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NCT03647163 · ClinicalTrials.gov registry record · Phase 1
Ph I/II Trial of Systemic VSV-IFNβ-NIS in Combination With Checkpoint Inhibitor Therapy in Patients With Select Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by Vyriad.
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 2
- Study locations
NCT03647163: Active Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by Vyriad.
NCT03647163 is a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor that is active but no longer recruiting, run by Vyriad. The registered enrollment target is 33 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03647163, a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, is active but no longer recruiting, sponsored by Vyriad.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 2
- Study locations
Study Summary
The safety run-in portion of this study is designed to identify the optimal dose of VSV-IFNβ-NIS in combination with pembrolizumab in patients with solid tumors and follows the 3+3 design. The expansion portion will use one-sample binomial designs to assess the efficacy of the combination in patients with refractory NSCLC or NEC. The optimal dose (RP2D) determined in the dose escalation portion of the trial will be used for the expansion portion. The study has been conducted with a dose of 1.7 × 1010 as the recommended phase II dose in an expansion cohort of 10 patients with NSCLC. However, current data suggests that VSV-IFNβ-NIS doses of up to 1.7 × 1011 is safe and likely more efficacious. Thus, this study will test a second VSV-IFNβ-NIS dose level, 1.0x1011 TCID50. A safety assessment will be carried out after 3 patients are enrolled. If this dose schedule is well tolerated and virus PK are not negatively impacted, both the NSCLC and NEC expansion cohorts will open using this dose schedule. If 2 of the first 3 patients or 2 of the first 6 patients experience a DLT, the dose will be de-escalated to 5 x 1010. The safety run-in/dose escalation portion of this study is expected to require a minimum of 3 patients and a maximum of 18 patients (6 patients per dose level). The expansion portion of this study is expected to require a minimum of 10 per cohort. The NSCLC and NEC patients enrolled at the identified optimal dose in the dose escalation cohort would be included in the dose expansion cohort if they are evaluable for the primary endpoint in the expansion portion (4 dose escalation patients at the optimal dose are expected to roll over to the expansion). Additionally, up to 16 Renal Cell Carcinoma (RCC) patients will be treated in the expansion cohort. This will permit up to 86 treated patients.
Primary Outcome
proportion of patients in the analysis population who have complete response (CR) or partial response (PR) based on RECIST 1.1 imaging
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL VSV-IFNβ-NIS
- BIOLOGICAL ipilimumab + nivolumab
Study Locations (2)
Minnesota
- Mayo Clinic - Rochester
Ohio
- Cleveland Clinic Taussig Cancer Institute - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-04-09 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 1 |
What the registry record for NCT03647163 still lists
NCT03647163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03647163 reports a single indexed study location in Minnesota, Ohio.
Frequently Asked Questions
What is clinical trial NCT03647163 about?
NCT03647163 is a clinical study titled "Ph I/II Trial of Systemic VSV-IFNβ-NIS in Combination With Checkpoint Inhibitor Therapy in Patients With Select Solid Tumors". The safety run-in portion of this study is designed to identify the optimal dose of VSV-IFNβ-NIS in combination with pembrolizumab in patients with solid tumors and follows the 3+3 design. The expansion portion will use one-sample binomial designs to assess the efficacy of the combination in patient...
What is the current status of trial NCT03647163?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2019-04-09. Estimated completion is 2025-09-30.
What conditions does trial NCT03647163 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Solid Tumor, Neuroendocrine Carcinoma, Renal Cell Carcinoma (RCC).
What interventions are being tested in trial NCT03647163?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), VSV-IFNβ-NIS (BIOLOGICAL), ipilimumab + nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03647163?
This trial is sponsored by Vyriad, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03647163 being conducted?
This trial has 2 study locations across Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03647163's enrollment target sits among peer trials
33 383rd of 454 higher than 71 of 454 other Non-Small Cell Lung Cancer trials
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