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New treatment option for Cutaneous Squamous Cell Carcinoma
Official title Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06567314
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, being studied as a potential treatment for cutaneous squamous cell carcinoma.
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
- To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.
- 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
- Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
- Age ≥18 years.
- Has locally advanced surgically non-appropriate (unresectable and/or metastatic) cSCC (Cohort 1)..
- Has metastatic CRPC (Cohort 2):
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
You likely can't join if
- Patients who have previously been treated with PD-1/PD-L1 inhibitors and required permanent discontinuation, or systemic immunosuppression due to...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab.
- Pregnant or breastfeeding.
- Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone...
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Known history of acute or chronic hepatitis B virus or hepatitis C virus infection.
See the full eligibility criteria
Who can join
- Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
- Age ≥18 years.
- Has locally advanced surgically non-appropriate (unresectable and/or metastatic) cSCC (Cohort 1)..
- Has metastatic CRPC (Cohort 2):
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
- Documented prostate cancer progression as documented by PSA progression according to PCWG3 criteria.
- Surgically or medically castrated, with serum testosterone level \<50 ng/dL.
- Refractory or naïve to anti-PD-1 therapy (Cohort 1). There is no limit on the number of prior lines of therapy. NOTE: Detailed information regarding duration of prior anti-PD-1 therapy and the extent of progression at...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).
- Cohort 1: measurable disease per the RECIST v1.1 or Measurable by mRECIST for skin cancer or Global Assessment or Papillary/Ulceration Response Assessment or Pathological Assessment or WHO Criteria for Response...
- Adequate organ and marrow function as defined below within 28 days of study treatment initiation:
- Hemoglobin \>9.0 g/dL
- Absolute neutrophil count ≥1500/mL
- Platelets ≥100,000/mL
- Total bilirubin ≤1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.
- AST/alanine transaminase ≤2.5 × institutional ULN. Transaminases up to 3 × ULN in the presence of liver metastases.
- Serum creatinine ≤1.5 × ULN OR measured or calculated creatinine clearance (CrCl; glomerular filtration rate can also be used in place of creatinine or CrCl) ≥60 mL/min for participants with creatinine levels \>1.5 ×...
- Urine protein \<2+ or 24-hour urine protein quantification \<1.0 g
- For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant...
- Albumin \>2.5 mg/dL.
- Participants must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 2 weeks or 5 half-lives (whichever is shorter) from...
- Prior treatment with anti-VEGF therapy is allowed (Cohort 1).
- Adequately controlled blood pressure with 0 or 1 antihypertensive medication (defined as blood pressure ≤150/100 mmHg at screening and no changes in antihypertensive medication within 7 days of Day 1 Cycle 1.
- Women of childbearing potential (WOCBP) should have a negative urine or serum pregnancy within 72 hours prior to study treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum...
- WOCBP must agree to use adequate contraception during the study treatment period and for 120 days after completion of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has...
- Male participants of childbearing potential must agree to use adequate contraception during the study treatment period and for 120 days after completion of study treatment.
What rules you out
- Patients who have previously been treated with PD-1/PD-L1 inhibitors and required permanent discontinuation, or systemic immunosuppression due to irAEs.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab.
- Pregnant or breastfeeding.
- Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or...
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Known history of acute or chronic hepatitis B virus or hepatitis C virus infection.
- Previous solid organ or allogeneic hematopoietic stem cell transplant.
- Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
- Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include...
- Major blood vessel invasion.
- Major surgical procedures or serious trauma within 4 weeks prior to study treatment initiation, or plans for major surgical procedures within 4 weeks after the first dose of study treatment (as determined by the...
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification Grade ≥2) or vascular disease (e.g., aortic aneurysm at risk of rupture) that required hospitalization...
- History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to study treatment initiation.
- History of arterial thromboembolic event, venous thromboembolic event of Grade ≥3 as specified in NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy...
- Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to study treatment initiation.
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection...
- Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation, or anticipation of need for such a vaccine during the course of the study.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative...
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- Inability to comply with the study and follow-up procedures.
- Participants who are receiving any other investigational agents.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
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.