Trial · NCT05893888
A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
NCT05893888, Phase 2, Phase 3, Recruiting, Privo Technologies
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers. Trials, record NCT05893888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05893888
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
- NCT number
- NCT05893888
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Privo Technologies
- Conditions
- Oral Squamous Cell Carcinoma
- Interventions
- PRV211 (Intraoperative Cisplatin System), PRV111 (Cisplatin Transmucosal System), PRV131 (Cisplatin Intratumoral Injectable)
- First posted
- 2023-06-08
- Last updated
- 2026-04-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 6-7 months | Proportion of treated tumors that have a response to PRV111 treatment. Response is defined as either or both: 1) histopathological downgrade of the disease such as partial or complete response as determined by post-treatment biopsies compared to baseline, or 2) clinically measurable tumor volume reduction from baseline of 30% or more from baseline. |
| Primary | Safety assessed via dose-limiting toxicities | 1-month post-surgery and through study completion, ~12-14 months | Determine a safe dose of PRV211 (Intraoperative Cisplatin System) under the conditions of the trial. For the purpose of safety detection, if greater than 33% of subjects being evaluated for safety present with dose-limiting toxicities (DLTs), the study drug is deemed unsafe. |
| Secondary | Event Free Survival | through study completion, ~12-14 months | An event is defined as: salvage surgery, locoregional recurrence at 12 months or death due to any cause. |
| Secondary | Pharmacokinetics: platinum levels in blood | through study completion, ~12-14 months | whole blood samples will be taken to quantify the amount of cisplatin present. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R44CA272095 | Clinical Studies for Improving Survival Rates for Oral Cancer Patients in Low Resource Settings | GOLDBERG, MANIJEH N; KEITH, DONNA | PRIVO TECHNOLOGIES, LLC | NATIONAL CANCER INSTITUTE | 2022 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05893888
GET https://conductscience.org/api/trials/v1/NCT05893888/registered