Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02586207 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab in Combination With CRT for LA-SCCHN
A Phase 1 study of Head and Neck Cancer and Squamous Cell Carcinoma, sponsored by Sanford Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 4
- Study locations
NCT02586207 is a Phase 1 study of Head and Neck Cancer and Squamous Cell Carcinoma that has completed, run by Sanford Health. The registered enrollment target is 59 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT02586207, a Phase 1 study of Head and Neck Cancer and Squamous Cell Carcinoma, has completed, sponsored by Sanford Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 4
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (77% lower). The listed sponsor is Sanford Health, which has 34 total studies on file at ClinicalTrials.gov.
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.
NCT02586207 reports 4 study locations spanning 3 distinct geographic areas - top geographies include North Dakota, California, South Dakota.
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.
What interventions are being tested in trial NCT02586207?
The interventions under investigation include: Cisplatin (DRUG), Radiation (RADIATION), pembrolizumab (MK-3475) (DRUG).
Who is sponsoring clinical trial NCT02586207?
This trial is sponsored by Sanford Health, which has 34 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
RECRUITING · Phase 1
-
RAPA-201 Therapy of Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
RECRUITING · Phase 1
-
TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers
RECRUITING · Phase 1
-
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.