Clinical trial NCT04616248: In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors
Official title: A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease
Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Unresectable Breast Carcinoma
Metastatic Melanoma
Unresectable Melanoma
Cutaneous Squamous Cell Carcinoma
Merkel Cell Carcinoma
Soft Tissue Sarcoma
Bone Sarcoma
Sarcoma,Soft Tissue
Sarcoma of Bone
Basal Cell Carcinoma
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:
description: Given IT
name: Anti-CD40 Agonist Monoclonal Antibody CDX-1140
other_name: Agonist CD40 Antibody CDX-1140
Anti-CD40 Agonistic Monoclonal Antibody CDX-1140
CDX 1140
CDX-1140
type: Biological
description: Given IT
name: Poly ICLC
other_name: Hiltonol
Poly I:Poly C with Poly-L-Lysine Stabilizer
PolyI:PolyC with Poly-L-Lysine Stabilizer
Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose
Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose
Stabilized Polyriboinosinic/Polyribocytidylic Acid
poly-ICLC
type: Drug
description: Undergo radiation therapy
name: Radiation Therapy
other_name: Cancer Radiotherapy
Irradiate
Irradiated
Irradiation
RT
Radiation
Radiation Therapy, NOS
Radiotherapeutics
Radiotherapy
Therapy, Radiation
type: Radiation
description: Given IT
name: Recombinant Flt3 Ligand
other_name: CDX-301
FLT 3 Ligand
FLT3 Ligand
Flt3-Ligand
Flt3L
Mobist
Mobista
rhuFlt3L
type: Biological
description: Given IV
name: Pembrolizumab
other_name: Keytruda
type: Drug
description: Given SC
name: Tocilizumab
other_name: Actemra
type: Drug
Study arms:
design_group_description: 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.
design_group_title: Cohort A (immunomodulators, radiation therapy)
design_group_type: Experimental
design_group_description: 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.
design_group_title: Cohort B (immunomodulators, radiation therapy)
design_group_type: Experimental
Sponsor: University of Southern California
Collaborators: National Institutes of Health
Drug name mappings:
name: 聚肌胞
lang: CN
name: Poly ICLC
lang: EN
name: CDX-1140
lang: EN
name: 托珠单抗
lang: CN
name: Tocilizumab
lang: EN
name: トシリズマブ（遺伝子組換え）
lang: JP
name: Fms-like tyrosine kinase 3 ligand(Amgen, Inc.)
lang: EN
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP