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NCT03457948 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab With Liver-Directed or Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors and Liver Metastases
A Phase 2 study of Metastatic Malignant Neoplasm in the Liver and Neuroendocrine Neoplasm, sponsored by Nicholas Fidelman, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03457948: Active Phase 2 study of Metastatic Malignant Neoplasm in the Liver and Neuroendocrine Neoplasm, sponsored by Nicholas Fidelman, MD.
NCT03457948 is a Phase 2 study of Metastatic Malignant Neoplasm in the Liver and Neuroendocrine Neoplasm that is active but no longer recruiting, run by Nicholas Fidelman, MD. The registered enrollment target is 32 participants, below the 90-participant average among 13 other Metastatic Malignant Neoplasm in the Liver trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03457948, a Phase 2 study of Metastatic Malignant Neoplasm in the Liver and Neuroendocrine Neoplasm, is active but no longer recruiting, sponsored by Nicholas Fidelman, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot phase II trial studies how effective pembrolizumab and liver-directed therapy or peptide receptor radionuclide therapy are at treating patients with well-differentiated neuroendocrine tumors and symptomatic and/or progressive tumors that have spread to the liver (liver metastases). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Liver-directed therapies such as radiofrequency ablation, transarterial embolization, yttrium-90 microsphere radioembolization, and cryoablation may help activate the immune system in order to shrink tumors that are not being directly targeted. Peptide receptor radionuclide therapy is a form of targeted treatment that is performed by the use of a small molecule, which carries a radioactive component attached to a peptide. Once injected into the body, this small molecule binds to some specific sites on tumor cells called receptors and emit medium energy radiation that can destroy cells. Because this radionuclide is attached to the peptide, which binds receptors on tumor lesions, the radiation can preferably be targeted to the tumor cells in order to destroy them. Giving pembrolizumab in combination with liver-directed therapy or peptide receptor radionuclide therapy may work better than pembrolizumab alone.
Primary Outcome
The All Subjects as Treated (ASaT, ITT) population will be used for the analysis of ORR. The primary efficacy endpoint will be best observed Overall Response Rate (ORR) by RECIST 1.1 (investigator reported). ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). The proportion of participants with a response and 90% confidence interval of overall response rate will be obtained for each of the three groups separately
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Arterial Embolization
- BIOLOGICAL Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate
- DEVICE Yttrium-90 Microsphere Radioembolization
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
What the registry record for NCT03457948 still lists
NCT03457948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 90-participant average among 13 other Metastatic Malignant Neoplasm in the Liver trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Metastatic Malignant Neoplasm in the Liver appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03457948 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03457948 about?
NCT03457948 is a clinical study titled "Pembrolizumab With Liver-Directed or Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors and Liver Metastases". This pilot phase II trial studies how effective pembrolizumab and liver-directed therapy or peptide receptor radionuclide therapy are at treating patients with well-differentiated neuroendocrine tumors and symptomatic and/or progressive tumors that have spread to the liver (liver metastases). Immuno...
What is the current status of trial NCT03457948?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2018-08-27. Estimated completion is 2026-05-31.
What conditions does trial NCT03457948 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Liver, Neuroendocrine Neoplasm.
What interventions are being tested in trial NCT03457948?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Arterial Embolization (PROCEDURE), Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (BIOLOGICAL), Yttrium-90 Microsphere Radioembolization (DEVICE).
Who is sponsoring clinical trial NCT03457948?
This trial is sponsored by Nicholas Fidelman, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03457948 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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