Trials / Completed

CompletedNCT02586207

Pembrolizumab in Combination With CRT for LA-SCCHN

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

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 59 (actual)

Sponsor: Sanford Health · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final protocol-specified contact. After a screening phase of 28 days, eligible subjects will receive treatment on Day -7 with a loading dose of the study drug. This will continue during concurrent therapy with cisplatin and radiation, which will begin on day 1. Treatment will continue until completion of therapy, documented confirmed disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the patient, noncompliance with trial treatment or procedure requirements; or administrative reasons. After the end of treatment, each patient will be followed for 30 days for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the patient initiates new anticancer therapy, whichever is earlier). Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until end of study disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival until death, withdrawal of consent, or the Investigator is notified by Sanford Research to discontinue follow-up

Conditions

Interventions

Type	Name	Description
DRUG	pembrolizumab (MK-3475)	200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
DRUG	Cisplatin	Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
RADIATION	Radiation	70 Gy fractionated over 35 days

Timeline

Start date: 2015-11-01
Primary completion: 2020-09-29
Completion: 2025-08-01
First posted: 2015-10-26
Last updated: 2025-10-07
Results posted: 2021-01-15

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02586207. Inclusion in this directory is not an endorsement.