteriaTranslations":[{"id":11692992,"uuid":"1422e21a-f69d-492d-92cf-362514ec2a4e","attributeTranslation":"Índice de rendimiento del Grupo Cooperativo Oncológico del Este (ECOG) de 0 o 1.","language":7,"languageDescription":"Spanish"}]},{"id":943484,"number":4,"principalInclusionCriteria":"Body weight >30 kg.","principalInclusionCriteriaTranslations":[{"id":11692993,"uuid":"80f8d896-4f01-45c6-9425-8fc0682e911f","attributeTranslation":"Peso corporal >30 kg.","language":7,"languageDescription":"Spanish"}]},{"id":943485,"number":5,"principalInclusionCriteria":"Histologically confirmed gastric or gastroesophageal junction adenocarcinoma.","principalInclusionCriteriaTranslations":[{"id":11692994,"uuid":"56e8da60-6ae5-451e-b427-9a5db99d2c20","attributeTranslation":"Adenocarcinoma gástrico o de la unión gastroesofágica confirmado histológicamente.","language":7,"languageDescription":"Spanish"}]},{"id":943486,"number":6,"principalInclusionCriteria":"Unresectable or metastatic gastric cancer or gastroesophageal junction with no previous systemic therapy for advanced disease.","principalInclusionCriteriaTranslations":[{"id":11692995,"uuid":"87e014d6-1618-4d8c-814f-cd228cc83ee4","attributeTranslation":"Cáncer gástrico o de la unión gastroesofágica irresecable o metastásico, sin tratamiento sistémico previo para la enfermedad avanzada.","language":7,"languageDescription":"Spanish"}]},{"id":943487,"number":7,"principalInclusionCriteria":"IHC of PD-L1 CPS>=1 and HER2-negative.","principalInclusionCriteriaTranslations":[{"id":11692996,"uuid":"1ae40038-f46c-463e-86de-20fbb21160f1","attributeTranslation":"Inmunohistoquímica de PD-L1 con número de puntos por campo (CPS) ≥ 1 y HER2 negativo.","language":7,"languageDescription":"Spanish"}]},{"id":943488,"number":8,"principalInclusionCriteria":"Prior curative intent treatment (surgery and, if given in the adjuvant setting, chemotherapy and/or radiation) is permitted, regardless of time to recurrence, provided that no prior immunotherapy was administered in the curative or perioperative setting.","principalInclusionCriteriaTranslations":[{"id":11692997,"uuid":"080dadfc-f6a7-43be-8be1-01d03b27633e","attributeTranslation":"Se permite el tratamiento previo con intención curativa (cirugía y, si se administró en el contexto adyuvante, quimioterapia y/o radioterapia), independientemente del tiempo transcurrido hasta la recidiva, siempre que no se haya administrado previamente inmunoterapia en el contexto curativo o perioperatorio.","language":7,"languageDescription":"Spanish"}]},{"id":943489,"number":9,"principalInclusionCriteria":"At least one lesion that qualifies as a RECIST 1.1 measurable target lesion at baseline. However, patients without measurable lesions, but with evaluable disease, would be accepted (e.g.; those patients with advanced disease with peritoneal metastasis).","principalInclusionCriteriaTranslations":[{"id":11692998,"uuid":"d2138f1d-74ad-47ab-bb45-4caf214fa8bd","attributeTranslation":"Al menos una lesión que cumpla los criterios de RECIST 1.1 como lesión diana medible en el momento de la inclusión. No obstante, se aceptarán pacientes sin lesiones medibles, pero con enfermedad evaluable (por ejemplo, aquellos pacientes con enfermedad avanzada y metástasis peritoneales).","language":7,"languageDescription":"Spanish"}]}],"principalExclusionCriteria":[{"id":1612166,"number":1,"principalExclusionCriteria":"Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study","principalExclusionCriteriaTranslations":[{"id":11692963,"uuid":"97834057-1d78-4d06-a8c4-475489b17d53","attributeTranslation":"Participación simultánea en otro estudio clínico, salvo que se trate de un estudio clínico observacional (no intervencionista) o que tenga lugar durante el periodo de seguimiento de un estudio intervencional","language":7,"languageDescription":"Spanish"}]},{"id":1612167,"number":10,"principalExclusionCriteria":"History of organ transplant or allogenic stem cell transplant.","principalExclusionCriteriaTranslations":[{"id":11692964,"uuid":"f419581a-2b6e-44af-829b-e6bbadfac99a","attributeTranslation":"Antecedentes de trasplante de órgano o de trasplante alogénico de células madre.","language":7,"languageDescription":"Spanish"}]},{"id":1612168,"number":11,"principalExclusionCriteria":"Active or prior documented autoimmune disorders or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs. Patients receiving replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) can be enrolled at the discretion of the investigator.","principalExclusionCriteriaTranslations":[{"id":11692965,"uuid":"9963e7c8-87ee-4e31-a20b-7761b9b996c2","attributeTranslation":"Trastornos autoinmunes o inflamatorios activos o documentados anteriormente que requieran un tratamiento sistémico crónico con el uso de fármacos modificadores de la enfermedad, corticosteroides o fármacos inmunosupresores. Los pacientes que reciban terapia de sustitución (por ejemplo, tiroxina, insulina o terapia de sustitución con corticosteroides fisiológicos para la insuficiencia suprarrenal o hipofisaria) podrán ser incluidos a criterio del investigador.","language":7,"languageDescription":"Spanish"}]},{"id":1612169,"number":12,"principalExclusionCriteria":"History of another primary malignancy, except for malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy or adequately treated carcinoma