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Oral MucositisPhase 2KEVLARxNCT05966194

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

A Phase 2 study testing RRx-001, Intensity Modulated Radiation Therapy (IMRT) and Cisplatin for injection 100 mg/m2 in people with Oral Mucositis, run by EpicentRx, Inc. at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Mucositis
What is being tested?
RRx-001, Intensity Modulated Radiation Therapy (IMRT) and Cisplatin for injection 100 mg/m2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
14 sitesUnited States
Study dates
2 Apr 2024to 1 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity or oropharynx Note: Patients with primary cancers that are presumed to be of oropharyngeal origin may be included if they meet radiation field dosing criteria as specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are acceptable. HPV determination must be made for all patients.
  • Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to 2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or adjuvant chemotherapy. Planned radiation treatment fields must include at least two oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned to receive a total of > 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
  • ECOG performance status ≤ 2.
  • Participants must have adequate organ and marrow function as defined below:
  • Absolute neutrophil count (ANC) ≥ 1,500 / mm3 2. Platelets ≥ 75,000 / mm3 3. Hemoglobin ≥ 9.0 g/dL
  • Adequate renal and liver function as indicated by:
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  • Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) 2. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 4. Alkaline phosphatase ≤ 2.5 x ULN
  • Human papilloma virus (HPV) status in tumor must be documented using tumor immunohistochemistry for HPV-p16 or other accepted test (such as such as in situ hybridization) for patients with cancers of the oropharynx (Rooper et al, 2016, Martens 2017). HPV status at baseline optional for oral cavity tumors.
  • Age 18 years or older
  • Patient must consent to the access, review, and analysis of previous medical and cancer history, including imaging data, by the sponsor or a third party nominated by the sponsor.
  • Ability and willingness to understand and sign a written informed consent document.
  • Women of childbearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
  • Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been postmenopausal for at least 12 consecutive months
  • Adequate visual access to permit examination of the following oral cavity sites: lips, buccal mucosa, floor of mouth, ventral and lateral tongue, and soft palate.

Who cannot join

  • Prior radiotherapy to the head and neck region.
  • Prior induction chemotherapy.
  • Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
  • Patients with simultaneous primaries
  • Stage IV, M1 (distant metastasis)
  • Prior or current use of approved or investigational anticancer agent other than those provided in this study.
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  • Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal (solid) diet
  • Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason or prophylactic insertion of gastrostomy tube with dependency on tube feeding at baseline.
  • Malignant tumors other than squamous cell carcinoma of the head and neck within last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator.
  • Active infectious disease excluding oral candidiasis.
  • Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at baseline.
  • Untreated active oral or dental infection
  • Known history of human immunodeficiency virus or active hepatitis B or C.
  • Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (e.g, immunosuppression, uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema)
  • Use of the following within 48 hours of enrollment and duration of Oral Mucositis follow up: vitamin B12 (cobalamin) or synthetic vitamin B12, cyanocobalamin, or the vitamin B12 precursor, cobinamide, or any supplement or multivitamin with vitamin B12 or vitamin E in it since both vitamin B12 and vitamin E interact negatively with RRx-001.
  • Use of prebiotics and probiotics
  • Pregnant or nursing.
  • Known allergies or intolerance to cisplatin or other platinum-containing compounds.
  • Sjogren syndrome

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Sandra and Malcolm Berman Cancer Institute

    Baltimore, Maryland, 21204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The Ohio State University James Cancer Hospital & Solove Research Institute

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Parkview Cancer Institute

    Fort Wayne, Indiana, 46845

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27834

  • Ballad Health

    Johnson City, Tennessee, 37604

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Willis Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

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.

Read the detailed description

The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there is only one approved therapy to treat or prevent it.

