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

Completed · Phase 1

Conditions studied: Malignant Solid Tumor, Lymphoma

In brief

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.

Key facts

Study ID

NCT02518958

Run by

EpicentRx, Inc.

People needed

12

Starts

2015-07-21

Expected to finish

2016-09-12

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) or lymphoma that are either refractory or is intolerant to, or has refused all standard available life-prolonging therapies.
• Measurable or evaluable disease based on RECIST criteria version. 1.1.
• ECOG performance status is 0-2 at Screening.
• Acceptable liver function at Screening,
• Serum creatinine < 2x institution upper limit of normal
• Acceptable hematologic status at Screening
• Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.

You may not qualify if…

• Serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
• If female, subject is pregnant and/or breastfeeding.
• Subjects with active autoimmune disease or history of autoimmune disease that might recur and may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
• Subjects having a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
• Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, and anti-CD40 antibodies. However, prior exposure to RRx-001 is allowed.

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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