Clinical Trials for Head And Neck Cancer

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

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

A Phase II Trial of Lovastatin and Pembrolizumab in Patients with RM HNSCC (LAPP)

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–positive recurrent or metastatic head and neck squamous cell carcinoma (ECOG 0–1) not candidates for salvage surgery receive pembrolizumab plus oral lovastatin; prior checkpoint inhibitor use and current statin therapy are excluded. Pembrolizumab is an anti–PD-1 antibody, and lovastatin (HMG‑CoA reductase inhibitor) is added to potentially enhance antitumor immunity via mevalonate pathway inhibition.

ClinicalTrials.gov ID: NCT06636734

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

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 nasopharyngeal carcinoma after platinum–gemcitabine and prior PD‑1/L1 therapy (up to two prior lines; ECOG 0–2; treated/stable brain mets allowed) are randomized to nivolumab (PD‑1) plus ipilimumab (CTLA‑4) with or without cabozantinib, a multikinase inhibitor of MET/VEGFR2/AXL. Aims to determine whether adding cabozantinib improves outcomes versus dual checkpoint blockade alone.

ClinicalTrials.gov ID: NCT05904080

Phase III Randomized Trial of Immunotherapy With or Without Consolidative Radiotherapy for Oligometastatic 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 oligometastatic HNSCC (≤4 metastatic sites) who have not progressed after 3 cycles of pembrolizumab plus platinum/fluorouracil- or paclitaxel-based chemotherapy are randomized to maintenance pembrolizumab (PD-1 inhibitor) with consolidative radiotherapy to all disease sites versus pembrolizumab alone. Requires measurable disease, ECOG 0–1 at induction (0–2 at randomization), no prior head/neck RT, and no active autoimmune disease needing systemic therapy.

ClinicalTrials.gov ID: NCT05721755

Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

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 or metastatic nasopharyngeal carcinoma, systemic treatment–naïve for the metastatic setting and with measurable disease, receive induction gemcitabine/platinum plus toripalimab (anti–PD-1), with optional switch to carboplatin from cycle 2, followed by maintenance toripalimab. Excludes candidates for curative local therapy, prior systemic therapy for R/M disease, early recurrence after chemoradiation (<6 months), rapidly progressive disease, and active/untreated CNS metastases.

ClinicalTrials.gov ID: NCT06457503