Cutaneous Squamous Cell CarcinomaPhase 2NCT06567314
Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma
A Phase 2 study testing Ivonescimab in people with Cutaneous Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Ivonescimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 1 Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
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- 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 the time of anti-PD-1 therapy discontinuation will be collected.
- 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 Assessment in Cutaneous Squamous Cell Carcinoma, as appropriate (Appendix 4).
- 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 × institutional ULN (CrCl should be calculated per institutional standard).
- 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 regimen.
- 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 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 (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 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.
Who cannot join
- 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 alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- 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.
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- 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 endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy.
- 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 investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to study treatment initiation.
- 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 within 12 months prior to study treatment initiation, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).
- 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 within 6 months prior to study treatment initiation.
- 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 (partial colectomy or extensive small bowel resection) within 6 months prior to study treatment initiation.
- 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 therapy, or in situ cervical cancer.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Aung Naing, MD, 713-563-3885, anaing@mdanderson.org
Aung Naing, MD
About this study
Official title: Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma and Castration-resistant Prostate Cancer
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.
Read the detailed description
Primary Objective
- To determine the ORR of ivonescimab in patients with cSCC and CRPC
Secondary Objectives
- To evaluate other indicators of the antitumor efficacy of ivonescimab in patients with cSCC and CRPC.
- To evaluate the safety and tolerability of ivonescimab in patients with cSCC and CRPC
Exploratory Objective
- To evaluate potential predictors of response and resistance to ivonescimab
- To bank pre-treatment blood samples for future correlative analyses
- To evaluate imaging characteristics predictive of treatment response and side effects
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Ivonescimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvonescimabDrug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab | Experimental | Participants found to be eligible to take part in this study, you will receive ivonescimab by vein over about 1-2 hours on Day 1 of each 21-day cycle (1 time every 3 weeks). Receives: Drug: Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start2 Dec 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Summit Therapeutics
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567314
- Sponsor's protocol ID
- 2024-0501
- Other IDs
- NCI-2024-07130
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma and Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06567314
- Acronym / sponsor ID
- 2024-0501
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Summit Therapeutics
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.
Detailed description
Primary Objective
- To determine the ORR of ivonescimab in patients with cSCC and CRPC
Secondary Objectives
- To evaluate other indicators of the antitumor efficacy of ivonescimab in patients with cSCC and CRPC.
- To evaluate the safety and tolerability of ivonescimab in patients with cSCC and CRPC
Exploratory Objective
- To evaluate potential predictors of response and resistance to ivonescimab
- To bank pre-treatment blood samples for future correlative analyses
- To evaluate imaging characteristics predictive of treatment response and side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab | Experimental | Drug: IvonescimabParticipants found to be eligible to take part in this study, you will receive ivonescimab by vein over about 1-2 hours on Day 1 of each 21-day cycle (1 time every 3 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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):
- 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 the time of anti-PD-1 therapy discontinuation will be collected.
Key exclusion criteria (23 listed)
- 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 alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvonescimabGiven by PO | Drug | Ivonescimab |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aung Naing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivonescimab in people with Cutaneous Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aung Naing, MD ((713) 563-3885, anaing@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.