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NCT03301896 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03301896: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT03301896 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301896, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer. This was a multi-center, open-label Phase I/Ib study. The primary objectives of the trial were: * To characterize the safety and tolerability of intratumoral LHC165 in patients with solid tumors as a single agent and in combination with PDR001 * To determine and evaluate the maximum tolerated dose (MTD)/recommended dose (RD) for LHC165 as a single agent and in combination with PDR001
Primary Outcome
Dose Limiting Toxicity Evaluation Period
Interventions
- BIOLOGICAL PDR001
- DRUG LHC165
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 1 |
Why NCT03301896 stopped before completion
NCT03301896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which PDR001 is the first listed.
NCT03301896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03301896 about?
NCT03301896 is a clinical study titled "Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies". The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer. This was a multi-center, open-label Phase I/Ib study. The primary objectives of the trial were: * To characterize the safety and tolerability of intratumoral LHC165 in pati...
What is the current status of trial NCT03301896?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2018-01-31. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03301896?
The interventions under investigation include: PDR001 (BIOLOGICAL), LHC165 (DRUG).
Who is sponsoring clinical trial NCT03301896?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03301896's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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