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ACTIVE NOT RECRUITING Phase 1

In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors

NCT04616248 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial evaluates the safety and effectiveness of in situ immunomodulation with CDX-301, radiotherapy, CDX-1140 and Poly-ICLC (Cohort A) and these with intravenous (IV) pembrolizumab and subcutaneous (SC) tocilizumab (Cohort B) in treating patients with unresectable and measurable metastatic melanoma, cutaneous squamous cell carcinoma (SCC), basal cell carcinoma (BCC), Merkel cell carcinoma, high-grade bone and soft tissue sarcoma or HER2/neu(-) breast cancer. CDX-301 may induce cross-presenting dendritic cells, master regulators in the immune system. Radiation therapy uses high energy to kill tumor cells and release antigens that may be picked up, processed and presented by cross-presenting dendritic cells. CDX-1140 and Poly-ICLC may activate tumor antigen-loaded,cross-presenting dendritic cells, and generate tumor-specific T lymphocytes, a type of immune cells, that can search out and attack cancers. Giving immune modulators and radiation therapy may stimulate tumor cell death and activate the immune system.

Interventions

  • DRUG Pembrolizumab
  • RADIATION Radiation Therapy
  • DRUG Poly ICLC
  • BIOLOGICAL Anti-CD40 Agonist Monoclonal Antibody CDX-1140
  • BIOLOGICAL Recombinant Flt3 Ligand

Study Locations (2)

California

  • Los Angeles General Medical Center — Los Angeles
  • USC/Norris Comprehensive Cancer Center — Los Angeles

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2023-01-09
Est. Completion 2028-01-09
Phase Phase 1

Sponsor

University of Southern California

412 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04616248

The ClinicalTrials.gov registry entry for NCT04616248 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 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab 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: NCT04616248 reports 2 study locations spanning 1 distinct geographic area — top geographies include California. 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 NCT04616248 about?

NCT04616248 is a clinical study titled "In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors". This phase I trial evaluates the safety and effectiveness of in situ immunomodulation with CDX-301, radiotherapy, CDX-1140 and Poly-ICLC (Cohort A) and these with intravenous (IV) pembrolizumab and subcutaneous (SC) tocilizumab (Cohort B) in treating patients with unresectable and measurable metasta...

What is the current status of trial NCT04616248?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2023-01-09. Estimated completion is 2028-01-09.

What conditions does trial NCT04616248 study?

This clinical trial studies the following conditions: Metastatic Melanoma, Anatomic Stage IV Breast Cancer AJCC v8, Soft Tissue Sarcoma, Metastatic Breast Carcinoma, Merkel Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04616248?

The interventions under investigation include: Pembrolizumab (DRUG), Radiation Therapy (RADIATION), Poly ICLC (DRUG), Anti-CD40 Agonist Monoclonal Antibody CDX-1140 (BIOLOGICAL), Recombinant Flt3 Ligand (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04616248?

This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04616248 being conducted?

This trial has 2 study locations across California. 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