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NCT02407171 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Combination of MK-3475 and Sterotactic Body Radiotherapy in Patients With Metastatic Melanoma or NSCLC
A Phase 1 study of Lung Cancer and Melanoma, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT02407171: Completed Phase 1 study of Lung Cancer and Melanoma, sponsored by Yale University.
NCT02407171 is a Phase 1 study of Lung Cancer and Melanoma that has completed, run by Yale University. The registered enrollment target is 61 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02407171, a Phase 1 study of Lung Cancer and Melanoma, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 2-part prospective trial examining the ability of Stereotactic Body Radiation Therapy (SBRT) to induce a response to MK-3475, a humanized antibody to PD-1, in patients who progress on this antibody. Patients with metastatic melanoma will be enrolled after they have progressed on anti-PD-1 therapy. Patients with metastatic NSCLC (previously untreated with anti-PD-1 or anti-PD-L1 therapy) will be enrolled and treated with MK-3475 until they exhibit progression of disease. At this point (when patients have demonstrated progression of disease) a single target lesion will be selected and treated with SBRT, and then MK-3475 will be restarted and continued until there is further progression of disease. The first phase of the study is a radiation dose escalation with a constant dose of MK-3475. The second part of the study includes expansion cohorts of NSCLC and melanoma patients.
Primary Outcome
Phase 2 primary endpoint is the overall response count of patients to post-SBRT MK-3475. Overall response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). The following are counts of those that were assessed to have the following responses: Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD), Not Evaluable.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
- DRUG MK-3475
Study Locations (1)
Connecticut
- Yale Cancer Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2019-02-19 |
| Phase | Phase 1 |
What the finished NCT02407171 record still lists
NCT02407171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 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 2 conditions, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Body Radiation Therapy (SBRT) is the first listed.
NCT02407171 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT02407171 about?
NCT02407171 is a clinical study titled "Evaluating the Combination of MK-3475 and Sterotactic Body Radiotherapy in Patients With Metastatic Melanoma or NSCLC". This is a 2-part prospective trial examining the ability of Stereotactic Body Radiation Therapy (SBRT) to induce a response to MK-3475, a humanized antibody to PD-1, in patients who progress on this antibody. Patients with metastatic melanoma will be enrolled after they have progressed on anti-PD-1 ...
What is the current status of trial NCT02407171?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2015-04-01. Estimated completion is 2019-02-19.
What conditions does trial NCT02407171 study?
This clinical trial studies the following conditions: Lung Cancer, Melanoma.
What interventions are being tested in trial NCT02407171?
The interventions under investigation include: Stereotactic Body Radiation Therapy (SBRT) (RADIATION), MK-3475 (DRUG).
Who is sponsoring clinical trial NCT02407171?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02407171 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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61 242nd of 409 higher than 167 of 409 other Lung Cancer trials
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