NCT02518958 (PRIMETIME) is a Phase 1 clinical trial of RRx-001 in Malignant Solid Tumor, sponsored by EpicentRx, Inc..

Who is sponsoring NCT02518958?

NCT02518958 is sponsored by EpicentRx, Inc..

What drugs are being tested in NCT02518958?

Interventions in NCT02518958: RRx-001, Nivolumab.

What condition does NCT02518958 study?

NCT02518958 studies Malignant Solid Tumor, Lymphoma.

Is NCT02518958 still recruiting?

NCT02518958 is currently completed. Last updated 18 November 2019.

Last reviewed 2019-11-18 · How we verify

NCT02518958: PRIMETIME

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 18 November 2019

What this trial tests

Phase 1 trial testing RRx-001 in Malignant Solid Tumor in 12 participants. Completed in 12 September 2016.

Timeline

21 July 2015

Primary endpoint
17 May 2016

12 September 2016

Quick facts

Lead sponsor	EpicentRx, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	21 July 2015
Primary completion	17 May 2016
Estimated completion	12 September 2016
Sites	1 location across United States

Drugs / interventions tested

RRx-001 — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Malignant Solid Tumor — all drugs for Malignant Solid Tumor →
Lymphoma — all drugs for Lymphoma →

Sponsor

EpicentRx, Inc. — full company profile →

Who can join

18 and older, any sex, with Malignant Solid Tumor or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Next generation of immune checkpoint inhibitors and beyond.
Marin-Acevedo JA, Kimbrough EO, Lou Y. · · 2021 · cited 401× · PMID 33741032 · DOI 10.1186/s13045-021-01056-8
NADPH homeostasis in cancer: functions, mechanisms and therapeutic implications.
Ju HQ, Lin JF, Tian T, Xie D, et al · · 2020 · cited 365× · PMID 33028807 · DOI 10.1038/s41392-020-00326-0
Immune checkpoint therapy in liver cancer.
Xu F, Jin T, Zhu Y, Dai C. · · 2018 · cited 299× · PMID 29843754 · DOI 10.1186/s13046-018-0777-4
Tumor-associated macrophages: an effective player of the tumor microenvironment.
Basak U, Sarkar T, Mukherjee S, Chakraborty S, et al · · 2023 · cited 212× · PMID 38035101 · DOI 10.3389/fimmu.2023.1295257
Emerging phagocytosis checkpoints in cancer immunotherapy.
Liu Y, Liu Y, Wang Y, Yang Y, et al · · 2023 · cited 186× · PMID 36882399 · DOI 10.1038/s41392-023-01365-z
Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
Study and analysis of antitumor resistance mechanism of PD1/PD-L1 immune checkpoint blocker.
Wang Z, Wu X. · · 2020 · cited 147× · PMID 32875727 · DOI 10.1002/cam4.3410
Targeting immune checkpoints in breast cancer: an update of early results.
Solinas C, Gombos A, Latifyan S, Piccart-Gebhart M, et al · · 2017 · cited 122× · PMID 29177095 · DOI 10.1136/esmoopen-2017-000255

Verify or expand the search:

Other trials of RRx-001

Trials testing the same drug.

NCT05966194 — RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer · Phase 2 · recruiting
NCT04525014 — RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and · Phase 1 · terminated
NCT03515538 — Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatme · Phase 2 · completed
NCT02801097 — RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD) · Phase 1 · terminated
NCT02452970 — RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy · Phase 2 · terminated

Other recruiting trials for Malignant Solid Tumor

Currently open trials in the same condition.

NCT06057038 — A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors · Phase 1 · active not recruiting
NCT05629689 — A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tum · Phase 1 · recruiting
NCT05103358 — Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 G · Phase 2 · active not recruiting
NCT05141474 — Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte ( · EARLY_PHASE1 · recruiting
NCT04632108 — A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients · Phase 1, PHASE2 · active not recruiting

Other EpicentRx, Inc. trials

Trials by the same sponsor.

NCT05966194 — RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer · Phase 2 · recruiting
NCT04525014 — RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and · Phase 1 · terminated
NCT05566041 — A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in S · Phase 3 · active not recruiting
NCT04673942 — A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors · Phase 2 · recruiting
NCT03699956 — RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell L · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02518958 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EpicentRx, Inc.
Last refreshed: 18 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02518958.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing