drugset / Trial / NCT03085719
Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN
Phase 2
Active not recruiting
18 enrolled
Dana-Farber Cancer Institute
Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This research study is studying immunotherapy in combination with radiation therapy as a possible treatment for head \& neck cancer that has worsened or spread to another organ or part of your body. The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).
Timeline
- Start
- 2017-06-30
- Primary completion
- 2022-11-01
- Completion
- 2027-10-31
Publications
- Results So J, Droznin AD, Tiwari P, Chen YH, Chau NG, Margalit DN, Tishler RB, Hanna GJ, Mak RH, Fitzgerald KJ, Sehgal K, Li S, Gunasti L, Kim E, Minken J, Baginska J, Nau A, Diaz IG, Shim B, Janes JT 3rd, Uppaluri R, Haddad RI, Livak KJ, Schoenfeld JD. Stereotactic Body Radiation Therapy With Pembrolizumab in Programmed Cell Death Protein 1 Inhibitor-Refractory Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2026 May 1;125(1):64-77. doi: 10.1016/j.ijrobp.2025.12.043. Epub 2026 Jan 9.
- Li H, Kwon J, Kim HJ, Kim BH. Immune-modulatory effects of low-dose radiotherapy through macrophage polarization and transcriptional rewiring in triple-negative breast cancer. Biochem Biophys Res Commun. 2025 Oct 30;786:152711. doi: 10.1016/j.bbrc.2025.152711. Epub 2025 Sep 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |