Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ccRCC.
Eligibility criteria
Qualifiers
Participants with histologically or cytologically confirmed metastatic/advanced clear cell RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting, including a PD-1/PD-L1 checkpoint inhibitor administered in metastatic/advanced setting.
Participants in cohort 1 must have not received a treatment containing a VEGF- or HIF2a(- directed agent in prior treatment lines of treatment for metastatic/advanced RCC
Participants in cohort 2 must have had progression on or after at least one prior line of treatment containing a VEGF-directed agent in prior lines of therapy
Participants must have had evidence of disease progression on or after last treatment regimen received.
Disqualifiers
Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or postradiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early stage prostate adenocarcinoma with negligible risk of metastasis or death.
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 enrollment.
Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after adequate oral antihypertensive therapy.
Nasal bleeding /epistaxis. Bloody nasal discharge is allowed.
Trial design
Treatments tested in this trial
- Ivonescimab
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Strategic Alliance
Collaborator
Summit Therapeutics
Collaborator
Source ClinicalTrials.gov