Clinical Trials for Head And Neck Cancer

Phase II Trial of Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111

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.

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 unresectable, recurrent, or metastatic androgen receptor–positive salivary gland carcinoma (ECOG 0–1), including previously treated patients without prior ADT or checkpoint inhibitors, receive goserelin (GnRH agonist ADT) plus pembrolizumab (anti–PD-1) until progression or toxicity. Stable, treated brain metastases are allowed; key exclusions include active autoimmune disease requiring systemic therapy and significant immunosuppression.

ClinicalTrials.gov ID: NCT03942653

A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

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 HNSCC (oropharynx, oral cavity, hypopharynx, or larynx) receive subcutaneous amivantamab—an EGFR/MET bispecific antibody—either as monotherapy or combined with pembrolizumab, paclitaxel, or pembrolizumab plus carboplatin, with cohort-specific HPV/p16 requirements and prior therapy allowances. The study assesses safety and antitumor activity across these regimens and establishes the recommended dose for the amivantamab-paclitaxel combination.

ClinicalTrials.gov ID: NCT06385080

Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)

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 previously treated recurrent/metastatic HNSCC (oral cavity, oropharynx, hypopharynx, larynx; KPS >60%) receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous iC9.CAR-CSPG4 T cells, an anti-CSPG4 CAR T product with an inducible caspase-9 safety switch for potential rapid ablation. Key exclusions include significant cardiovascular disease, recent stroke/TIA, and severe hypersensitivity to cyclophosphamide or fludarabine.

ClinicalTrials.gov ID: NCT06096038

An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid 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.

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 metastatic, RAI‑refractory differentiated thyroid cancer with RECIST-defined progression (ECOG 0–2) receive oral cyclophosphamide (intermittent low-dose) plus sirolimus daily. Sirolimus targets mTORC1 (PI3K/AKT/mTOR pathway inhibition), aiming for antiproliferative/antiangiogenic synergy with metronomic cyclophosphamide; excludes prior mTOR inhibitor exposure and requires available prior NGS.

ClinicalTrials.gov ID: NCT03099356

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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.

HealthScout AI summary: This trial involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

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: This trial involves patients with advanced or metastatic solid tumors expressing Nectin-4, including urothelial carcinoma, triple-negative breast cancer, non-small cell lung cancer, and ovarian cancer, who have exhausted standard therapy options. It evaluates LY4052031, an antibody-drug conjugate that targets Nectin-4 to deliver a topoisomerase I inhibitor, aiming to assess its safety, tolerability, and efficacy in these patients.

ClinicalTrials.gov ID: NCT06465069

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors

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: The trial is for adult patients with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma who have no remaining standard treatment options, and it evaluates the safety, tolerability, and dosing of the investigational drug LB-LR1109, administered intravenously.

ClinicalTrials.gov ID: NCT06332755

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors

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: The trial evaluates the investigational antibody-drug conjugate XB010, which targets the 5T4 antigen to inhibit tumor growth, in adults with locally advanced or metastatic solid tumors who lack alternative treatment options; it assesses XB010 as both a monotherapy and in combination with pembrolizumab across various tumor types including non-small cell lung cancer, hormone-receptor-positive and triple-negative breast cancer, head and neck, and esophageal squamous cell cancers.

ClinicalTrials.gov ID: NCT06545331

A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Clinical Activity of DECOY20 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced Solid Tumors

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: This trial involves adult patients with advanced solid tumors, including specific types like hepatocellular carcinoma and non-small cell lung cancer, who have exhausted standard treatments, and assesses the safety and clinical activity of Decoy20, a Toll-like receptor agonist immunotherapy, both alone and in combination with the PD-1 inhibitor tislelizumab.

ClinicalTrials.gov ID: NCT05651022

Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors

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: This trial enrolls patients aged 18 and older with advanced solid tumors, including RCC, CRPC, NSCLC, SCCHN, CRC, endometrial, and ovarian cancers, who have failed or are ineligible for standard treatments, to evaluate TT-10, an adenosine A2A receptor antagonist, and TT-4, an adenosine A2B receptor antagonist, administered as single agents and in combination.

ClinicalTrials.gov ID: NCT04969315