A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab

Summary

This is a dose escalation protocol to determine the feasibility of co-administration of RRx-001 and nivolumab. Immune surveillance is an endogenous mechanism to cause remission of neoplastic growth. Epigenetic agents like RRx-001 are associated not only with enhanced gene transcription and restored expression of silenced genes but also with increased expression of pro-inflammatory mediators, upregulation of PD-L1 on tumor cells and de-repression of antigens that promote immune recognition of tumors. It is hypothesized that RRx-001, will prime or sensitize to immune checkpoint therapy targeting PD-1 interaction with nivolumab.

Timeline

Start

2015-07-21

Primary completion

2016-05-17

Completion

2016-09-12

Publications

• Reid T, Oronsky B, Caroen S, Quinn M, Williams J, Cabrales P, Abrouk N. Phase 1 pilot study of RRx-001 + nivolumab in patients with advanced metastatic cancer (PRIMETIME). Front Immunol. 2023 Mar 7;14:1104753. doi: 10.3389/fimmu.2023.1104753. eCollection 2023.

Drugs

Indications