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NCT03693014 · ClinicalTrials.gov registry record · Phase 2
A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inhibitors
A Phase 2 study of Lung Cancer and Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 10
- Study locations
NCT03693014: Active Phase 2 study of Lung Cancer and Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03693014 is a Phase 2 study of Lung Cancer and Bladder Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 69 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03693014, a Phase 2 study of Lung Cancer and Bladder Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 10
- Study locations
Study Summary
Drugs called checkpoint inhibitors help the immune system fight cancer. When the effectiveness of these drugs wears off, it may be possible to renew their effectiveness by combining it with a special type of radiation therapy called stereotactic body radiation therapy (SBRT). SBRT is a commonly used type of radiation therapy that gives high dose radiation with high precision to tumors in 1-5 treatments. Radiation therapy, such as SBRT can also treat sites of metastases. The use of checkpoint inhibitors in combination with SBRT has been suggested to improve the immune response against cancer but has not been tested in a formal clinical trial. Up to three lesions can be treated with SBRT. This study only allows checkpoint inhibitors that are already approved by the Federal Drug Agency (FDA) for the treatment of your disease. All radiation therapy will be done on machines which are FDA approved.
Primary Outcome
in non-irradiated lesions during the first 24 weeks after treatment initiation as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with limited progression receiving hypofractionated radiotherapy. ORR rate is defined as the number of patients treated to a given arm with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of patients.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiotherapy
- BIOLOGICAL Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab
Study Locations (10)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Rockville Centre - Rockville Centre
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Connecticut
- Hartford Healthcare - Hartford
Pennsylvania
- Lehigh Valley Health Network - Allentown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What the registry record for NCT03693014 still lists
NCT03693014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (93% lower).
The record links to 6 conditions, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Body Radiotherapy is the first listed.
NCT03693014 lists 10 locations in 4 states (New York, New Jersey, Connecticut).
Frequently Asked Questions
What is clinical trial NCT03693014 about?
NCT03693014 is a clinical study titled "A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inhibitors". Drugs called checkpoint inhibitors help the immune system fight cancer. When the effectiveness of these drugs wears off, it may be possible to renew their effectiveness by combining it with a special type of radiation therapy called stereotactic body radiation therapy (SBRT). SBRT is a commonly used...
What is the current status of trial NCT03693014?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2018-10-01. Estimated completion is 2026-10.
What conditions does trial NCT03693014 study?
This clinical trial studies the following conditions: Lung Cancer, Bladder Cancer, Metastatic Cancer, Renal Cancer, Melanoma Cancer.
What interventions are being tested in trial NCT03693014?
The interventions under investigation include: Stereotactic Body Radiotherapy (RADIATION), Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03693014?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03693014 being conducted?
This trial has 10 study locations across Connecticut, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03693014's enrollment target sits among peer trials
69 229th of 409 higher than 180 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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