Oral Cavity Squamous Cell CarcinomaPhase 1/2NCT06097468
Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)
A Phase 1/2 study testing NisinZ® P in people with Oral Cavity Squamous Cell Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a study of oral nisin administration in patients with OSCC who are undergoing complete surgical resection surgery with or without adjuvant radiation/chemoradiation as part of their routine care at the University of California, San Francisco (UCSF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- NisinZ® P
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 1 Oct 2028
- Phase
- Phase 1/2
- 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
- Participants with a suspected clinical diagnosis of oral cavity squamous cell carcinoma (OSCC) who are planning to undergo a diagnostic biopsy. Note: Subsequent documentation from the medical record (e.g., from the diagnostic biopsy pathology report) of histological or cytological confirmation of OSCC is required prior to enrollment and treatment on study. Participants who do not have a histological/cytological confirmation of OSCC, or who are unable to provide sufficient volume of biopsy tissue for research, will not be eligible to enroll in the study.
- OSCC mass must be >= 2cm in size.
- Non-metastatic OSCC (no distant metastases allowed; metastasis to the neck is eligible).
- Participants must be planning for a complete OSCC surgical resection, with or without adjuvant radiation/chemoradiation, at UCSF, as part of their routine treatment plan. Surgical resection and adjuvant treatment will be according to the participants routine or standard of care treatment plan and will not be dictated by the study (non-interventional).
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%).
- Participants must be dentate (retaining at least two teeth). Teeth are required for plaque sample collection for correlative studies.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Individuals with a history of a known positive human papillomavirus deoxyribonucleic acid ((HPV DNA) test (P16-positive is permitted if HPV DNA test is negative).
- Individuals with a history of or concurrent oropharyngeal, laryngeal, or hypopharyngeal cancers (other than OSCC). Individuals with any other prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
- Individuals with ongoing uncorrected oral pathology, which in the opinion of the investigator could interfere with the safety or endpoints of this study or could be exacerbated during the course of study participation, if left untreated. These conditions may be discussed with the study PI to determine eligibility.
- Current and ongoing long-term dental treatment requiring major surgery;
- Untreated carious lesions, severe oral infections, or known defective restorations;
- Other suspicious uncorrected oral pathology.
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- Individuals with a known history of hypersensitivity reactions or oral allergies to nisin, any of its excipients, or any related food preservatives.
- Individuals with complete inability to absorb nutrients via gastrointestinal tract due to major medical disorder or history of gastrointestinal surgical removal.
- Individuals who have received extended (>4 weeks) antibiotic therapy within 1 month of the baseline visit or who currently require continuous antibiotic prophylaxis at the time of enrollment.
- Individuals who require treatment with a systemic anticancer therapy prior to enrollment, with the exception of prior immunotherapy which is permitted both prior to enrollment and concurrent with study participation.
- Individuals currently receiving any other investigational agent or using an investigational device intended as anticancer therapy, with the exception of investigational immunotherapy, which is permitted both prior to enrollment and concurrent with study participation.
- Individuals with ongoing Grade 2 events that are not clinically stable or ongoing >= Grade 3 events (CTCAE v5.0 grading).
- Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities, interfere with participant safety, or study endpoints.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Narimane Badawi, (415) 866-7594, Narimane.Badawi@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: A Phase I/IIa, Single-Arm, Dose-Confirmation and Dose-Expansion Study Evaluating Changes in the Oral Microbiome of Patients With Oral Cavity Squamous Cell Carcinoma (OSCC) After Short-Term Ingestion of Nisin, a Naturally Occurring Food Preservative
This is a study of oral nisin administration in patients with OSCC who are undergoing complete surgical resection surgery with or without adjuvant radiation/chemoradiation as part of their routine care at the University of California, San Francisco (UCSF).
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate the tolerability of nisin administration, as assessed by the maximum tolerated dose (MTD) of nisin (Phase I).
II. To demonstrate the feasibility of nisin administration, as assessed by the treatment completion rate (Phase IIa).
SECONDARY OBJECTIVES:
- To evaluate the safety of nisin administration, as assessed by the frequency and severity of adverse events (CTCAE v5.0) (Phase I).
