Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03308396 · ClinicalTrials.gov registry record · Phase 1
Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer
A Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, sponsored by Ajjai Alva, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 5
- Study locations
NCT03308396 is a Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma that is active but no longer recruiting, run by Ajjai Alva, MD. The registered enrollment target is 57 participants, below the 879-participant average among 60 other Kidney Cancer trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT03308396, a Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Ajjai Alva, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 879-participant average among 60 other Kidney Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Ajjai Alva, MD, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT03308396 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Illinois, Iowa, Michigan.
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.
What interventions are being tested in trial NCT03308396?
The interventions under investigation include: Durvalumab (DRUG), Guadecitabine (DRUG).
Who is sponsoring clinical trial NCT03308396?
This trial is sponsored by Ajjai Alva, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Kidney Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Brodalumab in the Treatment of Immune-Related Adverse Events
RECRUITING · Phase 1
-
A Study of VET3-TGI in Patients With Solid Tumors
RECRUITING · Phase 1
-
Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors
ACTIVE NOT RECRUITING · Phase 1
-
NeoVax Plus Ipilimumab in Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 1
-
A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
ACTIVE NOT RECRUITING · Phase 1
-
HERV-E TCR Transduced Autologous T Cells in People With Metastatic Clear Cell Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.