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NCT03030378 · ClinicalTrials.gov registry record · Phase 1

Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors

A Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
36
Enrollment target
20
Study locations

NCT03030378 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT03030378, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
20
Study locations

Study Summary

This phase I trial studies the side effects and best dose of pembrolizumab and recombinant interleukin-12 in treating patients with solid tumors. 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. Recombinant interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12 may work better than giving pembrolizumab alone in treating patients with solid tumors.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • BIOLOGICAL Edodekin alfa

Study Locations (20)

Missouri

  • Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
  • Siteman Cancer Center at West County Hospital - Creve Coeur
  • Washington University School of Medicine - St Louis
  • Siteman Cancer Center-South County - St Louis
  • Siteman Cancer Center at Christian Hospital - St Louis

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston
  • Brigham and Women's Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston

Georgia

  • Emory University Hospital Midtown - Atlanta
  • Emory University Hospital/Winship Cancer Institute - Atlanta
  • Emory Saint Joseph's Hospital - Atlanta

California

  • University of California Davis Comprehensive Cancer Center - Sacramento
  • UCSF Medical Center-Mount Zion - San Francisco

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital - New Haven
  • Yale University - New Haven

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Florida

  • UF Health Cancer Institute - Gainesville - Gainesville

Iowa

  • University of Iowa/Holden Comprehensive Cancer Center - Iowa City

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2018-05-30
Est. Completion 2026-06-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03030378

The ClinicalTrials.gov registry entry for NCT03030378 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (83% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03030378 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Missouri, Massachusetts, Georgia.

Frequently Asked Questions

What is clinical trial NCT03030378 about?

NCT03030378 is a clinical study titled "Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors". This phase I trial studies the side effects and best dose of pembrolizumab and recombinant interleukin-12 in treating patients with solid tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability o...

What is the current status of trial NCT03030378?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-05-30. Estimated completion is 2026-06-01.

What conditions does trial NCT03030378 study?

This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.

What interventions are being tested in trial NCT03030378?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Edodekin alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT03030378?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03030378 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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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