A Phase 2 interventional study of Rilvegostomig and Pembrolizumab in Advanced Gastric Cancer, sponsored by Vall d'Hebron Institute of Oncology. Not yet recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Vall d'Hebron Institute of Oncology · Phase 2, Interventional, and Treatment
Among 173 studies in Stomach Neoplasms with a site in Spain — 37 open to participants now, 63 under way, 12 of them phase 3. Stomach Neoplasms · Spain.
Among the 173 studies in Stomach Neoplasms with a site in Spain, this one is the 124th largest by planned enrollment of the 148 interventional ones that give a count, is one of 9 that started in 2026, is one of 42 in phase 2, reaches primary completion later than 54 of the 62 other live ones, and was the 171st registered.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
Browse Stomach Neoplasms studies →37 of the 173 studies in Stomach Neoplasms with a site in Spain are open now. Recruiting first, the newest first:
Pfizer · Sites in Spain, United States, Canada and 7 more countries
Ages 18+
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Spain, Netherlands, Norway
Ages 18+
Vall d'Hebron Institute of Oncology · Sites in Spain
Ages 18+
Bristol-Myers Squibb · Sites in Spain, United States, Argentina and 17 more countries
Ages 18+
EMD Serono Research & Development Institute, Inc. · Sites in Spain, United States, Canada and 1 more country
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 702 Stomach Neoplasms studies recruiting now, 375 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
173 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 64 · Phase 2 70 · Phase 3 34 · Phase 4 2
First in 2001; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Median enrollment 174 across the 148 interventional studies, 505 across the 25 observational. Of the 97 that completed or were terminated, 44 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
132 of 173 have an industry lead sponsor. The 10 most frequent:
Vall d'Hebron Institute of Oncology is the lead sponsor of 21 studies on the registry; 13 are open to participants now.
Vall d'Hebron Institute of Oncology has 3 studies filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
19 of the studies in Stomach Neoplasms with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01924819Phase 3Australasian Gastro-Intestinal Trials GroupTrial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma | 2026-12-31 |
| NCT06532006Phase 3Shanghai Henlius BiotechA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | 2027-06-01 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
| NCT05789069HiFiBiO TherapeuticsA Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors | 2026-12 |
| NCT05238883HiFiBiO TherapeuticsA Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors | 2026-12 |
Add all 19 to your calendar (.ics) → With an account.
Among the 173 studies in Stomach Neoplasms with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a multicenter, randomized Phase II window-of-opportunity study evaluating rilvegostomig (AZD2936) in patients with treatment-naïve, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1.
Rilvegostomig is a humanized bispecific monoclonal antibody that concurrently targets PD-1 and TIGIT, two immune checkpoint pathways involved in tumor immune suppression. The study is designed to characterize and quantify the local and systemic immunological effects induced by rilvegostomig and to define the biological consequences of dual PD-1/TIGIT blockade during an initial window-of-opportunity phase and subsequent combination treatment.
Approximately 50 participants will be randomized to receive either rilvegostomig or pembrolizumab. During the window-of-opportunity phase, participants will receive one cycle of immunotherapy monotherapy. Participants in the experimental arm will receive rilvegostomig 750 mg intravenously on Day 1 of a 21-day cycle. Participants in the control arm will receive pembrolizumab 200 mg intravenously on Day 1 of a 21-day cycle.
After the window-of-opportunity phase, participants will continue the assigned immunotherapy in combination with standard-of-care first-line chemotherapy, consisting of either FOLFOX administered every 2 weeks or CAPOX administered every 3 weeks, according to investigator choice and institutional practice. Combination treatment will be administered for up to approximately 8 cycles based on the every-3-week immunotherapy schedule, or until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. After completion of combination treatment, participants may continue maintenance therapy with a fluoropyrimidine, either capecitabine or 5-fluorouracil with leucovorin, plus the assigned immunotherapy for up to 24 months from the first immunotherapy dose.
The primary objective is to assess changes from baseline to the post-window-of-opportunity biopsy in predefined tumor and peripheral immune biomarkers reflecting immune cell infiltration, activation, and functional modulation induced by rilvegostomig. Tumor tissue and peripheral blood samples will be collected at predefined time points to evaluate local and systemic immune changes, immune cell composition, immune activation markers, immune function, and exploratory biomarkers associated with treatment response.
