Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 (HER2+) tumors are excluded.
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.
Disqualifiers
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 enrollment, or plans for major surgical procedures 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 registration.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ivonescimab
DrugHumanized immunoglobulin G1 monoclonal antibody
5-Fluorouracil
DrugNucleoside metabolic inhibitor
Oxaliplatin
DrugPlatinum-based drug and organoplatinum complex
Leucovorin
Drug5-formyl derivative of tetrahydrofolic acid
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Ivonescimab plus FOLFOXExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
6-month progression free survival rate
The primary endpoint is to estimate the 6-month progression free survival rate for the combination of ivonescimab in combination with FOLFOX in frontline GEA adenocarcinomas. Progression is defined as measured from the start of the treatment with ivonescimab to the date of either documentation of disease progression or death. Progression of disease is defined per RECIST 1.1 criteria.
Time frame
From the start of treatment (Cycle 1, day 1) to first documented disease progression or date of death from any cause. Status at 6-months after starting treatment will be reported.Secondary outcomes
1
Incidence and Severity of Treatment-Emergent Adverse Events
Assessed using NCI Common Terminology for Adverse Event (CTCAE) version 5.0. All participants will be followed and assessed for safety and tolerability of the protocol therapy.
Time frame
From baseline until up to 90-days after end of study.2
Objective Response Rate
The percentage of participants that have a partial response or complete response.
Time frame
From baseline until end of study or death, whichever comes first for up to 5 years.3
Overall Clinical Benefit
This is defined by stable disease (SD), complete response rate (CR), or partial response (PR) assessed by RECISTv1.1. They will be summarized using binomial proportions along with exact 95% CI.
Time frame
From the baseline start of treatment to the date to first documented disease progression or date of death from any cause, whichever comes first for up to 5 years.4
Median Progression Free Survival and Overall Survival
Median progression free survival is the length of time during treatment and after treatment to disease progression or death. Overall survival is the time from start if treatment to death due to any cause. The Kaplan-Meier method will be used to estimate median progression free survival and overall survival.
Time frame
From baseline start of treatment to first documented disease progression or date of death from any cause, whichever comes first for up to 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Summit Therapeutics
Collaborator
Source ClinicalTrials.gov