A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers

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 objec

Trial Details

NCT ID
NCT05893888
Phase
PHASE2 / PHASE3
Sponsor
Privo Technologies
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • PRV211 (Intraoperative Cisplatin System)
  • PRV111 (Cisplatin Transmucosal System)
  • PRV131 (Cisplatin Intratumoral Injectable)
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Miami, Florida, United States|25.77427,-80.19366
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Cleveland, Ohio, United States|41.4995,-81.69541

Key Eligibility Criteria

  • 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 confi…
  • Criteria for Inclusion for both ARM 1 \& ARM 2:
  • Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention

For full eligibility, visit ClinicalTrials.gov.

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