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Pembrolizumab in Combination With CRT for LA-SCCHN
NCT02586207 · View on ClinicalTrials.gov ↗
Study Summary
This is a single-arm, multi-site, open-label trial of pembrolizumab (MK-3475) used in combination with standard, cisplatin-based, definitive chemoradiotherapy (CRT) in patients with stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Approximately 39 patients with Stage III-IVB SCCHN will be enrolled to evaluate both the safety and efficacy of this novel combination. Subjects will not be randomized and will all receive the study treatment. Treatment will consist of a loading dose of pembrolizumab 200 mg IV given 7 days prior to initiation of CRT (day-7). CRT with cisplatin 40 mg/m2 IV weekly and head and neck radiation at 70 Gy fractionated at 2 Gy once daily over 35 days, will begin on day 1. CRT will end on approximately day 46-50. Pembrolizumab 200 mg IV will continue following CRT in an adjuvant fashion starting on day 57 for an additional 5 doses, as tolerated, through day 141. Subjects will be evaluated for response following treatment.
Conditions Studied
Interventions
- DRUG Cisplatin
- RADIATION Radiation
- DRUG pembrolizumab (MK-3475)
Study Locations (4)
North Dakota
- Sanford-Bismarck Medical Center — Bismarck
- Sanford-Roger Maris Cancer Center — Fargo
California
- UCSD Moores Cancer Center — La Jolla
South Dakota
- Sanford Health Cancer Center — Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2015-11 |
| Est. Completion | 2025-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02586207
The ClinicalTrials.gov registry entry for NCT02586207 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanford Health, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions — of which Cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02586207 reports 4 study locations spanning 3 distinct geographic areas — top geographies include North Dakota, California, South Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02586207 about?
NCT02586207 is a clinical study titled "Pembrolizumab in Combination With CRT for LA-SCCHN". This is a single-arm, multi-site, open-label trial of pembrolizumab (MK-3475) used in combination with standard, cisplatin-based, definitive chemoradiotherapy (CRT) in patients with stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Approximately 39 patients with Stage III-IVB SCCHN...
What is the current status of trial NCT02586207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2015-11. Estimated completion is 2025-08.
What conditions does trial NCT02586207 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Squamous Cell Carcinoma, Oropharynx Cancer, Oral Cavity Cancer, Larynx Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02586207?
The interventions under investigation include: Cisplatin (DRUG), Radiation (RADIATION), pembrolizumab (MK-3475) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02586207?
This trial is sponsored by Sanford Health, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02586207 being conducted?
This trial has 4 study locations across California, North Dakota, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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