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NCT05746208 · ClinicalTrials.gov registry record · Phase 2
Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
A Phase 2 study of Neuroendocrine Tumors and Well-Differentiated Neuroendocrine Carcinoma, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT05746208: Recruiting Phase 2 study of Neuroendocrine Tumors and Well-Differentiated Neuroendocrine Carcinoma, sponsored by University of California, San Francisco.
NCT05746208 is a Phase 2 study of Neuroendocrine Tumors and Well-Differentiated Neuroendocrine Carcinoma that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 29 participants, below the 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05746208, a Phase 2 study of Neuroendocrine Tumors and Well-Differentiated Neuroendocrine Carcinoma, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This is the first study to be done in a newly described class of neuroendocrine tumors known as well-differentiated grade 3 neuroendocrine tumors (WD G3 NET). First described in the pancreas in 2017, the classification was broadened to include gastrointestinal tract tumors in 2019. Recent data suggest an equivalent subtype exists in the lungs (NEC with carcinoid morphology). WD G3 NETs can occur de novo as well as the result of grade progression over time. This is a single arm, multi-site, Phase II study in biomarker "unselected" participants. This study will also incorporate serial blood samples, tumor biopsies, and special imaging to better understand the impact of therapy on the tumor and microenvironment. Hyperpolarized (HP) 13C-pyruvate magnetic resonance imaging (MRI) - a novel non-radioactive imaging modality able to provide in vivo measurements of the pyruvate-to-lactate conversion rate (kpl).
Primary Outcome
ORR is defined as a complete response (CR) or a partial response (PR) according to RECIST version 1.1 criteria. The All Subjects as Treated (ASaT, ITT) population will be used for analysis which consists of all participants who received at least one dose of the study treatment. Participants without at least confirmatory scan will be classified as non-responders. The point estimate and 95% confidence interval will be reported.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Hyperpolarized 13C-Pyruvate
- DRUG Lenvatinib
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-07-17 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 2 |
What NCT05746208 shows while recruiting
NCT05746208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05746208 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05746208 about?
NCT05746208 is a clinical study titled "Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors". This is the first study to be done in a newly described class of neuroendocrine tumors known as well-differentiated grade 3 neuroendocrine tumors (WD G3 NET). First described in the pancreas in 2017, the classification was broadened to include gastrointestinal tract tumors in 2019. Recent data sugge...
What is the current status of trial NCT05746208?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2023-07-17. Estimated completion is 2028-03-31.
What conditions does trial NCT05746208 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors, Well-Differentiated Neuroendocrine Carcinoma, High Grade Neuroendocrine Carcinoma, Any Site.
What interventions are being tested in trial NCT05746208?
The interventions under investigation include: Pembrolizumab (DRUG), Hyperpolarized 13C-Pyruvate (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT05746208?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05746208 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05746208's enrollment target sits among peer trials
29 38th of 52 higher than 15 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors 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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