Informations générales (source: ClinicalTrials.gov)
Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
novembre 2025
septembre 2028
02 décembre 2025
The goal of this clinical trial is to evaluate the addition of ivonescimab to standard
chemotherapy in patients with advanced or metastatic gastric and gastroesophageal
adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab
increase the response to treatment ? Participants will visit the clinic every 2 weeks for
checkups, treatment administration and tests for collection of adverse events.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Val�rie BOIGE | 05/10/2026 14:20:02 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69008 - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut de Cancerologie de l'Ouest - Site René Gauducheau - Saint-Herblain 2979590 - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51100 - Reims 2984114 - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - Marseille 2995469 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
1. Signed a written informed consent form prior to any trial specific procedures. Note:
If the patient is physically unable to provide their written consent, a trusted
person of their choice, independent of the Investigator or the Sponsor, can confirm
the patients consent in writing.
2. Histologically or cytologically proven gastric cancer (GC) or esophagogastric
junction cancer adenocarcinoma (EGJC)
3. Metastatic or locally advanced non resectable (stage IV) disease.
4. Presence of at least one measurable lesion as assessed by the investigator according
to RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Age ≥18 years.
7. For patients without actionable biomarker (HER2 and Claudin 18.2-negative) except
for PD-L1, no prior treatment for advanced disease (cohort 1). For patients with at
least one of the following actionable biomarker (PD-L1 CPS≥1, and/or HER2-positive,
and/or Claudin 18.2-positive), who had received only one prior line of treatment for
advanced disease (cohort 2).
8. Adequate hematological function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L,
platelet count ≥100 × 10⁹/L, and hemoglobin ≥9 g/dL. Note: Blood transfusion or
growth factor therapy should not be performed within 7 days prior to the screening
hematology analysis.
9. Adequate renal function: estimated creatinine clearance ≥50 mL/min according to the
Cockcroft-Gault formula, or estimated glomerular filtration rate (eGFR) value ≥50
mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
equation, and urine protein < 2+ or 24-hour urine protein quantification < 1.0 g.
10. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal
(ULN) range (≤3 x ULN for patients with liver metastases or confirmed/suspected
Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) levels ≤2.5 × ULN (AST and ALT ≤5 x ULN when documented liver metastasis).
11. Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x
ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time
(aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy).This applies
only to patients who are not on therapeutic anti-coagulation. Patients receiving
therapeutic anti-coagulation should be on a stable dose.
12. Women of childbearing potential (WOCBP) having sex with an unsterilized male partner
and unsterilized males having sex with a female partner of childbearing potential,
must agree to use an effective method of contraception for the duration of trial
participation and as required after completing study treatment (120 days after the
last dose of ivonescimab). Men must also agree to not donate sperm and women must
agree to not donate oocytes during the specified period.
13. WOCBP must have a negative serum pregnancy test performed within 3 days before
inclusion and a negative urine pregnancy test on the day of first dose, prior to
treatment administration.
14. Willing and able to comply with the protocol for the duration of the study including
scheduled visits, treatment plan, laboratory tests, and other study procedures
15. Affiliation to the Social Security System (or equivalent)
Exclusion Criteria:
1. Previous or concurrent cancer that is distinct in primary site or histology from
gastroesophageal cancer within 2 years prior to study inclusion, except for
curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial
bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (lamina
propria invasion)].
2. Patients with high microsatellite instability (MSI-H) or mismatched repair disease
(dMMR) tumor.
3. Enteral intake < 1500 kcal /d and or a weight loss > 15% of total body weight within
the 6 months
4. Toxicities from previous treatment not resolved to grade ≤ 1 (according to the
version 5.0 of the National Cancer Institute - Common terminology criteria for
adverse events [NCI-CTCAE v5.0]) before treatment start with the exception of
alopecia.
5. Major surgical procedures or serious trauma within 4 weeks prior to treatment start,
or plans for major surgery within 4 weeks after the first dose (as determined by the
investigator). Minor local procedures (excluding central venous catheterization and
port implantation) within 3 days prior to treatment start.
