BridgeMD
New treatment option for Metastatic Colorectal Cancer
Official title Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06959550
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 colorectal cancer.
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 research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.
- Phase 2: a mid-size study of how well it works
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
- Capable of giving signed informed consent
- Male and female adult participants 18 years of age or older on day of signing informed consent.
- Histological or cytological confirmed advanced, metastatic adenocarcinoma of colon or rectum.
- Known MMR or MSI status performed by local standard of practice. (e.g., IHC and/or PCR, next-generation sequencing)
- Cohort-specific criteria
You likely can't join if
- Any single liver metastasis \>5.0 cm (Cohort 2 only)
- Except for MSI-H/dMMR tumors, prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors (Cohorts 2 and 3 only).
- Patient who discontinued prior therapy with immune checkpoint inhibitors due to Grade 2 neurologic, cardiac, or ophthalmologic events or recurrent...
- Systemic anti-cancer treatment within 14 days or less than 5 half-lives (whichever is shorter) of the first dose of study treatment.
- Has unresolved clinically significant toxicity of greater than or equal to NCI Institute Common Terminology Criteria for AEs (CTCAE v5.0) grade 2...
- History of arterial thromboembolic event, venous thromboembolic event of grade 3 and above as specified in NCI CTCAE v5.0, transient ischemic attack...
See the full eligibility criteria
Who can join
- Capable of giving signed informed consent
- Male and female adult participants 18 years of age or older on day of signing informed consent.
- Histological or cytological confirmed advanced, metastatic adenocarcinoma of colon or rectum.
- Known MMR or MSI status performed by local standard of practice. (e.g., IHC and/or PCR, next-generation sequencing)
- Cohort-specific criteria
- Cohort 1: MSI-H/dMMR: ICI-refractory
- dMMR or MSI-H per local testing
- Demonstrated radiographic or clinical disease progression following treatment with immune checkpoint inhibitors including anti-PD-1 +/- anti-CTLA-4 therapy. If progression occurred after first imaging assessment, then...
- Must have received at least 2 doses of a PD1/PD-L1 inhibitor.
- Progressive disease either during therapy or within 3 months of last dose of therapy.
- No serious adverse immune-related adverse events (grade 3 or higher) with previous immune checkpoint therapy, that were symptomatic and required prolonged immunosuppression (\>6 weeks).
- Cohort 2: pMMR with liver metastases
- pMMR or non-MSI-H per local testing
- Presence of active liver metastases per radiographic imaging
- Patients with any bulky liver metastases measuring \>5.0 cm are not eligible
- Cohort 3: pMMR without liver metastases
- pMMR or non-MSI-H per local testing
- No liver metastases per radiographic imaging (note: previously treated or resected liver metastases are allowed if treatment was \>6 months prior without liver progression)
- Known extended RAS and BRAF status as per local standard of practice (Cohorts 2 and 3 only)
- Participant must have progressed (radiologically or clinically) or been intolerant to fluoropyrimidine, irinotecan, and oxaliplatin (Cohorts 2 and 3 only)
- Patient must have evidence of progression on or after the last treatment regimen received and within 6 months prior to study enrollment
- Patients who were intolerant to prior systemic chemotherapy regimens are eligible if there is documented evidence of clinically significant intolerance despite adequate supportive measures.
- Perioperative chemotherapy exposure can be considered if the participant had disease recurrence within 12 months of completion of neoadjuvant chemotherapy or 6 months of completion of adjuvant chemotherapy
- ECOG (Eastern Cooperative Oncology Group) PS of 0 to 1.
- Adequate hematologic and organ function as assessed by the following laboratory tests performed within 7 days before treatment initiation:
- Total bilirubin .1.5 x the upper limit of normal (ULN). Total bilirubin (.3 x ULN) is allowed if Gilbert fs syndrome is documented.
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) .2.5x ULN (.5 x ULN for patients with liver involvement of their cancer)
- Platelet count .100,000 /mm3, Hemoglobin (Hb) .9 g/dL, WBC .2000/ƒÊL absolute neutrophil count (ANC) .1500/mm3 without red blood cell transfusion or growth factor administered within 7 days of screening CBC.
- Serum creatinine .1.5 x ULN or creatinine clearance .50 mL/min (measured or calculated using the Cockroft-Gault formula)
- Prothrombin time-international normalized ratio (PT/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)...
- Estimated CrCl . 50 mL/min.
- Proteinuria . 30 mg/dL.
- Measurable disease as determined by iRECIST v1.1.
- Ability to provide recent tumor tissue is mandatory for all participants at screening, either through pre-treatment biopsy or archived tissue. For archived tissue, FFPE block or a minimum of 10 slides is recommended...
- Anticipated life expectancy greater than 3 months
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study intervention and 4 months after the last dose of study drug. Males who are sexually...
What rules you out
- Any single liver metastasis \>5.0 cm (Cohort 2 only)
- Except for MSI-H/dMMR tumors, prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors (Cohorts 2 and 3 only).
- Patient who discontinued prior therapy with immune checkpoint inhibitors due to Grade 2 neurologic, cardiac, or ophthalmologic events or recurrent Grade 2 pneumonitis are not eligible for the trial (Cohort 1 only).
- Systemic anti-cancer treatment within 14 days or less than 5 half-lives (whichever is shorter) of the first dose of study treatment.
- Has unresolved clinically significant toxicity of greater than or equal to NCI Institute Common Terminology Criteria for AEs (CTCAE v5.0) grade 2 attributed to any prior therapies (excluding anemia, lymphopenia...
- History of 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...
- 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...
- Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment
- Poorly controlled hypertension with repeated systolic blood pressure . 150 mmHg or diastolic blood pressure . 100 mmHg after oral antihypertensive therapy
- Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to randomization, however the...
- Know history of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominopelvic fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to enrollment
- History of perforation of the gastrointestinal tract and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), or extensive bowel resection (partial...
- History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, 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 enrollment is not permitted. The use of full-dose anticoagulants is permitted if the...
- people whose tumors invade peripheral important organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc), and who are at risk of esophageal tracheal fistula or...
- Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis . 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or...
- Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrollment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.
- Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring...
- Has pre-existing peripheral neuropathy that is . grade 2 per NCI CTCAE v5.0.
- 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...
- Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic. Note: Patients managed with indwelling catheters (e.g. PleurX) are allowed.
- History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
- Active or prior history of inflammatory bowel disease (eg, Crohn fs disease, ulcerative colitis, or chronic diarrhea)
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- Known allergy to any component of any study drug or known history of severe hypersensitivity to other monoclonal antibodies
- Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the...
- Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or...
- Pregnancy or breast feeding.
- Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.