Secondary objectives include assessment of antitumor activity, evaluation of whether immunological changes may serve as biomarkers of treatment response, and characterization of the safety and tolerability of rilvegostomig or pembrolizumab as monotherapy and in combination with FOLFOX or CAPOX. Antitumor activity will be evaluated by radiologic tumor assessments using CT or MRI according to RECIST version 1.1, including objective response rate and progression-free survival. Safety will be monitored throughout the study by assessment of adverse events, serious adverse events, immune-mediated adverse events, dose-limiting toxicities, physical examinations, vital signs, ECOG performance status, clinical laboratory evaluations, and other clinically indicated assessments.
The study aims to determine whether rilvegostomig induces a distinct immune modulation profile compared with PD-1 inhibition alone and to support the identification of immune and molecular biomarkers that may inform future therapeutic strategies in advanced gastric cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate normal organ and marrow function as defined below:
Patient is willing to comply with the following Reproduction and guidance:
Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to Contraception Guidance for definitions of women of and highly effective methods of contraception.
Female patients of childbearing potential:
Non-sterilized male patients who are sexually active with a female partner of childbearing potential:
Exclusion Criteria:
Any unresolved toxicity Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Evidence of any of the following infections:
Patients who are anti-HCV positive with HCV RNA undetectable for least 12 weeks, either due to successful treatment, or spontaneous clearance of HCV infection, are eligible. These patients do not need periodic testing of HCV RNA on study, unless clinically indicated.
Any of the following cardiac conditions as determined by the investigator:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the experimental arm will receive rilvegostomig by intravenous infusion. During the window-of-opportunity phase, participants will receive one cycle of rilvegostomig monotherapy at 750 mg on Day 1 of a 21-day cycle. Thereafter, rilvegostomig 750 mg will be administered every 3 weeks in combination with standard-of-care first-line chemotherapy, consisting of either FOLFOX every 2 weeks or CAPOX every 3 weeks, according to investigator choice. Combination treatment will continue for up to approximately 8 cycles based on the every-3-week immunotherapy schedule, or until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. After completion of combination therapy, participants may continue maintenance treatment with rilvegostomig plus a fluoropyrimidine for up to 24 months from the first immunotherapy dose.
Biological: Rilvegostomig
Participants randomized to the control arm will receive pembrolizumab by intravenous infusion. During the window-of-opportunity phase, participants will receive one cycle of pembrolizumab monotherapy at 200 mg on Day 1 of a 21-day cycle. Thereafter, pembrolizumab 200 mg will be administered every 3 weeks in combination with standard-of-care first-line chemotherapy, consisting of either FOLFOX every 2 weeks or CAPOX every 3 weeks, according to investigator choice. Combination treatment will continue for up to approximately 8 cycles based on the every-3-week immunotherapy schedule, or until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. After completion of combination therapy, participants may continue maintenance treatment with pembrolizumab plus a fluoropyrimidine for up to 24 months from the first immunotherapy dose.
Biological: Pembrolizumab
Rilvegostomig is a humanized bispecific monoclonal antibody that concurrently targets PD-1 and TIGIT, modulating complementary immune checkpoint pathways to enhance T-cell and natural killer cell-mediated antitumor immune responses. In this study, rilvegostomig is administered intravenously at 750 mg every 3 weeks, initially as monotherapy during a window-of-opportunity cycle and subsequently in combination with standard-of-care chemotherapy, followed by possible maintenance treatment with a fluoropyrimidine.
Also known as: AZD2936
Pembrolizumab is a humanized monoclonal antibody that selectively inhibits PD-1 signaling, resulting in enhanced antigen-specific T-cell activation. In this study, pembrolizumab is used as the reference therapy and will be administered by intravenous infusion at an approved dose of 200 mg every 3 weeks. Participants will receive one cycle of pembrolizumab monotherapy during the window-of-opportunity phase, followed by pembrolizumab in combination with standard-of-care first-line chemotherapy consisting of either FOLFOX or CAPOX. After completion of combination treatment, pembrolizumab may be continued with fluoropyrimidine maintenance therapy for up to 24 months from the first immunotherapy dose.
