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New treatment option for Metastatic Esophageal Adenocarcinoma
Official title Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
ClinicalTrials.gov ID: NCT06846346
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic esophageal adenocarcinoma.
Also referred to as AK112.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 ?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed a written informed consent form prior to any trial specific procedures. Note: If the patient is physically unable to provide their written...
- Histologically or cytologically proven gastric cancer (GC) or esophagogastric junction cancer adenocarcinoma (EGJC)
- Metastatic or locally advanced non resectable (stage IV) disease.
- Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- Previous or concurrent cancer that is distinct in primary site or histology from gastroesophageal cancer within 2 years prior to study inclusion...
- Patients with high microsatellite instability (MSI-H) or mismatched repair disease (dMMR) tumor.
- Enteral intake \ 15% of total body weight within the 6 months
- Toxicities from previous treatment not resolved to grade ≤ 1 (according to the version 5.0 of the National Cancer Institute - Common terminology...
- 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...
- History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to inclusion, including...
See the full eligibility criteria
Who can join
- 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...
- Histologically or cytologically proven gastric cancer (GC) or esophagogastric junction cancer adenocarcinoma (EGJC)
- Metastatic or locally advanced non resectable (stage IV) disease.
- Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age ≥18 years.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- 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
- Affiliation to the Social Security System (or equivalent)
What rules you out
- 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...
- Patients with high microsatellite instability (MSI-H) or mismatched repair disease (dMMR) tumor.
- Enteral intake \ 15% of total body weight within the 6 months
- 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...
- 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...
- 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:
- Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots), Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.
- Nasal bleeding /epistaxis (bloody nasal discharge is allowed),
- 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...
- Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
- History of major diseases before inclusion, specifically:
- 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...
- 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,
- 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...
- Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before inclusion,
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection...
- Imaging during the screening period shows that the patient has:
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer,
- Radiographic evidence of intra-tumor cavitation.
- Evidence of higher bleeding risk on prostheses
- 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...
- 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...
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,
- 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...
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Known history of, or any evidence of, interstitial lung disease.
- 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...
- Chronic hepatitis B or C infection (if hepatitis status cannot be obtained from medical records, re-testing is required)
- In case of planned treatment with fluorouracil, proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).
- 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.
- Pregnant or breast-feeding females.
- Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable.
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- Individuals deprived of liberty or placed under protective custody or guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Marseille, France
- Reims, France
- Saint-Herblain, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Marseille, France; Reims, France; Saint-Herblain, France. 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 ClinicalTrials.gov; the study team decides eligibility.