Status and phase
Conditions
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Study type
Funder types
Identifiers
About
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.
Full description
Primary Objective - To determine the ORR of ivonescimab in participants with cSCC
Secondary Objectives
Exploratory Objective
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Age ≥18 years.
Has advanced (unresectable and/or metastatic) cSCC.
Refractory to anti-PD-1 therapy. There is no limit on the number of prior lines of therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Measurable disease per the RECIST v1.1
Life expectancy ≥3 months per treating physician's discretion.
Adequate organ and marrow function as defined below within 28 days of study treatment initiation:
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 any targeted therapy or small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, mitomycin C, and nitrosoureas); 4 weeks from radiation therapy; and at least 2 weeks from palliative radiotherapy.
Prior treatment with anti-VEGF therapy is allowed.
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 pregnancy test will be required.
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 not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
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.
Exclusion criteria
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Central trial contact
Aung Naing, MD
Data sourced from clinicaltrials.gov
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