Also known as: Keytruda
Change From Baseline in Tumor and Peripheral Immune Biomarkers After Window-of-Opportunity Treatment
This outcome will assess the change from baseline to the post-window-of-opportunity biopsy in predefined tumor and peripheral immune biomarkers reflecting immune cell infiltration, immune cell activation, and functional modulation induced by rilvegostomig in patients with treatment-naïve, advanced gastric cancer. Analyses will use paired tumor tissue and peripheral blood samples collected at predefined time points to characterize local and systemic immunological effects, including changes in immune cell composition, immune activation markers, immune function, and exploratory biomarkers associated with treatment response. The outcome is intended to define the biological consequences of dual PD-1/TIGIT blockade during the window-of-opportunity phase.
Time frame: Baseline to Cycle 2 Day 1 (each cycle is 21 days), prior to study treatment dosing on Cycle 2 Day 1.
Progression-free survival (PFS).
PFS is defined as the time from randomization until radiological progression (per Response Evaluation Criteria in Solid Tumors, Version 1.1 \[RECIST 1.1\]) or death due to any cause (in the absence of progression).
Time frame: From randomization until radiological disease progression per RECIST 1.1 or death due to any cause, whichever occurs first; assessed by CT/MRI every 8 weeks (±7 days) during treatment and thereafter as applicable until progression; up to 4 years
Overall response rate (ORR).
ORR is defined as the proportion of patients who have a confirmed complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Time frame: Baseline and every 8 weeks (±7 days) during treatment; CR/PR confirmed at least 4 weeks later. If treatment stops without progression, imaging continues until progression, new anticancer therapy, withdrawal of consent, or death.
Changes in Immune and Tumor Marker Profiles
This outcome will assess the presence of, or changes in, phenotype or expression of predefined immune and tumor markers or profiles in tumor tissue and peripheral blood samples. Analyses may include activated T cells, immune cell receptor repertoires, HLA allotypes, IFN-γ, CD8, tumor-infiltrating lymphocytes, and other immune or tumor microenvironment markers. The assessment is intended to characterize local and systemic immunological changes associated with rilvegostomig treatment and to explore whether these markers may serve as biomarkers of treatment response.
Time frame: Tumor tissue: baseline and Cycle 2 Day 1. Blood: Cycle 1 Day 1 (baseline), Cycle 1 Day 8, and Day 1 of Cycles 2, 3, 5, 7, and 9. Study cycles for biomarker assessments are 21 days (Q3W immunotherapy schedule).
Changes in ctDNA Mutation Profile
This outcome will assess the presence, profile, or change in circulating tumor DNA (ctDNA) mutations in plasma samples to characterize molecular features potentially associated with treatment response, sensitivity, or resistance.
Time frame: Blood: Cycle 1 Day 1 (baseline), Cycle 1 Day 8, and Day 1 of Cycles 2, 3, 5, 7, and 9. Study cycles for biomarker assessments are 21 days (Q3W immunotherapy schedule).
Changes in Genomic Alteration Profile
This outcome will assess the presence, profile, or change in genomic alterations in plasma and tumor samples to characterize molecular features potentially associated with treatment response, sensitivity, or resistance.
Time frame: Tumor: baseline and Cycle 2 Day 1. Blood: Cycle 1 Day 1 (baseline), Cycle 1 Day 8, and Day 1 of Cycles 2, 3, 5, 7, and 9. Study cycles for biomarker assessments are 21 days.
Tumor Mutation Burden
This outcome will assess tumor mutation burden in tumor samples to characterize molecular features potentially associated with treatment response, sensitivity, or resistance.
Time frame: Baseline and Cycle 2 Day 1, prior to study treatment dosing on Cycle 2 Day 1. Study cycles for biomarker assessments are 21 days.
Change in CD8 Expression in the Tumor Microenvironment
This outcome will assess CD8 expression and/or spatial distribution in tumor samples using IHC or other applicable assays to characterize changes in the tumor immune microenvironment associated with study treatment.
Time frame: Baseline and Cycle 2 Day 1, prior to study treatment dosing on Cycle 2 Day 1. Study cycles for biomarker assessments are 21 days.
Change in PD-L1 Expression in the Tumor Microenvironment
This outcome will assess PD-L1 expression and/or spatial distribution in tumor samples using IHC or other applicable assays to characterize changes in the tumor immune microenvironment associated with study treatment.
Time frame: Baseline and Cycle 2 Day 1, prior to study treatment dosing on Cycle 2 Day 1. Study cycles for biomarker assessments are 21 days.
