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New treatment option for Stomach Cancer Stage IV
Official title Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
ClinicalTrials.gov ID: NCT07070466
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, being studied as a potential treatment for stomach cancer stage iv.
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
- This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.
- 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
- Patients must have a pathologically confirmed diagnosis of adenocarcinoma of the esophagus, gastroesophageal junction, stomach. Squamous cell tumors...
- Participants must have disease that can be evaluated radiographically. This includes disease that may be measurable or non-measurable as per RECIST...
- Patients may not have received prior therapy for Stage IV disease. Patients may have received prior adjuvant therapy if more than 6 months have...
- Age ≥18 years old. Because there is no dosing or adverse event data for ivonescimab with FOLFOX in participants \<18 years of age, children are...
- ECOG Performance status of 0-2
You likely can't join if
- Prior treatment with a PD-1 or PD-L1 inhibitor is exclusionary unless this therapy was completed \> 6 months prior to the time of enrollment as part...
- Major surgical procedures or serious trauma within 4 weeks prior to enrolment, or plans for major surgical procedures within 4 weeks after the first...
- Participants who have not recovered from adverse events due to prior adjuvant anti-cancer therapy except for alopecia or peripheral neuropathy grade...
- Participants who are receiving any other investigational agents for this condition are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab. Patients with prior oxaliplatin...
- Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to...
See the full eligibility criteria
Who can join
- Patients must have a pathologically confirmed diagnosis of adenocarcinoma of the esophagus, gastroesophageal junction, stomach. Squamous cell tumors are excluded. Patients with locally tested HER2 positive tumors...
- Participants must have disease that can be evaluated radiographically. This includes disease that may be measurable or non-measurable as per RECIST version 1.1.
- Patients may not have received prior therapy for Stage IV disease. Patients may have received prior adjuvant therapy if more than 6 months have elapsed between the end of adjuvant therapy and registration.
- Age ≥18 years old. Because there is no dosing or adverse event data for ivonescimab with FOLFOX in participants \<18 years of age, children are excluded from this study.
- ECOG Performance status of 0-2
- Participants must meet the following organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/mcL
- hemoglobin \> 9.0 g/dL
- platelets ≥100,000/mcL
- total bilirubin ≤ 1.5x institutional upper limit of normal (ULN). For patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN. For patients with liver metastases, AST and ALT ≤ 5 × ULN
- Creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min.
- Urine protein \< 2+ or 24-hour protein quantification \< 1.0 grams.
- Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated...
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participants with brain metastases (active brain metastases) or leptomeningeal disease are not eligible. Patients with treated brain metastases who are off systemic steroids \> 2 weeks and have documented radiographic...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- The effects of ivonescimab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 9 months after completion of ivonescimab administration.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Prior treatment with a PD-1 or PD-L1 inhibitor is exclusionary unless this therapy was completed \> 6 months prior to the time of enrollment as part of adjuvant therapy.
- Major surgical procedures or serious trauma within 4 weeks prior to enrolment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures...
- Participants who have not recovered from adverse events due to prior adjuvant anti-cancer therapy except for alopecia or peripheral neuropathy grade 1 or less.
- Participants who are receiving any other investigational agents for this condition are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab. Patients with prior oxaliplatin and/or 5FU allergic reactions during adjuvant therapy are allowed if they...
- Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother...
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection...
- Clinically significant hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
- History of any grade arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient...
- Participants with a documented history of impaired wound healing are excluded.
- Participants with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Participants with uncontrolled intercurrent illness that would interfere with ability to participate in the opinion of the treating investigator.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that...
- people with any condition requiring systemic treatment with either corticosteroids (\>2mg daily dexamethasone equivalent) or other immunosuppressive medications within 14 days of treatment. Premedication for...
- Active systemic infection requiring intravenous antibiotics or intravenous monoclonal antibody treatments within 7 days of cycle 1 day 1.
- Participants with a known history of Human Immunodeficiency Virus (HIV) infection are excluded unless they meet all of the following criteria:
- Stable antiretroviral therapy (ART) for at least 12 weeks prior to enrollment
- No history of AIDS-defining conditions.
- CD4+ T-cell count ≥ 350 cells/mm³ at screening
- HIV viral load ≤ 50 copies/mL at screening.
- No significant comorbidities associated with HIV infection that could interfere with the safety or how well it works of the investigational treatment.
- No concurrent use of prohibited medications that may interfere with the study drug or cancer therapy
- History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, 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 randomization is not allowed. The use of full-dose anticoagulants is permitted as long...
- History of non-infectious pneumonitis requiring therapy within 4 weeks of registration.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- Boston, Massachusetts, United States
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 Santa Monica, California, United States; Boston, Massachusetts, United States. 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.