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Local and Systemic Immune Modulation by Rilvegostomig in Advanced Gastric Cancer: The RILVE Project
EU CTIS ID: 2026-525620-23-00
What this study is testing
To comprehensively characterize and quantify the local and systemic immunological effects induced by rilvegostomig in patients with treatment-naïve, advanced gastric cancer (GC), and to define the biological consequences of dual PD-1/TIGIT blockade during the window-of-opportunity phase and subsequent combination treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- At least one lesion amenable to biopsy must be present.
- 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.
- 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).
- 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.
- 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.
You likely can't join if
- 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
- History of organ transplant or allogenic stem cell transplant.
- 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.
- 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.
- History of leptomeningeal carcinomatosis or central nervous metastases.
- History of active primary immunodeficiency.
See the full eligibility criteria
Who can join
- 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.
- At least one lesion amenable to biopsy must be present.
- 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.
- 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).
- 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.
- 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.
- As judged by investigator, there are no contradictions for FOLFOX or CAPOX.
- Age > 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Body weight >30 kg.
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Unresectable or metastatic gastric cancer or gastroesophageal junction with no previous systemic therapy for advanced disease.
- IHC of PD-L1 CPS>=1 and HER2-negative.
- 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.
- 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).
What rules you out
- 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
- History of organ transplant or allogenic stem cell transplant.
- 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.
- 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.
- History of leptomeningeal carcinomatosis or central nervous metastases.
- History of active primary immunodeficiency.
- Known to have tested positive for HIV or active tuberculosis infection.
- 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.
- Any other active or uncontrolled infection requiring systemic treatment that has not resolved by the time of study assignment.
- 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. Left ventricular ejection fraction (LVEF) < 50% by echocardiogram or MUGA at screening.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Non-adenocarcinoma histological subtypes.
- Pregnant or breastfeeding or intend to become pregnant during the study.
- Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhoea, active primary immunodeficiency, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
- Any severe or uncontrolled systemic diseases which, in the investigator’s opinion, makes it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol, including psychiatric illness/social situations and substance abuse.
- Any unresolved NCI CTCAE Grade ≥ 2 toxicity from previous anticancer therapy, except for alopecia, vitiligo, and laboratory values defined in the inclusion criteria. Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by treatment with rilvegostomig may be included only after consultation with the Study Physician.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Palliative radiotherapy with a limited field of radiation within 3 weeks of the first dose of study intervention.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of treatment. Intranasal, inhaled, or topical steroids and doses below 10mg/24h or prednisone are allowed.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.