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NCT04616248 · ClinicalTrials.gov registry record · Phase 1
In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors
A Phase 1 study of Metastatic Melanoma and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by University of Southern California.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT04616248: Active Phase 1 study of Metastatic Melanoma and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by University of Southern California.
NCT04616248 is a Phase 1 study of Metastatic Melanoma and Anatomic Stage IV Breast Cancer AJCC v8 that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 14 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616248, a Phase 1 study of Metastatic Melanoma and Anatomic Stage IV Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2028-01-09 |
| Phase | Phase 1 |
What the registry record for NCT04616248 still lists
NCT04616248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (83% lower).
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.
NCT04616248 reports a single indexed study location in California.
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.
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).
Who is sponsoring clinical trial NCT04616248?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT04616248's enrollment target sits among peer trials
14 83rd of 91 higher than 8 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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