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Tests treatment safety and results for Oral Squamous Cell Carcinoma
Official title A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
ClinicalTrials.gov ID: NCT05893888
What this study is testing
What is PRV211 (Intraoperative Cisplatin System)?
PRV211 (Intraoperative Cisplatin System) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for oral squamous cell carcinoma.
Also referred to as Cisplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Arm 1 ( Phase 2/3 Run in ): PRV111: Topical Locoregional Delivery Placed Over the Tumor Region Primary Endpoint: Overall Response Rate (ORR) Primary Objective: Demonstrate the safety and efficacy of PRV111 in patients with Carcinoma in Situ (CIS) (WHO 2017) Arm 2 (Phase 1) PRV211: Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting Arm 3 (Phase 1/2) PRV131: Intratumoral Injectable delivery into the Tumor Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable Subject Assignment: Subjects will be assigned to Arm 1, Arm 2, or Arm 3 of this study based on disease staging Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-1, M0 Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-2, N0, M0
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Different diagnosis for ARM 1 \& ARM 2, however the rest of are the same for both arms: In order to be eligible to participate in the study, an...
- Diagnosis Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity Arm 2: Pathologically proven and clinically...
- Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention
- Adult people, men and women, defined by age ≥18 years at the time of screening.
- Tumor must be accessible, with no evidence of infection or active bleeding.
You likely can't join if
- Participants meeting any of the following criteria will be excluded from the study:
- Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.
- Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.
- Cardiac Function: Corrected QT interval (QTc) \> 470 ms for women and \> 450 ms for men.
- Bone Involvement: Known bone involvement by the tumor (Stage T4).
- Other Cancers: Diagnosis of salivary gland cancer.
See the full eligibility criteria
Who can join
- Different diagnosis for ARM 1 \& ARM 2, however the rest of are the same for both arms: In order to be eligible to participate in the study, an individual must meet all of the following criteria:
- Diagnosis Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx,M0 of the lip or oral cavity Criteria for Inclusion for...
- Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention
- Adult people, men and women, defined by age ≥18 years at the time of screening.
- Tumor must be accessible, with no evidence of infection or active bleeding.
- Tumor is amenable to surgical resection within 8 weeks of screening visit (Visit 0).
- Clinically and/or radiologically measurable tumor.
- Eastern Collaborative Oncology Group Performance Status of ≤2.
- Male and female people of childbearing potential must agree to use 2 methods of effective contraception from screening and for at least 30 days after the final dose of investigational product. Appropriate birth control...
- Absence of any serious underlying medical conditions which could impair the ability of the subject to participate in the study.
- Have a life expectancy of ≥3 months.
- Willing and able to provide written informed consent.
- Able to return to study site for treatment and follow-up visits as defined in the Protocol. Criteria for Exclusion for both ARM 1 and ARM 2 (unless specified): An individual who meets any of the following criteria will...
- people that are not eligible for surgery as SOC.
- Patients with a prior history of invasive squamous cell carcinoma (Arm 1 only)
- Tumors involving the marginal gingiva (Arm 1 only)
- Squamous cell carcinoma (SCC) of the oral cavity that received previous radiotherapy.(Arm 1 only)
- Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to Screening (Arm 1 only)
- Concurrent documented malignancy, with the exception of localized SCCs and basal cell carcinoma of the skin Exposure to any investigational agent within 3 months prior to Screening
- Known allergy or hypersensitivity to platinum-containing agents, or known intolerance to a prior platinum- containing agent, or to any of the excipients, which, in the judgement of the physician will preclude re-...
- Active, uncontrolled infection requiring systemic therapy, such as but not limited to HIV, Syphilis, Hepatitis B, or Hepatitis C
- Uncontrolled intercurrent illness that would risk subject safety, interfere with the objectives of the Protocol, or limit subject compliance with study requirements, as determined by the Investigator
- Known or suspected pregnancy, planned pregnancy, or lactation
- Any medical or psychiatric condition that may compromise the ability to give written informed consent
- Known diagnosis of oral submucous fibrosis (Arm 1 only)
- Known diagnosis of trismus (Arm 1 only) Arm 3a: Participants must meet all the following criteria to be eligible for the study:
- Age: 18 years or older at the time of screening.
