Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer
NCT03308396 · View on ClinicalTrials.gov ↗
Study Summary
This is a single arm, multi-centre (via Big Ten Cancer Research Consortium) phase Ib/II study of patients treated with durvalumab 1500 mg IV q 4 weeks in combination with guadecitabine at the recommended phase 2 dose subcutaneously for 5 consecutive days. Eligible patients will have metastatic RCC with a clear cell component, ECOG performance status of 0-1, have received 0-1 prior therapy but no prior anti-PD-1/PD-L1/CTLA4 (Cohort 1, 36 subjects). Study treatment could potentially continue for up to 13 cycles (52 weeks).
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Guadecitabine
Study Locations (5)
Illinois
- Univerisity of Illinois Cancer Center — Chicago
Iowa
- University of Iowa Hosptials and Clinics — Iowa City
Michigan
- University of Michigan Comprehensive Cancer Center — Ann Arbor
New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick
Pennsylvania
- Penn State Cancer Institute — Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2023-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03308396
The ClinicalTrials.gov registry entry for NCT03308396 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ajjai Alva, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Kidney Cancer appearing as the primary indexed condition, and to 2 interventions — of which Durvalumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03308396 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Iowa, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03308396 about?
NCT03308396 is a clinical study titled "Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer". This is a single arm, multi-centre (via Big Ten Cancer Research Consortium) phase Ib/II study of patients treated with durvalumab 1500 mg IV q 4 weeks in combination with guadecitabine at the recommended phase 2 dose subcutaneously for 5 consecutive days. Eligible patients will have metastatic RCC w...
What is the current status of trial NCT03308396?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2017-12-19. Estimated completion is 2023-12.
What conditions does trial NCT03308396 study?
This clinical trial studies the following conditions: Kidney Cancer, Clear Cell Renal Cell Carcinoma, Advanced Kidney Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03308396?
The interventions under investigation include: Durvalumab (DRUG), Guadecitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03308396?
This trial is sponsored by Ajjai Alva, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03308396 being conducted?
This trial has 5 study locations across Illinois, Iowa, Michigan, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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