Clinical Trials for Head And Neck Cancer

A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 or metastatic HNSCC (ECOG 0–2; controlled CNS mets allowed) receive an investigational multivalent autophagosome vaccine (DPV-001; off‑the‑shelf allogeneic microvesicle vaccine delivering broad tumor antigens to prime dendritic cells/T‑cell responses) followed by sequenced PD‑1 blockade (retifanlimab); a closed arm also tested addition of a GITR agonist (INCAGN01876) to enhance effector T cells and reduce Treg suppression. Excludes active autoimmune disease requiring significant immunosuppression; mandatory biopsies are required.

ClinicalTrials.gov ID: NCT04470024

A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)

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.

HealthScout AI summary: Adults with untreated recurrent/metastatic HNSCC (ECOG 0–1, measurable disease, tissue for PD-L1) receive pembrolizumab (anti–PD‑1) alone or with ctDNA-guided, response-adaptive pulsed carboplatin/paclitaxel, with subsequent therapy intensity adjusted based on ctDNA dynamics. Excludes prior PD‑1 therapy, active autoimmune disease requiring immunosuppression, brain mets, and baseline non-measurable ctDNA.

ClinicalTrials.gov ID: NCT05420948

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.

HealthScout 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

A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy

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.

HealthScout AI summary: Single-arm study for adults with recurrent/metastatic HNSCC (oral cavity, oropharynx, hypopharynx, larynx, sinonasal) who progressed after first-line anti–PD-(L)1–based therapy (up to two prior R/M lines), ECOG 0–1. Patients receive sacituzumab govitecan (Trop-2–targeted ADC delivering SN-38/topoisomerase I inhibitor) plus cetuximab (EGFR mAb), with RECIST v1.1 response as primary endpoint.

ClinicalTrials.gov ID: NCT07063212

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.

HealthScout 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.

HealthScout 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

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.

HealthScout 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

An Open Label, Phase I Dose-finding and Expansion Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers, and BI 765179 in Combination With Pembrolizumab in First-line PD-L1-positive Metastatic or Incurable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 expected to be FAP-high, refractory or unsuitable for standard therapy (ECOG 0–1), receive BI 765179, a FAP×CD137 (4‑1BB) bispecific agonist designed to activate 4‑1BB in FAP-rich stroma, as monotherapy or with the PD‑1 inhibitor ezabenlimab. A separate cohort enrolls first‑line PD‑L1–positive metastatic or incurable, recurrent HNSCC (non‑nasopharyngeal) to receive BI 765179 plus pembrolizumab.

ClinicalTrials.gov ID: NCT04958239

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

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.

HealthScout AI summary: Adults with recurrent, resectable oral cavity squamous cell carcinoma (ECOG 0–1) ≥3 months after prior curative therapy receive 6 weeks of neoadjuvant cemiplimab (PD‑1 inhibitor) plus cetuximab (anti‑EGFR), followed by salvage surgery and optional adjuvant cemiplimab up to 1 year. Excludes distant metastases and prior PD‑1/PD‑L1 therapy.

ClinicalTrials.gov ID: NCT06448026

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

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.

HealthScout AI summary: Adults with EBV-associated recurrent/metastatic nasopharyngeal carcinoma who have not progressed after first-line platinum–gemcitabine plus nivolumab induction are randomized to maintenance nivolumab versus nivolumab plus relatlimab. Relatlimab is an anti–LAG-3 immune checkpoint inhibitor combined with PD-1 blockade to enhance antitumor immunity; baseline and post-induction plasma EBV DNA monitoring is required.

ClinicalTrials.gov ID: NCT06029270