II. To evaluate externally measured changes in primary and nodal tumor size on intraoral examination from baseline to time of surgery, as assessed by cross-sectional measurement of tumors/ulceration with calipers during dental exam (Phase IIa).
III. To evaluate clinical changes in periodontal condition on dental examination over the study period, as assessed according to the American Academy of Periodontology grading system (Phase IIa).
EXPLORATORY OBJECTIVES:
- To characterize nisin-induced changes in oral microbiome population structure and function, and nisin sensitivity among key oral bacterial species.
II. To characterize inflammatory and anti-tumor cellular responses to nisin in the oral cancer environment.
III. To confirm the half-life and urinary excretion profile of nisin (Phase 1).
IV. To demonstrate the preliminary efficacy of nisin administration, as assessed by relapse-free survival (RFS) and overall survival (OS) (Phase IIa).
OUTLINE:
Participants receiving treatment at UCSF will be initially assigned to the Phase 1 dose finding arm. After an interim analysis is completed, enrollment into Phase IIa will begin at the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D). Participants will be treated for two weeks before planned surgery, complete OSCC resection surgery (standard of care, non-interventional) and will continue treatment for 6 additional months post-surgery. Follow-up will continue for 12 months after surgery.
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Being tested
- NisinZ® P, Surgery (non-interventional, standard of care)
- Keywords
- Oral Microbiome, Natural Food Preservative
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NisinZ® PDrug
Also called Nisin Z, Nisin Z concentrate, Ultrapure Nisin Z concentrate
NisinZ® P is an ultrapure Nisin Z concentrate produced by fermentation using the bacterium Lactococcus lactis obtained from sauerkraut
Surgery (non-interventional, standard of care)Procedure or surgery
Also called Surgical resection
Surgical removal of tumor as part of standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Dose Finding - Starting Dose (20,000 mg) | Experimental | Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The starting dose level, with dose modification permitted for toxicity management or intolerability will be 20,000 mg (2 x 10 g bottles) per day. Receives: Drug: NisinZ® P; Procedure: Surgery (non-interventional, standard of care) |
| Phase IIa, Dose Expansion (MTD/RP2D) | Experimental | Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The dose level will be determined by the outcomes in Phase 1 (RP2D), with dose modification permitted for toxicity management or intolerability. Receives: Drug: NisinZ® P; Procedure: Surgery (non-interventional, standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with dose limiting toxicities (DLT) (Phase I)
Dose-limiting toxicities (DLTs) are defined in Section 5.2.3. DLT determination will assess adverse events (AEs) graded according to CTCAE v5.0, including findings on physical exam, vital signs, laboratory testing, and spontaneous reports of AEs reported to the investigator by participants. DLT data will be summarized as proportions of participants experiencing DLTs per cohort
Measured: Up to 6 months
Maximum Tolerated Dose / Recommended Phase II Dose (RP2D) (Phase I)
The maximum tolerated dose (MTD) is the highest dose at which no more than one instance of DLT is observed among 6 participants treated. The MTD from Phase I will be the recommended Phase IIa dose (RP2D) for use in Phase IIa.
Measured: Up to 4 weeks
Proportion of participants completing treatment (Phase II)
The treatment completion rate is defined as the proportion of participants allocated to receive nisin at the RP2D and who complete the full nisin regimen, missing fewer than 30% of doses over the course of the regimen. A full nisin regimen is defined as starting nisin 2 weeks before surgery and continuing for 6 months after surgery.
Measured: Up to 6 months
Secondary outcomes (5)
Incidence of Treatment-emergent adverse events (AE)
Safety will be assessed by monitoring adverse events (AEs), including Grade >=3 intraoral mucositis. AEs will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. AEs will be evaluated up to 60 days after treatment discontinuation.
Measured: Up to 8 months
Mean change in dimensional measurement of ulcerations over time
Mean change in cross-sectional, dimensional measurement of tumors/ulcerations from baseline to post-surgery will be measured with calipers during a dental exam and reported by cohort.
