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Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
NCT03891953 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.
Conditions Studied
Interventions
- DRUG DKY709
- DRUG PDR001
Study Locations (9)
Other
- Novartis Investigative Site — Essen
- Novartis Investigative Site — Hong Kong
- Novartis Investigative Site — Barcelona
- Novartis Investigative Site — Taipei
Massachusetts
- Massachusetts General Hospital — Boston
- Dana Farber Cancer Institute — Boston
Tennessee
- Sarah Cannon Research Institute — Nashville
Saxony
- Novartis Investigative Site — Dresden
Tokyo
- Novartis Investigative Site — Chuo Ku
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2019-05-07 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03891953
The ClinicalTrials.gov registry entry for NCT03891953 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 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions — of which DKY709 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: NCT03891953 reports 9 study locations spanning 5 distinct geographic areas — top geographies include Other, Massachusetts, Tennessee. 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 NCT03891953 about?
NCT03891953 is a clinical study titled "Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.". This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD...
What is the current status of trial NCT03891953?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2019-05-07. Estimated completion is 2026-10-31.
What conditions does trial NCT03891953 study?
This clinical trial studies the following conditions: Melanoma, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer, Nasopharyngeal Carcinoma, Microsatellite Stable Colorectal 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 NCT03891953?
The interventions under investigation include: DKY709 (DRUG), PDR001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03891953?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03891953 being conducted?
This trial has 9 study locations across Massachusetts, Tennessee, Saxony, Tokyo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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