NCT03098160

Immunotherapy Study of Evofosfamide in Combination With Ipilimumab

A Phase 1 Immunotherapy Study of Evofosfamide in Combination With Ipilimumab in Patients With Advanced Solid Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Threshold Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An immunotherapy study combining ipilimumab and evofosfamide for the treatment of patients with confirmed metastatic or locally advanced prostate cancer, metastatic pancreatic cancer, melanoma or human papillomavirus (HPV) negative squamous cell carcinoma of head and neck that have failed to respond to standard therapy, progressed despite standard therapy, for which standard therapy does not offer the potential for increased survival.

Detailed description

Tumor hypoxia can lead to poor effector T cell penetration and immunosuppressive signaling via myeloid-derived suppressor, myofibroblast and regulatory T cells. Disruption of these hypoxic regions within the tumor microenvironment by the hypoxia-directed cytotoxic agent evofosfamide may enhance the ability of the CTLA-4 checkpoint inhibitor ipilimumab to reject otherwise resistant solid tumors. Additionally, induction of immunogenic cell death of tumor cells by evofosfamide may enhance dendritic cell presentation of tumor antigens to lymphocytes in draining lymph nodes, leading to clonal expansion of tumor-specific T cells, especially in combination with ipilimumab.

Conditions

• Pancreatic Cancer
• Melanoma
• Squamous Cell Carcinoma of the Head and Neck
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Evofosfamide	Evofosfamide given on day one and in combination with Ipilimumab on day 8 of the first two cycles, Ipilimumab given alone on day 8 of last two cycles for a total of four 21 day dosing cycles.
DRUG	Ipilimumab	Evofosfamide given on day one and in combination with Ipilimumab on day 8 of the first two cycles, Ipilimumab given alone on day 8 of last two cycles for a total of four 21 day dosing cycles.

Timeline

• Start date: 2017-05-10
• Primary completion: 2019-01-01
• Completion: 2019-04-01
• First posted: 2017-03-31
• Last updated: 2017-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study