Conditions
Oral Mucositis
Being tested
RRx-001, Intensity Modulated Radiation Therapy (IMRT), Cisplatin for injection 100 mg/m2
Keywords
Head and Neck Cancer, Neck cancer, Oral cancer, Mucositis, Squamous cell carcinoma (SCC), HPV, Oropharynx, Oral cavity, IMRT
Medical subject headings
Stomatitis, Head and Neck Neoplasms, Mouth Neoplasms, Mucositis, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RRx-001Drug

    RRx-001 for injection (4 mg or 8 mg)

  • Intensity Modulated Radiation Therapy (IMRT)Radiation

    Intensity Modulated Radiation Therapy of up to 72 Gy

  • Cisplatin for injection 100 mg/m2Drug

    Cisplatin for injection 100 mg/m2

Study groups in NCT05966194
Study groupRoleWhat they receive
RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)ExperimentalPretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period
Receives: Drug: RRx-001; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin for injection 100 mg/m2
RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)ExperimentalPretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period.
Receives: Drug: RRx-001; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin for injection 100 mg/m2
Placebo Pre-Treatment + Chemoradiation Therapy (CRT)Placebo comparatorNo doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period.
Receives: Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin for injection 100 mg/m2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)

    The incidence of SOM defined as the proportion of patients with any WHO Grade >= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through IMRT

    Measured: Estimated up to 18 Months

Secondary outcomes (13)

  1. Duration of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)

    Duration of SOM (through the last day of radiation therapy, DoSOM). Its principal analysis employs the probability of being in response (PBIR), an intuitive concept based on the realization that the duration of response which is quantified as the area under the curve delimited by the duration of exposure (x axis) and the response probability (y axis).

    Measured: Estimated up to 18 Months

  2. Duration of Severe Oral Mucositis (SOM) through 60 Gy

    Duration of SOM (through 60 Gy, DoSOM) is compared between RRx-001 arms and Placebo using a two-sided log-rank test.

    Measured: Estimated up to 18 Months

  3. Time to onset of Sever Oral Mucositis (ttSOM)

    Time onset to SOM (ttSOM) is defined as the time interval measured from the start of the observation period to the first time SOM is observed.

    Measured: Estimated up to 18 Months

  4. Incidence and severity of dysphagia

    Incidence and severity of dysphagia will be analyzed similarly to the primary efficacy endpoint.

    Measured: Estimated up to 18 Months

  5. Cumulative radiation dose to onset of SOM

    Cumulative radiation dose to onset of SOM is compared between RRx-001 arms and placebo

    Measured: Estimated up to 18 Months

  6. Incidence of grade 4 oral mucositis

    Incidence of grade 4 oral mucositis through 60 Gy

    Measured: Estimated up to 18 Months

  7. Narcotic use through resolution of SOM

    Narcotic use through resolution of SOM will be analyzed similarly to the cumulative radiation dose

    Measured: Estimated up to 18 Months

  8. Incidence of Severe Oral Mucositis through 60 Gy of the Radiation Treatment Plan

    incidence of SOM defined as the proportion of patients with any WHO Grade >= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through 60 Gy

    Measured: Estimated up to 18 Months

  9. Progression free survival (PFS)

    Progression free survival (PFS)

    Measured: Estimated up to 24 Months

  10. Degree of Xerostomia

    Degree of Xerostomia as analyzed by validated Xerostomia questionnaire 'XQ'

    Measured: Estimated up to 24 Months

  11. Xerostomia duration

    Xerostomia duration as analyzed by validated Xerostomia questionnaire 'XQ'

    Measured: Estimated up to 24 Months

  12. Time to onset of dysphagia

    Time to onset of dysphagia

    Measured: Estimated up to 24 Months

  13. Duration of dysphagia

    Duration of dysphagia

    Measured: Estimated up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start2 Apr 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05966194
Sponsor's protocol ID
K-01
Acronym
KEVLARx
Status last verified
Jun 2026
First submitted
21 Jul 2023
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bonomi M, Blakaj DM, Kabarriti R, Colvett K, Takiar V, Biagioli M, Bar-Ad V, Goyal S, Muzyka B, Niermann K, Abrouk N, Oronsky B, Reid T, Caroen S, Sonis S, Sher DJ. PREVLAR: Phase 2a Randomized Trial to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Head and Neck Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):551-559. doi: 10.1016/j.ijrobp.2022.12.031. Epub 2023 Jan 14.

    PubMed 36646388

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RRx-001, Intensity Modulated Radiation Therapy (IMRT) and Cisplatin for injection 100 mg/m2 in people with Oral Mucositis, run by EpicentRx, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT) (time frame: Estimated up to 18 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05966194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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