Clinical Trials for Head And Neck Cancer

The 5-Fluorouracil Response and Optimization STudy (The FROST Trial): A Randomized Phase II Trial of Two Dosage Regimens (2D-Q2W vs 4D-Q3W) of 5-Fluorouracil (5-FU) in Patients With Platinum and PD-1 Inhibitor Pre-treated Recurrent or Metastatic 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.

TrialFetch AI summary: Randomized study for adults with measurable recurrent/metastatic HNSCC after prior platinum and PD-1 inhibitor therapy, ECOG 0–2, and no prior 5-FU in the recurrent/metastatic setting. Patients receive single-agent 5-FU, a cytotoxic fluoropyrimidine that inhibits thymidylate synthase and disrupts RNA/DNA synthesis, using either a 46-hour infusion every 2 weeks or a 4-day continuous infusion every 3 weeks.

ClinicalTrials.gov ID: NCT07419464

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

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: This trial enrolls adults with advanced or metastatic solid tumors harboring KRAS G12C mutations (including pretreated NSCLC and other solid tumors), who receive a combination of the investigational KRAS G12C inhibitors RMC-6291 and RMC-6236. Both agents specifically inhibit KRAS G12C mutant protein to suppress tumor growth, and eligibility includes both KRAS G12C inhibitor–naïve and previously treated patients, excluding those with primary CNS tumors or active brain metastases.

ClinicalTrials.gov ID: NCT06128551

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers

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: This trial enrolls adults with advanced or metastatic NSCLC, melanoma, endometrial cancer, or HNSCC who have progressed after standard therapies including prior anti-PD-1/L1 agents, and evaluates the combination of STC-15 (an oral METTL3 inhibitor targeting RNA methylation) plus toripalimab (anti-PD-1 antibody). Eligible patients must have measurable disease, ECOG 0–1, and no active CNS disease.

ClinicalTrials.gov ID: NCT06975293

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

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.

TrialFetch AI summary: This trial enrolls adults with recurrent or second primary tumors in body sites previously treated with radiotherapy—including CNS, head and neck, breast, thoracic, GI, GU, and gynecological cancers—to evaluate reirradiation using pencil beam scanning proton therapy, which aims to provide effective tumor control with reduced toxicity compared to standard photon techniques. No investigational drugs are included, and some cohorts may not allow concurrent chemotherapy.

ClinicalTrials.gov ID: NCT05313191

Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)

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.

TrialFetch AI summary: This trial enrolls adults with metastatic gastrointestinal cancers (including esophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal) who are progressing on a checkpoint or CTLA-4 inhibitor, treating them with hypofractionated external beam radiation (30 Gy in 5 fractions to 1-5 lesions) in addition to ongoing immunotherapy. The aim is to determine if radiation can enhance systemic immune response and improve outcomes in this refractory population.

ClinicalTrials.gov ID: NCT04221893

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen

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.

TrialFetch AI summary: Adults with metastatic or locally advanced/inoperable GI cancers (colorectal and non-colorectal; ECOG 0–1; excluding dMMR/MSI-H, known DPD deficiency, and prior oxaliplatin/fluoropyrimidine) receive an oxaliplatin/leucovorin backbone with infusional 5-FU, using an adaptive algorithm to escalate 5-FU from 2,400 to up to 3,200 mg/m2 over early cycles based on tolerance. Investigational aspect is individualized 5-FU dose escalation within a FOLFOX-like regimen to optimize dose intensity and assess response, PFS, and PK correlations.

ClinicalTrials.gov ID: NCT05780684

A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies

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.

TrialFetch AI summary: Adults with advanced solid tumors eligible for standard anti–PD-1 monotherapy (e.g., melanoma, RCC, NSCLC, HCC Child-Pugh A, MSI-H tumors, urothelial, GEJ/gastric adenocarcinoma, HNSCC) are randomized to nivolumab or pembrolizumab alone versus combined with metformin (mitochondrial complex I inhibitor/AMPK activator) or rosiglitazone (PPAR-γ agonist) to reduce tumor hypoxia and improve immune function. Requires measurable disease, ECOG 0–2, and mandatory pre/post-treatment biopsies; excludes prior PD-1/PD-L1 therapy and significant cardiopulmonary/autoimmune contraindications.

ClinicalTrials.gov ID: NCT04114136

A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases

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.

TrialFetch AI summary: Adults with esophageal or gastric adenocarcinoma and oligometastatic disease (≤3 lesions) who achieve disease control after 6–8 cycles of first-line fluoropyrimidine-based chemotherapy are randomized to continue systemic therapy versus add early local therapy with chemoradiation to primary/metastatic sites, with surgery permitted. Fluorouracil or capecitabine (antimetabolite thymidylate synthase inhibitors) are used in both arms; primary endpoint is overall survival.

ClinicalTrials.gov ID: NCT03161522

The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study

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.

TrialFetch AI summary: Adults with previously irradiated head and neck squamous cell carcinoma requiring salvage neck dissection for persistent or recurrent nonmucosal nodal disease undergo placement of a buried free adipofascial anterolateral thigh fat flap to augment soft-tissue coverage. The study evaluates surgical safety/complications and explores impacts on neck morbidity, function, and quality of life over 12 months.

ClinicalTrials.gov ID: NCT05889091

The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in 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.

TrialFetch AI summary: Adults with RAI-avid differentiated thyroid cancer after thyroidectomy with persistent/recurrent or metastatic disease undergo 124I-PET/CT dosimetry under two TSH-stimulation methods (recombinant human TSH vs thyroid hormone withdrawal), then receive patient-specific maximum safe-dose 131I therapy based on THW dosimetry. The study evaluates per-lesion and whole-body dosimetry and correlates predicted lesional dose with subsequent treatment response.

ClinicalTrials.gov ID: NCT03841617