6. History of bleeding tendencies or coagulopathy and/or clinically significant
bleeding symptoms or risk within 4 weeks prior to inclusion, including but not
limited to:
1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood
clots), Note: transient hemoptysis associated with diagnostic bronchoscopy is
allowed.
2. Nasal bleeding /epistaxis (bloody nasal discharge is allowed),
3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents
for therapeutic purposes that is not stable prior to treatment start is not
allowed. The use of full-dose anticoagulants is permitted as long as the
international normalized ratio (INR) or activated partial thromboplastin time
(aPTT) is within therapeutic limits according to the medical standard of the
enrolling institution.
7. Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or
diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
8. History of major diseases before inclusion, specifically:
1. Unstable angina, myocardial infarction, congestive heart failure (New York
Heart Association classification ≥ grade 2) or unstable vascular disease (eg,
aortic aneurysm at risk of rupture, Moyamoya disease) that required
hospitalization within 12 months prior to inclusion, or other cardiac
impairment that may affect the safety evaluation of the study drug (eg, poorly
controlled arrhythmias, myocardial ischemia),
2. History of esophageal gastric varices, severe ulcers, wounds that do not heal,
abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal
bleeding within 6 months before inclusion,
3. History of any grade arterial thromboembolic event, venous thromboembolic event
of Grade 3 and above as specified in NCI-CTCAE v5.0, transient ischemic attack,
cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy
within 12 months prior to inclusion,
4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks
before inclusion,
5. History of perforation of the gastrointestinal tract and/or fistula, history of
gastrointestinal obstruction (including incomplete intestinal obstruction
requiring parenteral nutrition), extensive bowel resection (partial colectomy
or extensive small bowel resection) within 6 months prior to inclusion.
9. Imaging during the screening period shows that the patient has:
1. Radiologically documented evidence of major blood vessel invasion or encasement
by cancer,
2. Radiographic evidence of intra-tumor cavitation.
3. Evidence of higher bleeding risk on prostheses
10. Any immunosuppressive therapy during more than 7 days (i.e. corticosteroids >10mg or
equivalent dose) within 14 days before the planned start of study therapy.
Physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency is not considered as a form of systemic treatment.
11. Active autoimmune disease that has required a systemic treatment in past 2 years
(i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g.
thyroxine, insulin) is allowed active or history of autoimmune disease or immune
deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune
hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel
disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren
syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following
exceptions:
1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid
replacement hormone are eligible for the study,
2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen
are eligible for the study,
3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis are
excluded) are eligible for the study provided all of following conditions are
met:
I. Rash must cover < 10% of body surface area, II. Disease is well controlled at
baseline and requires only low-potency topical corticosteroids, III. No occurrence
of acute exacerbations of the underlying condition requiring psoralen plus
ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin
inhibitors, or high potency or oral corticosteroids within the previous 12 months.
12. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
13. Known history of, or any evidence of, interstitial lung disease.
14. Patient with non-controlled human immunodeficiency virus (HIV) (positive HIV 1/2
antibodies) infection (patient with undetectable viral load (HIV RNA PCR) and CD4
above 350 either spontaneously or on stable anti-viral regimen).
15. Chronic hepatitis B or C infection (if hepatitis status cannot be obtained from
medical records, re-testing is required)
16. In case of planned treatment with fluorouracil, proven complete deficiency of
dihydropyrimidine dehydrogenase (DPD).
17. Any condition which in the Investigator's opinion makes it undesirable for the
subject to participate in the trial or which would jeopardize compliance with the
protocol.
18. Pregnant or breast-feeding females.
19. Participation in another therapeutic trial within the 30 days prior to entering the
study. Participation in an observational trial would be acceptable.
20. Patients unwilling or unable to comply with the medical follow-up required by the
trial because of geographic, familial, social, or psychological reasons.
21. Individuals deprived of liberty or placed under protective custody or guardianship