Measured: Up to 6 months
Proportion of participants with changes in periodontal pocket depth
Clinical changes in periodontal pocket depth on dental examination over the study period will be assessed according to the American Academy of Periodontology grading system.
Measured: Up to 6 months
Proportion of participants with changes in periodontal clinical detachment loss
Clinical changes in clinical detachment loss on dental examination over the study period will be assessed according to the American Academy of Periodontology grading system.
Measured: Up to 6 months
Proportion of participants with changes in periodontal bleeding
Clinical changes in bleeding upon probing at 6 sites per tooth on dental examination over the study period will be assessed according to the American Academy of Periodontology grading system.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start2 Feb 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sue Yom, MD, Principal investigator, University of California, San FranciscoYvonne Kapila, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097468
- Sponsor's protocol ID
- 23203
- Other IDs
- NCI-2023-08852, R01CA269950-04
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Single-Arm, Dose-Confirmation and Dose-Expansion Study Evaluating Changes in the Oral Microbiome of Patients With Oral Cavity Squamous Cell Carcinoma (OSCC) After Short-Term Ingestion of Nisin, a Naturally Occurring Food Preservative
- ClinicalTrials.gov ID
- NCT06097468
- Acronym / sponsor ID
- 23203
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Keywords
- Oral Microbiome, Natural Food Preservative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Cancer Institute (NCI)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of oral nisin administration in patients with OSCC who are undergoing complete surgical resection surgery with or without adjuvant radiation/chemoradiation as part of their routine care at the University of California, San Francisco (UCSF).
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate the tolerability of nisin administration, as assessed by the maximum tolerated dose (MTD) of nisin (Phase I).
II. To demonstrate the feasibility of nisin administration, as assessed by the treatment completion rate (Phase IIa).
SECONDARY OBJECTIVES:
- To evaluate the safety of nisin administration, as assessed by the frequency and severity of adverse events (CTCAE v5.0) (Phase I).
II. To evaluate externally measured changes in primary and nodal tumor size on intraoral examination from baseline to time of surgery, as assessed by cross-sectional measurement of tumors/ulceration with calipers during dental exam (Phase IIa).
III. To evaluate clinical changes in periodontal condition on dental examination over the study period, as assessed according to the American Academy of Periodontology grading system (Phase IIa).
EXPLORATORY OBJECTIVES:
- To characterize nisin-induced changes in oral microbiome population structure and function, and nisin sensitivity among key oral bacterial species.
II. To characterize inflammatory and anti-tumor cellular responses to nisin in the oral cancer environment.
III. To confirm the half-life and urinary excretion profile of nisin (Phase 1).
IV. To demonstrate the preliminary efficacy of nisin administration, as assessed by relapse-free survival (RFS) and overall survival (OS) (Phase IIa).
OUTLINE:
Participants receiving treatment at UCSF will be initially assigned to the Phase 1 dose finding arm. After an interim analysis is completed, enrollment into Phase IIa will begin at the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D). Participants will be treated for two weeks before planned surgery, complete OSCC resection surgery (standard of care, non-interventional) and will continue treatment for 6 additional months post-surgery. Follow-up will continue for 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I, Dose Finding - Starting Dose (20,000 mg) | Experimental | Drug: NisinZ® P, Procedure: Surgery (non-interventional, standard of care)Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The starting dose level, with dose modification permitted for toxicity management or intolerability will be 20,000 mg (2 x 10 g bottles) per day. |
| Phase IIa, Dose Expansion (MTD/RP2D) | Experimental | Drug: NisinZ® P, Procedure: Surgery (non-interventional, standard of care)Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The dose level will be determined by the outcomes in Phase 1 (RP2D), with dose modification permitted for toxicity management or intolerability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with a suspected clinical diagnosis of oral cavity squamous cell carcinoma (OSCC) who are planning to undergo a diagnostic biopsy. Note: Subsequent documentation from the medical record (e.g., from the diagnostic biopsy pathology report) of histological or cytological confirmation of OSCC is required prior to enrollment and treatment on study. Participants who do not have a histological/cytological confirmation of OSCC, or who are unable to provide sufficient volume of biopsy tissue for research, will not be eligible to enroll in the study.