Percentage of Participants With Adverse Events
The percentage of participants with at least one adverse event (AE). AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and severity will be graded according to NCI CTCAE Version 5.0.
Time frame: From first dose of study treatment through 30 days after cessation of study intervention.
Percentage of Participants With Grade 3 to 5 Adverse Events
The percentage of participants with at least one Grade 3, 4, or 5 AE. AEs will be coded using MedDRA and severity will be graded according to NCI CTCAE Version 5.0.
Time frame: From first dose of study treatment through 30 days after cessation of study intervention.
Percentage of Participants With Serious Adverse Events
The percentage of participants with at least one serious adverse event (SAE), defined according to protocol-specified ICH/GCP seriousness criteria. SAEs will be coded using MedDRA and severity graded according to NCI CTCAE Version 5.0.
Time frame: From first dose through 90 days after cessation of study intervention, or through 30 days if new anticancer therapy starts, whichever is earlier.
Percentage of Participants With Treatment-Related Adverse Events
The percentage of participants with at least one AE assessed by the investigator as related to study intervention. AEs will be coded using MedDRA and severity graded according to NCI CTCAE Version 5.0.
Time frame: From first dose of study treatment through 30 days after cessation of study intervention.
Change From Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg) as part of protocol-defined vital sign assessments.
Time frame: Screening; Cycle 1 Days 1 and 8; Day 1 of Cycles 2-9; Day 1 during maintenance; end of treatment; and 30-day safety follow-up.
Change From Baseline in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg) as part of protocol-defined vital sign assessments.
Time frame: Screening; Cycle 1 Days 1 and 8; Day 1 of Cycles 2-9; Day 1 during maintenance; end of treatment; and 30-day safety follow-up.
Change From Baseline in Pulse Rate
Change from baseline in pulse rate, measured in beats per minute as part of protocol-defined vital sign assessments.
Time frame: Screening; Cycle 1 Days 1 and 8; Day 1 of Cycles 2-9; Day 1 during maintenance; end of treatment; and 30-day safety follow-up.
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate, measured in breaths per minute as part of protocol-defined vital sign assessments.
Time frame: Screening; Cycle 1 Days 1 and 8; Day 1 of Cycles 2-9; Day 1 during maintenance; end of treatment; and 30-day safety follow-up.
Change From Baseline in Body Temperature
Change from baseline in body temperature, measured in degrees Celsius as part of protocol-defined vital sign assessments.
Time frame: Screening; Cycle 1 Days 1 and 8; Day 1 of Cycles 2-9; Day 1 during maintenance; end of treatment; and 30-day safety follow-up.
Change From Baseline in Body Weight
Change from baseline in body weight, measured in kilograms as part of protocol-defined vital sign assessments.
Time frame: Screening; Cycle 1 Days 1 and 8; Day 1 of Cycles 2-9; Day 1 during maintenance; end of treatment; and 30-day safety follow-up.
Change From Baseline in ECOG Performance Status
Change from baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status score, assessed using the protocol-defined 0-to-5 ECOG scale, where higher scores indicate worse functional status.
Time frame: Screening; Cycle 1 Days 1 and 8; Day 1 of Cycles 2-9; Day 1 during maintenance; end of treatment; and 30-day safety follow-up.
Percentage of Participants With Adverse Events Leading to Permanent Study Treatment Discontinuation
The percentage of participants with at least one AE resulting in permanent discontinuation of any study treatment. AEs will be coded using MedDRA and severity graded according to NCI CTCAE Version 5.0.
Time frame: From first dose until permanent discontinuation of any study treatment, up to 24 months.
Percentage of Participants With Immune-Mediated Adverse Events
The percentage of participants with at least one immune-mediated adverse event (imAE), identified according to protocol-defined immune-mediated toxicity criteria. Events will be coded using MedDRA and severity graded according to NCI CTCAE Version 5.0.
Time frame: From first dose through 30 days after cessation of study intervention; serious immune-mediated events through 90 days, or 30 days if new anticancer therapy starts, whichever is earlier.
Start is estimated for Dec 2026; primary completion for Jun 2030, 42 months later.
Of 293 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 76. This study's planned 42 months is below that.
Counting every sponsor, half of 358 studies reached it within 50 months; a quarter within 31 and three quarters within 75.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 12, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rilvegostomig
Vall d'Hebron Institute of Oncology