Clinical Trials for Head And Neck Cancer

Phase I Trial of CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer

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.

HealthScout AI summary: First-line treatment for adults with unresectable/metastatic gastric, GEJ, or esophageal adenocarcinoma or squamous cell carcinoma (ECOG 0–1), testing oral IRAK4 inhibitor emavusertib (CA‑4948; targets TLR/IL‑1R→NF‑κB signaling, with FLT3/CLK activity) added to mFOLFOX7 plus PD‑1 blockade. HER2‑negative patients receive emavusertib + mFOLFOX7 + nivolumab; HER2‑positive patients receive emavusertib + mFOLFOX7 + pembrolizumab + trastuzumab.

ClinicalTrials.gov ID: NCT05187182

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

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.

HealthScout AI summary: Adults with metastatic or unresectable esophageal squamous cell carcinoma who progressed after one prior platinum regimen that included PD‑1/PD‑L1 therapy; compares standard second-line paclitaxel or irinotecan versus investigational sacituzumab tirumotecan (TROP2-directed topoisomerase I ADC), with previously planned pembrolizumab/MK‑4830 combinations closed to enrollment. Primary focus is safety and objective response with blinded central review, with secondary endpoints including PFS and OS.

ClinicalTrials.gov ID: NCT05319730

Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer

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.

HealthScout AI summary: Adults with unresectable, recurrent, or metastatic head and neck squamous cell carcinoma needing palliative RT and with an injectable lesion receive intratumoral RiMO-301 (hafnium-based radioenhancer) plus a PD-1 inhibitor (pembrolizumab or nivolumab) followed by hypofractionated radiotherapy. Suitable for ECOG 0–2 patients eligible for PD-1 therapy; excludes symptomatic CNS disease and active autoimmune conditions requiring recent systemic therapy.

ClinicalTrials.gov ID: NCT05838729

Phase Ib/II Study of NT219 in Combination With Pembrolizumab or Cetuximab in Patients With 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.

HealthScout AI summary: Adults with recurrent/metastatic mucosal HNSCC (non‑NPC), ECOG 0–2, receive NT219 (a first‑in‑class dual IRS1/2 degrader and STAT3 inhibitor aimed at overcoming resistance via PI3K/AKT/STAT3 pathways) combined with either pembrolizumab (for PD‑1–eligible or previously PD‑1–benefiting patients; paired biopsies required) or cetuximab (for PD‑1–refractory or cetuximab‑eligible patients). Excludes active uncontrolled CNS disease and significant autoimmune/immunosuppression per cohort, with treatment until progression or intolerance.

ClinicalTrials.gov ID: NCT06919666

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

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 advanced/metastatic solid tumors (dose escalation) and recurrent/metastatic head and neck squamous cell carcinoma after platinum and/or PD‑1/PD‑L1 therapy receive CHS‑114, an afucosylated anti‑CCR8 IgG1 designed to deplete intratumoral Tregs, as monotherapy or combined with the PD‑1 inhibitor toripalimab. Key inclusion: measurable disease, ECOG 0–1; HNSCC cohorts exclude nasopharyngeal primary and require tumor tissue; excludes prior anti‑CCR8 therapy and excessive prior lines per cohort.

ClinicalTrials.gov ID: NCT05635643

A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN)

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.

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.

No known activity

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

HealthScout AI summary: Adults with PD-L1–high (CPS ≥20) recurrent or metastatic HNSCC (non-nasopharyngeal) and ECOG 0–1 are randomized to pembrolizumab alone versus pembrolizumab plus INBRX-106, a hexavalent OX40 (CD134) agonist antibody that enhances T‑cell costimulation. Prior systemic therapy for R/M disease is not allowed; key exclusions include active CNS metastases and significant autoimmune disease.

ClinicalTrials.gov ID: NCT06295731

Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: Adults with recurrent/metastatic oral cavity cancer after or ineligible for standard first-line immunotherapy/chemo-immunotherapy (ECOG 0–2) receive a fully oral metronomic regimen of methotrexate (antifolate), erlotinib (EGFR TKI), and celecoxib (COX‑2 inhibitor) in 28‑day cycles, delivered with decentralized/virtual components. Excludes significant cardiac risk, active serious infection/bleeding, uncontrolled viral hepatitis/HIV, pregnancy, and concurrent investigational therapy.

ClinicalTrials.gov ID: NCT06997068

A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: Adults with previously irradiated stage II–IV laryngeal or hypopharyngeal squamous cell carcinoma undergoing salvage total laryngectomy receive intraoperative indocyanine green (ICG) fluorescence angiography with the SPY system to assess mucosal perfusion, with resection of hypoperfused tissue prior to reconstruction. ICG is a near-infrared fluorescent dye used for real-time perfusion imaging, aiming to reduce postoperative pharyngocutaneous fistula, particularly in intraoperatively defined high-risk cases.

ClinicalTrials.gov ID: NCT06831149

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

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: This trial enrolls adult patients with advanced solid tumors, including NSCLC, who have progressed after anti-PD-1/PD-L1 therapy to evaluate MEM-288, an oncolytic adenovirus with immunostimulatory properties, alone and in combination with the PD-1 inhibitor nivolumab.

ClinicalTrials.gov ID: NCT05076760

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

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: This trial involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453