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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04616248
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-CD40 Agonist Monoclonal Antibody CDX-1140 — BIOLOGICAL
    Given IT
  • Poly ICLC — DRUG
    Given IT
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Recombinant Flt3 Ligand — BIOLOGICAL
    Given IT
  • Pembrolizumab — DRUG
    Given IV
  • Tocilizumab — DRUG
    Given SC

Study Details

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.

Key Dates

Start date
Jan 9, 2023
Status verified
Jan 2026
Primary completion
Jan 9, 2027
Completion
Jan 9, 2028

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (immunomodulators, radiation therapy)
    Patients receive recombinant Flt3 ligand IT on days 1-5 and undergo radiation therapy on day 8 or 9. Patients also receive agonistic anti-CD40 monoclonal antibody CDX-1140 IT and Poly-ICLC IT on day 9 or 10. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort B (immunomodulators, radiation therapy)
    Patients receive recombinant Flt3 ligand IT on days 1-5 and also receive pembrolizumab (IV), tocilizumab (SC) as well as undergo radiation therapy on day 8 or 9. Patients also receive agonistic anti-CD40 monoclonal antibody IT and IV over 90 minutes and Poly-ICLC IT on day 9 or 10. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By condition
Skin cancerMelanoma
By specialty
OncologySkin cancerDermatology
By research site
Los Angeles General Medical Center· Los Angeles, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CA

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