in situ without evidence of disease.","principalExclusionCriteriaTranslations":[{"id":11692966,"uuid":"6bf6b347-b7f6-4d13-9e85-3b8f0bfecb59","attributeTranslation":"Antecedentes de otro tumor maligno primario, salvo en el caso de tumores tratados con intención curativa y sin enfermedad activa conocida desde hace al menos tres años antes de la primera dosis de la intervención del estudio, y con bajo riesgo potencial de recidiva; carcinoma basocelular de la piel, carcinoma espinocelular de la piel o lentigo maligno que haya sido sometido a un tratamiento potencialmente curativo, o carcinoma in situ tratado adecuadamente sin signos de enfermedad.","language":7,"languageDescription":"Spanish"}]},{"id":1612170,"number":13,"principalExclusionCriteria":"History of leptomeningeal carcinomatosis or central nervous metastases.","principalExclusionCriteriaTranslations":[{"id":11692967,"uuid":"de485185-5554-414d-90d8-118b0b72fa06","attributeTranslation":"Antecedentes de carcinomatosis leptomeníngea o metástasis en el sistema nervioso central.","language":7,"languageDescription":"Spanish"}]},{"id":1612171,"number":14,"principalExclusionCriteria":"History of active primary immunodeficiency.","principalExclusionCriteriaTranslations":[{"id":11692968,"uuid":"f820f336-7bbb-4391-b04c-70768f9e8c88","attributeTranslation":"Antecedentes de inmunodeficiencia primaria activa.","language":7,"languageDescription":"Spanish"}]},{"id":1612172,"number":15,"principalExclusionCriteria":"Known to have tested positive for HIV or active tuberculosis infection.","principalExclusionCriteriaTranslations":[{"id":11692969,"uuid":"6ed287af-1821-48c9-91fe-40f230343001","attributeTranslation":"Se sabe que ha dado positivo en las pruebas del VIH o que padece una infección activa de tuberculosis.","language":7,"languageDescription":"Spanish"}]},{"id":1612173,"number":16,"principalExclusionCriteria":"Evidence of any of the following infections: hepatitis B infection with anti-HBc IgM positivity and/or HBV DNA ≥ 2000 IU/mL; patients with hepatitis B infection who are anti-HBc total positive and have HBV DNA < 2000 IU/mL may be included provided they receive antiviral prophylaxis and are managed for their HBV status as described in the protocol. Active hepatitis C infection, defined as anti-HCV positivity with detectable HCV RNA, or anti-HCV positivity with undetectable HCV RNA less than 12 weeks after treatment for HCV; patients who are anti-HCV positive with undetectable HCV RNA for at least 12 weeks, either due to successful treatment or spontaneous clearance of HCV infection, are eligible and do not require periodic HCV RNA testing during the study unless clinically indicated.","principalExclusionCriteriaTranslations":[{"id":11692970,"uuid":"351fcb20-1b2b-4dd3-af12-49399edf5f63","attributeTranslation":"Indicios de cualquiera de las siguientes infecciones: infección por hepatitis B con positividad para IgM anti-HBc y/o ADN del VHB ≥ 2000 UI/ml; los pacientes con infección por hepatitis B que sean positivos para anti-HBc total y tengan un ADN del VHB < 2000 UI/ml podrán ser incluidos siempre que reciban profilaxis antiviral y sean tratados según su estado de VHB tal y como se describe en el protocolo. Infección activa por hepatitis C, definida como positividad para anti-HCV con ARN del VHC detectable, o positividad para anti-HCV con ARN del VHC indetectable menos de 12 semanas después del tratamiento contra el VHC; los pacientes que sean anti-VHC positivos con ARN del VHC indetectable durante al menos 12 semanas, ya sea debido al éxito del tratamiento o a la eliminación espontánea de la infección por el VHC, son elegibles y no requieren pruebas periódicas de ARN del VHC durante el estudio, a menos que esté clínicamente indicado.","language":7,"languageDescription":"Spanish"}]},{"id":1612174,"number":17,"principalExclusionCriteria":"Any other active or uncontrolled infection requiring systemic treatment that has not resolved by the time of study assignment.","principalExclusionCriteriaTranslations":[{"id":11692971,"uuid":"e848add3-6ef2-4577-9c58-9ef9c379d4a6","attributeTranslation":"Cualquier otra infección activa o no controlada que requiera tratamiento sistémico y que no se haya resuelto en el momento de la asignación al estudio.","language":7,"languageDescription":"Spanish"}]},{"id":1612175,"number":18,"principalExclusionCriteria":"Any of the following cardiac conditions, as determined by the investigator: symptomatic or treatment-requiring complex ventricular arrhythmia, such as multifocal premature ventricular contractions, bigeminy, trigeminy or ventricular tachycardia, corresponding to CTCAE Grade 3; symptomatic heart failure defined as New York Heart Association class ≥ 3; cardiomyopathy of any etiology or history of myocarditis; myocardial infarction or unstable angina within the past 6 months; uncontrolled hypertension; mean resting corrected QT interval > 470 ms, obtained from triplicate ECGs performed at screening; history of QT prolongation associated with other medications requiring discontinuation of that medication; congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives; history of symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted based on the investigator’s judgement, with cardiologist consultation recommended. 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