2024-520045-23-00
Not yet recruiting
Phase 2
A Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer
ARTIC16 sites in 1 country200 target enrollmentStarted: January 30, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- ARTIC
- Enrollment
- 200
- Locations
- 16
- Primary Endpoint
- Investigator-assessed ORR is defined as the proportion of randomized subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST 1.1 criteria based on Investigator assessments.
Overview
Brief Summary
To evaluate the ORR according to molecular subgroups (ccRCC1 to 4)and assigned treatment (nivolumab monotherapy, nivolumab combined with ipilimumab, or TKI: sunitinib or pazopanib), based on Investigator assessments.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Design of the study
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological confirmation of RCC with a clear-cell component. Patients with TFE3 or TFEB translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH) are eligible.
- •Metastatic (American Joint Committee on Cancer [AJCC] Stage IV) RCC
- •No prior systemic therapy for mRCC (patients with relapse >1 year after adjuvant treatment discontinuation are eligible)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
- •Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Frozen tumor samples or fresh tumor samples immediately stored in "RNA later" medium (primary tumor and/or metastasis biopsies) must be available and received by the central laboratory (Cordelier Research Center) to determine molecular groups. (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission).
- •Formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for biomarker (gene expression and immunohistochemistry (IHC)) analysis
- •Molecular group has to be determined prior to randomization.
Exclusion Criteria
- •Any untreated CNS metastases. Patients with CNS metastases will be eligible if they are: asymptomatic, without significant edema, not on corticosteroids, not eligible for radiation therapy/surgery or have already received radiation therapy.
- •History of cerebrovascular accident including transient ischemic attack within the past 12 months.
- •History of DVT unless adequately treated with low molecular weight heparin
- •History of pulmonary embolism within the past 6m unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks
- •Known history of COPD
- •Known history of uveitis or complaint of double vision
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
- •Serious, non-healing wound or ulcer
- •Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 30 days.
- •Any requirement for anti-coagulation, except for low molecular weight heparin
Outcomes
Primary Outcomes
Investigator-assessed ORR is defined as the proportion of randomized subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST 1.1 criteria based on Investigator assessments.
Investigator-assessed ORR is defined as the proportion of randomized subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST 1.1 criteria based on Investigator assessments.
Secondary Outcomes
- Progression-free Survival The primary definition of PFS is specified as the time between randomization to the first date of documented progression, based on Investigator radiological assessments (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.
- Overall Survival OS is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (“last known alive date”).
- Objective response rate at 22 weeks ORR at 22 weeks as defined as percentage of patients with an objective response (decrease of SLD by at least 30%) at second CT or MRI after treatment initiation.
- Duration of treatment Duration of treatment (DOT) is defined as the time between treatment initiation and discontinuation for any reason or End of study.
- Duration of response Duration of response (DOR) is defined as the time between response to treatment and discontinuation for any reason or End of study.
- AE Incidence Rate The AE incident rate is defined as the proportion of subjects with any-grade AEs among subjects in each treatment arm. Events reported from the first dose, up to and including 100 days following the last dose of study treatment will be included in calculating this incidence rate
Investigators
Professor
Scientific
ARTIC
Study Sites (16)
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