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NCT03474497 · ClinicalTrials.gov registry record · Phase 1
UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade
A Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Megan Daly, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT03474497: Active Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Megan Daly, MD.
NCT03474497 is a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Megan Daly, MD. The registered enrollment target is 18 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03474497, a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Megan Daly, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase I/II study that will evaluate the safety and toxicity of this combinatorial approach. Eligible patients \>18 years of age with histologically proven metastatic NSCLC, melanoma, RCC, or HNSCC who have failed PD-1 / PD-L1 checkpoint blockade therapy will be enrolled. Patients must have a candidate treatment lesion (subcutaneous, nodal, or visceral) accessible and safe for radiotherapy and serial intralesional injections as specified by the protocol. They must also have at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by RECIST. This study will consist of a phase I dose escalation using a standard 3+3 design to determine safety and MTD of intralesional IL-2 which will be dose escalated in conjunction with standard fixed doses of RT and Pembrolizumab. At the MTD there will be a phase II dose expansion which will incorporate a simon-two stage design to assess efficacy and safety. Patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy.
Primary Outcome
To determine the abscopal response rate (ARR) defined as objective response rate (the number of patient that achieve a partial or complete response) at unirradiated sites using irRECIST criteria using imaging obtained every 60 days.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Radiotherapy
- DRUG IL-2
Study Locations (2)
California
- UC Davis Medical Center - Sacramento
- University of California Davis Medical Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2026-02 |
| Phase | Phase 1 |
What the registry record for NCT03474497 still lists
NCT03474497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 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 (97% 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.
NCT03474497 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03474497 about?
NCT03474497 is a clinical study titled "UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade". This is a phase I/II study that will evaluate the safety and toxicity of this combinatorial approach. Eligible patients \>18 years of age with histologically proven metastatic NSCLC, melanoma, RCC, or HNSCC who have failed PD-1 / PD-L1 checkpoint blockade therapy will be enrolled. Patients must have...
What is the current status of trial NCT03474497?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-05-20. Estimated completion is 2026-02.
What conditions does trial NCT03474497 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Metastatic Melanoma, Metastatic Renal Cell Carcinoma.
What interventions are being tested in trial NCT03474497?
The interventions under investigation include: Pembrolizumab (DRUG), Radiotherapy (RADIATION), IL-2 (DRUG).
Who is sponsoring clinical trial NCT03474497?
This trial is sponsored by Megan Daly, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03474497 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03474497's enrollment target sits among peer trials
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