Clinical Trials for Head And Neck Cancer

A Phase 2 Study of Darolutamide in Combination With Leuprolide Acetate in Hormone-Therapy Naive Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland 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.

HealthScout AI summary: Single-arm study for adults with measurable, AR-positive recurrent/unresectable or metastatic salivary gland cancer (ECOG 0–2), including those with treated/stable brain mets; excludes prior AR-targeted therapy except adjuvant/neoadjuvant with relapse >6 months. Patients receive darolutamide (nonsteroidal AR antagonist inhibiting AR nuclear translocation/DNA binding) orally BID plus leuprolide acetate (GnRH agonist ADT) IM every 4 or 12 weeks.

ClinicalTrials.gov ID: NCT05669664

A Phase 2 Trial of PD-L1 t-haNK, N-803 IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with recurrent/metastatic or unresectable HNSCC after 1–2 prior systemic lines including anti–PD-1/L1 receive a triple regimen of PD-L1 t-haNK (allogeneic NK-92–derived CAR-NK targeting PD-L1 with high-affinity CD16 and IL-2 support), N-803 (IL-15 superagonist activating NK/CD8 T cells), and cetuximab. Excludes ≥3 prior R/M lines, active CNS mets, significant immunosuppressed autoimmunity, or active HBV/HCV; imaging every 8 weeks assesses response.

ClinicalTrials.gov ID: NCT06239220

Phase II Trial of Pulsed Dose Chemotherapy Plus Pembrolizumab in the First Line Treatment of Recurrent/Metastatic HNSCC

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 PD-L1 CPS >1 recurrent/metastatic HNSCC (ECOG 0–2) receive pembrolizumab (anti–PD-1) starting cycle 1 with pulsed carboplatin/paclitaxel added every third pembrolizumab cycle (q9 weeks) for four cycles, then pembrolizumab maintenance. Excludes prior systemic therapy for R/M disease, recent PD-1/PD-L1 in R/M setting, active autoimmune disease requiring treatment, ILD/pneumonitis, or significant neuropathy.

ClinicalTrials.gov ID: NCT06052839

A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases

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 locoregional recurrent, non-nasopharyngeal HNSCC (M0), CPS ≥1, PD-1/PD-L1–naïve, with at least one lesion accessible for light activation are randomized to pembrolizumab plus ASP-1929 photoimmunotherapy (cetuximab–IRDye700DX conjugate targeting EGFR, activated by 690 nm light) versus pembrolizumab-based standard of care (mono or with chemo). The study tests whether adding EGFR-targeted photoimmunotherapy to PD-1 blockade improves overall survival; key exclusions include CNS metastases, significant autoimmune disease, and conditions contraindicating photosensitive procedures.

ClinicalTrials.gov ID: NCT06699212

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory 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 salivary gland cancers enroll into two cohorts: adenoid cystic carcinoma with recent progression, or non-ACC (SDC, intermediate/high-grade adenocarcinoma NOS, MEC) after ≤3 prior palliative chemotherapies (HER2+ must have received HER2 therapy), ECOG 0–1. Treatment is sacituzumab govitecan, a Trop-2–targeted antibody–drug conjugate delivering SN-38, given IV on days 1 and 8 of 21-day cycles; safety and efficacy are assessed separately by histology.

ClinicalTrials.gov ID: NCT05884320

An Open-Label Phase II Clinical Trial Assessing the Safety, Feasibility, Efficacy and Immunological Correlates of Heterologous Prime-Boost With pBI-11 (IM) and TA-HPV (IM) Combined With Pembrolizumab as Treatment for Patients With Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal 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.

HealthScout AI summary: Adults with recurrent/metastatic, p16+/hrHPV+ oropharyngeal carcinoma and PD-L1 CPS≥1 eligible for first-line pembrolizumab receive a heterologous HPV vaccine prime-boost (pBI-11 DNA vaccine encoding HPV16/18 antigens and TA-HPV recombinant vaccinia expressing HPV16/18 E6/E7) plus pembrolizumab. Aims to enhance HPV-specific cellular immunity and improve response versus PD-1 blockade alone; excludes prior systemic therapy for R/M disease and patients with active CNS metastases or significant immunosuppression/autoimmunity.

ClinicalTrials.gov ID: NCT05799144

Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

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 HNSCC (oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal, or unknown primary) after ≥2 prior systemic lines and amenable to salvage surgery receive an autologous tumor membrane vesicle (TMV) vaccine derived from their resected tumor, alone or combined with pembrolizumab. TMV is a personalized intradermal vaccine presenting native tumor membrane antigens/neoantigens to prime T-cell responses; the combination adds anti–PD-1 checkpoint blockade.

ClinicalTrials.gov ID: NCT06868433

A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ 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.

HealthScout AI summary: Adults with unresectable recurrent/metastatic HPV16-positive, PD-L1 CPS ≥1 HNSCC (non-nasopharyngeal) and no prior systemic therapy in the R/M setting are randomized to pembrolizumab with or without PDS0101. PDS0101 is an investigational Versamune-based HPV16 antigen vaccine aiming to induce HPV16-specific CD8/CD4 T cells to enhance response to PD-1 blockade.

ClinicalTrials.gov ID: NCT06790966

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

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 platinum-refractory recurrent/metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx), PD-L1 CPS ≥1, ECOG 0–2, and no prior systemic therapy for R/M disease are randomized to pembrolizumab alone vs pembrolizumab plus cetuximab. Pembrolizumab is an anti–PD-1 antibody; cetuximab is an anti-EGFR antibody, with the combination tested to enhance efficacy in this setting.

ClinicalTrials.gov ID: NCT06589804

Restoration of Radioiodine Uptake with Selpercatinib in RET Fusion-Positive Radioiodine-Refractory Thyroid Cancer: a Phase 2 Study Performed in Collaboration with the International Thyroid Oncology Group (ITOG)

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: RET fusion–positive, radioiodine-refractory differentiated thyroid cancer (adolescents ≥12 and adults) with metastatic/unresectable disease, limited prior therapy, and no prior RET TKI receive a short selpercatinib lead-in (selective RET kinase inhibitor) to restore radioiodine uptake followed by therapeutic I-131 under rhTSH, with an option for a second selpercatinib/I-131 course if uptake is restored. Key allowances include treated/stable brain metastases; exclusions include QT-prolonging risks and recent I-131.

ClinicalTrials.gov ID: NCT05668962