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NCT03891953 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
A Phase 1 study of Melanoma and Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
- 9
- Study locations
NCT03891953: Active Phase 1 study of Melanoma and Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
NCT03891953 is a Phase 1 study of Melanoma and Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 98 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03891953, a Phase 1 study of Melanoma and Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Incidence and severity of AEs and SAEs
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 |
What the registry record for NCT03891953 still lists
NCT03891953 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower).
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.
NCT03891953 lists 9 locations in 5 states (Other, Massachusetts, Tennessee).
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.
What interventions are being tested in trial NCT03891953?
The interventions under investigation include: DKY709 (DRUG), PDR001 (DRUG).
Who is sponsoring clinical trial NCT03891953?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03891953's enrollment target sits among peer trials
98 114th of 266 higher than 152 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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