- Diagnosis: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-N1, M0. This includes SCC of the lip with a significant mucosal component.
- Tumor Accessibility: Tumor must be accessible for intratumoral injection, with no evidence of active infection.
- Measurable Disease: Presence of clinically and/or radiologically measurable tumor.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Life Expectancy: Estimated life expectancy of at least 3 months.
- Informed Consent: Ability and willingness to provide written informed consent.
- Compliance: Ability to return to the study site for treatment visits as defined in the protocol.
- Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period.
What rules you out
- Participants meeting any of the following criteria will be excluded from the study:
- Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.
- Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.
- Cardiac Function: Corrected QT interval (QTc) \> 470 ms for women and \> 450 ms for men.
- Bone Involvement: Known bone involvement by the tumor (Stage T4).
- Other Cancers: Diagnosis of salivary gland cancer.
- Prior Treatments: History of oral cancers that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months.
- Multifocal Disease: Presence of multifocal invasive oral squamous cell carcinoma (OSCC).
- Investigational Agents: Exposure to any investigational agent within 3 months prior to screening.
- Allergies: Known allergy or hypersensitivity to platinum-containing agents or any excipients in the study drug, or known intolerance to prior platinum-based therapy that would preclude re-exposure.
- Infections: Active, uncontrolled infections requiring systemic therapy, including but not limited to HIV, syphilis, hepatitis B, or hepatitis C.
- Comorbid Conditions: Uncontrolled intercurrent illness that would pose a risk to subject safety, interfere with study objectives, or limit compliance, as determined by the investigator.
- Pregnancy and Lactation: Known or suspected pregnancy, planned pregnancy, or current lactation.
- Consent Capacity: Any medical or psychiatric condition that may compromise the ability to provide written informed consent. 3b: Inclusion Criteria Participants must meet all the following criteria to be eligible for the...
- Age: 18 years or older at the time of screening.
- Diagnosis: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-T2, N0, M0.
- Tumor Accessibility: Tumor must be accessible for intratumoral injections via a bronchoscope, with no evidence of active infection.
- Measurable Disease: Presence of clinically and/or radiologically measurable tumor.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Life Expectancy: Estimated life expectancy of at least 3 months.
- Informed Consent: Ability and willingness to provide written informed consent.
- Compliance: Ability to return to the study site for treatment visits as defined in the protocol.
- Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period. Exclusion Criteria Participants meeting any of the following criteria will be...
- Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.
- Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.
- Cardiac Function: Corrected QT interval (QTc) \> 470 ms for women and \> 450 ms for men.
- Bone Involvement: Known bone involvement by the tumor (Stage T4).
- Other Cancers: Active concurrent malignancies that require systemic therapy.
- Prior Treatments: History of cancers in the lung that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months.
- Investigational Agents: Exposure to any investigational agent within 3 months prior to screening.
- Allergies: Known allergy or hypersensitivity to platinum-containing agents or any excipients in the study drug or known intolerance to prior platinum-based therapy that would preclude re-exposure.
- Infections: Active, uncontrolled infections requiring systemic therapy, including but not limited to HIV, syphilis, hepatitis B, or hepatitis C.
- Comorbid Conditions: Uncontrolled intercurrent illness that would pose a risk to subject safety, interfere with study objectives, or limit compliance, as determined by the investigator.
- Pregnancy and Lactation: Known or suspected pregnancy, planned pregnancy, or current lactation.
- Consent Capacity: Any medical or psychiatric condition that may compromise the ability to provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Miami, Florida, United States; Chicago, Illinois, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.