Clinical Trials for Head And Neck Cancer

A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas

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.

Active drug

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

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 unresectable locally advanced or metastatic HER2-negative esophageal, gastroesophageal junction, or gastric adenocarcinoma who have not received treatment for advanced disease receive first-line ivonescimab plus FOLFOX. Ivonescimab is a bispecific antibody targeting PD-1 and VEGF-A; it is given alone for the first treatment, with FOLFOX added from cycle 2 onward.

ClinicalTrials.gov ID: NCT07070466

Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression

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.

Active drug

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

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–positive (CPS ≥1), incurable recurrent or metastatic HNSCC who have not received systemic therapy for recurrent or metastatic disease are randomized within HPV-positive and HPV-negative cohorts. Treatment is investigational fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) versus cemiplimab plus placebo.

ClinicalTrials.gov ID: NCT06769698

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

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.

Active drug

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

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 unresectable or metastatic NSCLC or other solid tumors with MET alterations or dysregulation, including selected primary CNS tumors, receive oral vebreltinib, a selective MET tyrosine-kinase inhibitor. Patients with EGFR-mutant NSCLC and acquired MET amplification after initial benefit from first-line EGFR inhibition receive vebreltinib added to their EGFR inhibitor.

ClinicalTrials.gov ID: NCT03175224

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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.

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.

TrialFetch AI summary: Adults with previously treated, progressive recurrent or metastatic solid tumors across 13 cohorts receive intravenous ifinatamab deruxtecan, generally every 3 weeks. This investigational antibody–drug conjugate targets B7-H3 (CD276) and delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06330064

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

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.

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.

TrialFetch AI summary: Adults with ECOG 0–1 and previously treated, refractory, locally advanced unresectable or metastatic solid tumors across multiple tumor-specific cohorts receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks. This investigational HER3-targeted antibody–drug conjugate delivers an exatecan-derived topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06172478

A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma

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.

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.

TrialFetch AI summary: Adults with unresectable or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma after one prior metastatic treatment line, or recurrence during or within six months of perioperative therapy, receive ramucirumab plus paclitaxel with investigational agenT-797 (CD1d-directed invariant natural killer T cells), botensilimab (Fc-enhanced anti-CTLA-4), and balstilimab (anti-PD-1).

ClinicalTrials.gov ID: NCT06251973

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

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.

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic ESCC who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor are randomized to ifinatamab deruxtecan or investigator’s choice of docetaxel, paclitaxel, or irinotecan. Ifinatamab deruxtecan is an investigational B7-H3–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06644781

An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1

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.

Active drug

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

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: For patients with previously untreated, unresectable recurrent or metastatic HPV16-positive HNSCC with PD-L1 combined positive score ≥1, this trial compares pembrolizumab alone with pembrolizumab plus BNT113. BNT113 is an investigational mRNA vaccine encoding HPV16 E6 and E7 that aims to stimulate tumor-directed T-cell responses.

ClinicalTrials.gov ID: NCT04534205

Phase II of Avutometinib (VS-6766) and Defactinib In RAF Dimer-Driven RAI-Refractory Differentiated and Anaplastic Thyroid Cancer Patients

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.

Active drug

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

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 a qualifying RAS, NF1, RET, NTRK, ALK, or class 2/3 BRAF alteration and either progressive, radioiodine-refractory recurrent/metastatic differentiated thyroid cancer or anaplastic thyroid cancer receive avutometinib plus defactinib. Avutometinib is a RAF/MEK clamp that suppresses ERK signaling; defactinib inhibits FAK/PYK2.

ClinicalTrials.gov ID: NCT06007924

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations

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.

Active drug

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

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: Patients aged ≥10 years with advanced solid tumors or recurrent or progressive primary CNS tumors harboring eligible BRAF fusions or BRAF V600E mutations receive plixorafenib, an oral inhibitor of BRAF V600 signaling and BRAF-containing dimers. Depending on the tumor cohort, plixorafenib is given alone or with cobicistat to increase plixorafenib exposure; patients with metastatic cutaneous melanoma or thyroid cancer are randomized between these regimens.

ClinicalTrials.gov ID: NCT05503797