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ACTIVE NOT RECRUITING Phase 1

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

NCT03030378 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03030378

The ClinicalTrials.gov registry entry for NCT03030378 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03030378 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Missouri, Massachusetts, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03030378?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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