Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive Stereotactic Body Radiation Therapy (SBRT) over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years.

Patients receive Stereotactic Body Radiation Therapy (SBRT) over 2 weeks. Arm II patients who experience progressive disease within 2 years after the start of SBRT will be allowed to cross over to receive pembrolizumab for up to 2 years.

Stereotactic Body Radiation Therapy (SBRT)

Stuart J. Wong, MD

Margaret Ramirez

Jared Robbins, MD

Danielle Ames

Jimmy Caudell, MD

Holly Sasak

Shlomo Koyfman, MD

Teresa Roberts, RN, BSN

Neal Dunlap, MD

Annie Jose

Michael Dyer, MD

Wade Thorstad, MD

Christopher Kim

Bhupesh Parashar, MD

Ilaina Monroe, BS

Muhammad Riaz, MD

Tiffany Elsea

Dukagjin Blakaj, MD

Irina Geier, RN

Mitch Machtay, MD

Holly Kilpatrick, RN

Thomas Galloway, MD

Karen Holeva

David Clump, MD, PhD

Kay Lieb, RN

Matthew Lasowski

Stuart Wong, MD

Holly Toker

Brock Debenham, MD

Mom Phat, RN

Phuc Felix Nguyen-Tan, MD

Marianna Perna, CCRP, CCRC

George Shenouda, MD

This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).

Safety Run-In:

To evaluate the safety of the addition of pembrolizumab (anti PD-1 immunotherapy) to re-irradiation with SBRT for patients with recurrent or new second primary head and neck squamous cell carcinoma (HNSCC).

Phase II:

To compare progression-free survival (PFS) for patients with recurrent or new second primary head and neck squamous cell carcinoma with SBRT re-irradiation with or without pembrolizumab.

OUTLINE:

Safety Run-In: Patients receive SBRT over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years.

Phase II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive SBRT over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years.

ARM II: Patients receive SBRT over 2 weeks. Arm II patients who experience progressive disease within 2 years after the start of SBRT will be allowed to cross over to receive pembrolizumab for up to 2 years.

After the completion of study treatment, patients are followed up every 6 months for 3 years.

SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

KEYSTROKE: A Randomized Phase II Study of Pembrolizumab (KEYTRUDA®) Plus Stereotactic Re-irradiation Versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma

The time from randomization to the first documented progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever comes first.

The time from randomization to death due to any cause.

Merck Sharp & Dohme LLC

RTOG Foundation, Inc.

Spots Global Cancer Trial Database for keystroke

Every month we try and update this database with for keystroke cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for keystroke

Every month we try and update this database with for keystroke cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for keystroke cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.