Clinical Trials for Head And Neck Cancer

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.

TrialFetch 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.

TrialFetch 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 Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study

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.

TrialFetch AI summary: Adults with previously irradiated head and neck squamous cell carcinoma requiring salvage neck dissection for persistent or recurrent nonmucosal nodal disease undergo placement of a buried free adipofascial anterolateral thigh fat flap to augment soft-tissue coverage. The study evaluates surgical safety/complications and explores impacts on neck morbidity, function, and quality of life over 12 months.

ClinicalTrials.gov ID: NCT05889091

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.

TrialFetch 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.

TrialFetch 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

Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

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.

TrialFetch AI summary: Adults with unresectable/metastatic non-uveal melanoma or recurrent/metastatic HNSCC that progressed on or within 12 weeks of prior anti–PD-1 therapy receive nivolumab plus daily cabozantinib, with enrollment stratified by tumor mutational burden and Tumor Inflammation Score. Cabozantinib is a multikinase inhibitor (MET/VEGFR2/AXL) intended to disrupt angiogenesis and the immunosuppressive microenvironment to synergize with PD-1 blockade.

ClinicalTrials.gov ID: NCT05136196

A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers

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.

TrialFetch AI summary: Adults with recurrent, metastatic, or unresectable HER2-expressing salivary gland cancers: HER2-positive (IHC 3+ or amplified) randomized to docetaxel + trastuzumab vs trastuzumab emtansine (T-DM1, HER2-directed microtubule-inhibitor ADC) with crossover at progression; HER2-low (IHC 1+ or 2+ without amplification) receive trastuzumab deruxtecan (T-DXd, HER2-directed topoisomerase I inhibitor ADC). Eligible with ECOG 0–2, measurable disease required for HER2-low; treated/stable and select untreated stable brain metastases allowed.

ClinicalTrials.gov ID: NCT05408845

Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer

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.

TrialFetch AI summary: Adults with head and neck squamous cell carcinoma eligible for intratumoral injection: either unresectable/recurrent/metastatic disease post–PD-1/PD-L1 and standard therapies (IT VLPONC-01 alone) or resectable stage I–IVb disease planned for surgery (neoadjuvant pembrolizumab with or without IT VLPONC-01). VLPONC-01 is a virus replicon particle–delivered self-amplifying RNA encoding IL-12 to drive local innate/adaptive immune activation and potentially sensitize tumors to PD-1 blockade.

ClinicalTrials.gov ID: NCT06736379

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.

TrialFetch 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

3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial

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.

TrialFetch AI summary: Adults with incurable head and neck squamous cell carcinoma (including prior RT/systemic therapy and allowing metastatic disease) are randomized to short-course SBRT in 3–5 fractions versus conventional palliative external-beam radiation. The trial compares symptom relief and local control while monitoring toxicity.

ClinicalTrials.gov ID: NCT05674396