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

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.

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 recurrent or metastatic HNSCC and ECOG performance status 0–2 receive DPV-001, an autophagosome-rich vaccine intended to broaden tumor-antigen T-cell responses, followed by the PD-1 inhibitor retifanlimab. A second arm adds the GITR agonist ragifilimab but is closed to enrollment.

ClinicalTrials.gov ID: NCT04470024

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.

TrialFetch 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

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.

TrialFetch 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.

TrialFetch 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

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.

TrialFetch AI summary: Adults with measurable recurrent, metastatic, or incurable locoregionally advanced mucosal HNSCC, ECOG 0–1, and 1–2 prior systemic therapy lines including anti-PD-1/PD-L1 therapy receive PD-L1–targeting engineered NK cells (PD-L1 t-haNK), the IL-15 superagonist N-803, and the EGFR antibody cetuximab.

ClinicalTrials.gov ID: NCT06239220

A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors

Active drug

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

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.

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 advanced solid tumors that have progressed after standard therapy, including cohorts with recurrent or metastatic HNSCC, receive CHS-114 alone or with toripalimab; combination expansion requires prior progression on anti-PD-1/PD-L1 therapy. CHS-114 is an investigational anti-CCR8 antibody designed to deplete tumor-infiltrating regulatory T cells, and toripalimab is an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT05635643

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.

TrialFetch 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.

TrialFetch 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 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.

TrialFetch 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.

TrialFetch 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