- OSCC mass must be >= 2cm in size.
- Non-metastatic OSCC (no distant metastases allowed; metastasis to the neck is eligible).
- Participants must be planning for a complete OSCC surgical resection, with or without adjuvant radiation/chemoradiation, at UCSF, as part of their routine treatment plan. Surgical resection and adjuvant treatment will be according to the participants routine or standard of care treatment plan and will not be dictated by the study (non-interventional).
- Age >= 18 years
Key exclusion criteria (13 listed)
- Individuals with a history of a known positive human papillomavirus deoxyribonucleic acid ((HPV DNA) test (P16-positive is permitted if HPV DNA test is negative).
- Individuals with a history of or concurrent oropharyngeal, laryngeal, or hypopharyngeal cancers (other than OSCC). Individuals with any other prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
- Individuals with ongoing uncorrected oral pathology, which in the opinion of the investigator could interfere with the safety or endpoints of this study or could be exacerbated during the course of study participation, if left untreated. These conditions may be discussed with the study PI to determine eligibility.
- Individuals with a known history of hypersensitivity reactions or oral allergies to nisin, any of its excipients, or any related food preservatives.
- Individuals with complete inability to absorb nutrients via gastrointestinal tract due to major medical disorder or history of gastrointestinal surgical removal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NisinZ® PAlso: Nisin Z, Nisin Z concentrate, Ultrapure Nisin Z concentrateNisinZ® P is an ultrapure Nisin Z concentrate produced by fermentation using the bacterium Lactococcus lactis obtained from sauerkraut | Drug | Phase I, Dose Finding - Starting Dose (20,000 mg), Phase IIa, Dose Expansion (MTD/RP2D) |
| Surgery (non-interventional, standard of care)Also: Surgical resectionSurgical removal of tumor as part of standard of care treatment | Procedure or surgery | Phase I, Dose Finding - Starting Dose (20,000 mg), Phase IIa, Dose Expansion (MTD/RP2D) |
Primary outcome
Proportion of participants with dose limiting toxicities (DLT) (Phase I)
Time frame: Up to 6 months
Dose-limiting toxicities (DLTs) are defined in Section 5.2.3. DLT determination will assess adverse events (AEs) graded according to CTCAE v5.0, including findings on physical exam, vital signs, laboratory testing, and spontaneous reports of AEs reported to the investigator by participants. DLT data will be summarized as proportions of participants experiencing DLTs per cohort
Maximum Tolerated Dose / Recommended Phase II Dose (RP2D) (Phase I)
Time frame: Up to 4 weeks
The maximum tolerated dose (MTD) is the highest dose at which no more than one instance of DLT is observed among 6 participants treated. The MTD from Phase I will be the recommended Phase IIa dose (RP2D) for use in Phase IIa.
Proportion of participants completing treatment (Phase II)
Time frame: Up to 6 months
The treatment completion rate is defined as the proportion of participants allocated to receive nisin at the RP2D and who complete the full nisin regimen, missing fewer than 30% of doses over the course of the regimen. A full nisin regimen is defined as starting nisin 2 weeks before surgery and continuing for 6 months after surgery.
5 secondary outcomes
Incidence of Treatment-emergent adverse events (AE)
Time frame: Up to 8 months
Mean change in dimensional measurement of ulcerations over time
Time frame: Up to 6 months
Proportion of participants with changes in periodontal pocket depth
Time frame: Up to 6 months
Proportion of participants with changes in periodontal clinical detachment loss
Time frame: Up to 6 months
Proportion of participants with changes in periodontal bleeding
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue Yom, MD principal investigator
University of California, San Francisco
Yvonne Kapila, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NisinZ® P in people with Oral Cavity Squamous Cell Carcinoma, run by University of California, San Francisco at 1 site 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Narimane Badawi ((415) 866-7594, Narimane.Badawi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with dose limiting toxicities (DLT) (Phase I) (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.