Clinical Trials for Head And Neck Cancer

Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with metastatic gastrointestinal cancers (including esophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal) who are progressing on a checkpoint or CTLA-4 inhibitor, treating them with hypofractionated external beam radiation (30 Gy in 5 fractions to 1-5 lesions) in addition to ongoing immunotherapy. The aim is to determine if radiation can enhance systemic immune response and improve outcomes in this refractory population.

ClinicalTrials.gov ID: NCT04221893

A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced solid tumors eligible for standard anti–PD-1 monotherapy (e.g., melanoma, RCC, NSCLC, HCC Child-Pugh A, MSI-H tumors, urothelial, GEJ/gastric adenocarcinoma, HNSCC) are randomized to nivolumab or pembrolizumab alone versus combined with metformin (mitochondrial complex I inhibitor/AMPK activator) or rosiglitazone (PPAR-γ agonist) to reduce tumor hypoxia and improve immune function. Requires measurable disease, ECOG 0–2, and mandatory pre/post-treatment biopsies; excludes prior PD-1/PD-L1 therapy and significant cardiopulmonary/autoimmune contraindications.

ClinicalTrials.gov ID: NCT04114136

A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with esophageal or gastric adenocarcinoma and oligometastatic disease (≤3 lesions) who achieve disease control after 6–8 cycles of first-line fluoropyrimidine-based chemotherapy are randomized to continue systemic therapy versus add early local therapy with chemoradiation to primary/metastatic sites, with surgery permitted. Fluorouracil or capecitabine (antimetabolite thymidylate synthase inhibitors) are used in both arms; primary endpoint is overall survival.

ClinicalTrials.gov ID: NCT03161522

The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with RAI-avid differentiated thyroid cancer after thyroidectomy with persistent/recurrent or metastatic disease undergo 124I-PET/CT dosimetry under two TSH-stimulation methods (recombinant human TSH vs thyroid hormone withdrawal), then receive patient-specific maximum safe-dose 131I therapy based on THW dosimetry. The study evaluates per-lesion and whole-body dosimetry and correlates predicted lesional dose with subsequent treatment response.

ClinicalTrials.gov ID: NCT03841617

Phase Ib Study of Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy (SBRT) in Patients With Locoregionally Recurrent, Refractory, or Oligometastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with locoregionally recurrent, refractory, or oligometastatic (≤4 lesions) HNSCC (non-nasopharyngeal; CPS >1%) receive losartan lead-in, SBRT to involved sites, then pembrolizumab; prior RT/systemic therapy allowed but no prior PD‑1/PD‑L1 and no current ACEi/ARB. Losartan (angiotensin II type 1 receptor blocker) is used to remodel tumor stroma and enhance radiation/immunotherapy efficacy, followed by PD‑1 blockade with pembrolizumab.

ClinicalTrials.gov ID: NCT06211335

Pilot Phase II Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with recurrent/metastatic HNSCC who have progressed on or were intolerant to prior PD‑1–based therapy receive single‑agent cetuximab (weekly IV), an anti‑EGFR monoclonal antibody that blocks ligand-induced signaling and mediates ADCC. Single-arm study assessing response rate, with secondary PFS/OS and safety.

ClinicalTrials.gov ID: NCT04375384

Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head & Neck Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with head and neck cancers who have severe, opioid-refractory craniofacial or cervical neuropathic pain undergo a unilateral, incisionless MRI-guided focused ultrasound mesencephalotomy (ExAblate Neuro) targeting the contralateral mesencephalon to ablate central pain pathways. Single-arm study assessing safety and reduction in worst pain at 3 months, with patient-reported outcomes and opioid use as secondary measures.

ClinicalTrials.gov ID: NCT03894553

Alternating Treatment Plans for Participants With Advanced Thoracic/Head & Neck Cancers (ATATcH)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with untreated metastatic NSCLC (squamous or nonsquamous without targetable drivers) or incurable recurrent/metastatic HNSCC eligible for pembrolizumab-based first line receive an alternating induction schedule of chemoimmunotherapy cycles interspersed with pembrolizumab monotherapy. Regimens use standard backbones (carboplatin/paclitaxel or nab-paclitaxel for squamous NSCLC; carboplatin/pemetrexed with optional pemetrexed maintenance for nonsquamous NSCLC; carboplatin/5-FU for HNSCC) plus pembrolizumab, an anti–PD-1 antibody.

ClinicalTrials.gov ID: NCT05358548

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with locoregionally recurrent or second primary HNSCC after prior radiotherapy (≥30 Gy), confined to a single target (total GTV <7.5 cm) without metastases, are randomized to SBRT re-irradiation with or without pembrolizumab. Pembrolizumab is an anti–PD-1 monoclonal antibody added every 3 weeks for up to 2 years, with crossover permitted at progression.

ClinicalTrials.gov ID: NCT03546582

Phase II Trial of Pembrolizumab in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with unresectable locally advanced (neck-confined after prior surgery/radiation) or metastatic anaplastic/undifferentiated thyroid cancer, ECOG 0–1, and no prior PD‑1/PD‑L1 therapy receive pembrolizumab 200 mg IV q3w for up to 2 years. Pembrolizumab is a PD‑1 immune checkpoint inhibitor restoring antitumor T-cell activity; key exclusions include active CNS disease (unless treated/stable), autoimmune disease requiring systemic therapy, chronic immunosuppression, and active HIV/HBV/HCV.

ClinicalTrials.gov ID: NCT05119296