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OncoMatch/Clinical Trials/NCT05966194

RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

Is NCT05966194 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including RRx-001 and Cisplatin for for oral mucositis.

Phase 2RecruitingEpicentRx, Inc.NCT05966194Data as of May 2026

Treatment: RRx-001 · Cisplatin for — The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.

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Extracted eligibility criteria

Biomarker criteria

Required: HPV status documented

HPV determination must be made for all patients. HPV status in tumor must be documented using tumor immunohistochemistry for HPV-p16 or other accepted test (such as in situ hybridization) for patients with cancers of the oropharynx. HPV status at baseline optional for oral cavity tumors.

Disease stage

Excluded: Stage IV, M1

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: radiation therapy

Prior radiotherapy to the head and neck region

Cannot have received: induction chemotherapy

Prior induction chemotherapy

Cannot have received: approved or investigational anticancer agent

Exception: other than those provided in this study

Prior or current use of approved or investigational anticancer agent other than those provided in this study

Lab requirements

Blood counts

ANC ≥ 1,500 / mm3; Platelets ≥ 75,000 / mm3; Hemoglobin ≥ 9.0 g/dL

Kidney function

Serum creatinine acceptable for treatment with cisplatin per institutional guidelines

Liver function

Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 3.0 x ULN; Alkaline phosphatase ≤ 2.5 x ULN

Adequate organ and marrow function as defined below: ANC ≥ 1,500 / mm3; Platelets ≥ 75,000 / mm3; Hemoglobin ≥ 9.0 g/dL. Adequate renal and liver function as indicated by: Serum creatinine acceptable for treatment with cisplatin per institutional guidelines; Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 3.0 x ULN; Alkaline phosphatase ≤ 2.5 x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • The University of Arizona Cancer Center · Tucson, Arizona
  • Miami Cancer Institute · Miami, Florida
  • Northwestern University Feinberg School of Medicine · Chicago, Illinois
  • Parkview Cancer Institute · Fort Wayne, Indiana

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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