18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free SurivalPrimary· 1 year
The primary endpoint of this study is progression-free survival (PFS) rate at 3 months. Patients are considered progression-free at 3 months if progression is not observed at the 3-month disease assessment. PFS is defined as the time from registration to disease progression per RECIST or death, whichever occurred first.
Progressive Disease is defined as at least a 20% increase in the sum of diameters of target lesions, which must also demonstrate an absolute increase of at least 5 mm (with reference to the smallest sum on study). The appearance of one or more new lesions is also considered pr
Group
Value
95% CI
High Dose Radiation + Pembrolizumab
1
High Dose + Low Dose Radiation + Pembrolizumab
8
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
High Dose Radiation + Pembrolizumab
Serious: 3/6 (50%)
Deaths: 6/6
High Dose + Low Dose Radiation + Pembrolizumab
Serious: 7/12 (58%)
Deaths: 10/12
Serious adverse events (24 terms)
Reaction
System
High Dose Radiation + Pemb…
High Dose + Low Dose Radia…
Dysphagia
Gastrointestinal disorders
—
—
Oral/nasal bleeding
Gastrointestinal disorders
—
—
Laryngeal edema
Respiratory, thoracic and mediastinal disorders
—
—
Esophagitis
Gastrointestinal disorders
—
—
Sepsis
Infections and infestations
—
—
Lung Infection
Infections and infestations
—
—
Fall
Injury, poisoning and procedural complications
—
—
Hypotension
Vascular disorders
—
—
Aspiration
Respiratory, thoracic and mediastinal disorders
—
—
Colitis
Gastrointestinal disorders
—
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
—
Esophageal Hemorrhage
Gastrointestinal disorders
—
—
Atrial Fibrillation
Cardiac disorders
—
—
Hypomagnesemia
Metabolism and nutrition disorders
—
—
Injury, poisoning and procedural complications - Other, specify
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Head and Neck Cancer
Currently open trials in the same condition.
NCT07318220 — Prehabilitation Protocol for Head and Neck Cancer Patients
· NA
· recruiting
NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception
· recruiting
NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde
· Phase 3
· recruiting
NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca
· Phase 2
· recruiting
NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
· NA
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 25 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03085719.