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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 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.

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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.

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

FieldValue
Enrollment Target 32 participants
Start Date 2018-08-27
Est. Completion 2026-05-31
Phase Phase 2

Sponsor

Nicholas Fidelman, MD

1 total trials

What the Registry Record Tells You About NCT03457948

The ClinicalTrials.gov registry entry for NCT03457948 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 13 other Metastatic Malignant Neoplasm in the Liver trials with a reported enrollment target (64% lower). The listed sponsor is Nicholas Fidelman, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Similar trials for Metastatic Malignant Neoplasm in the Liver

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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