Pembrolizumab in Combination With CRT for LA-SCCHN

ClinicalTrials.gov ID: NCT02586207

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Official title

Phase Ib Study of Pembrolizumab in Combination With Chemo Radiotherapy (CRT) for Locally-advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02586207
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Sanford Health; Other
Enrollment: 59 participants

Conditions and interventions

Conditions

Interventions

Drug · Radiation

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2015 (Type not available)
Primary completion: Sep 29, 2020 (Actual)
Completion: Aug 2025 (Actual)
Last update posted: Oct 7, 2025

2015 – 2025

United States locations

U.S. sites: 4
U.S. states: 3
U.S. cities: 4

Facility	City	State	ZIP	Site status
UCSD Moores Cancer Center	La Jolla	California	92093-0698	—
Sanford-Bismarck Medical Center	Bismarck	North Dakota	58501	—
Sanford-Roger Maris Cancer Center	Fargo	North Dakota	58122	—
Sanford Health Cancer Center	Sioux Falls	South Dakota	57104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02586207, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 7, 2025 · Synced Nov 15, 2026