Clinical Trials for Head And Neck Cancer

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

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.

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

ClinicalTrials.gov ID: NCT06760819

A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/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

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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors in three cohorts: recurrent/metastatic cervical cancer after 1–2 prior lines; recurrent/metastatic HNSCC (including PD-L1–positive, systemic-therapy–naive or platinum-refractory); and untreated R/M HNSCC receive volrustomig, a bispecific PD-1/CTLA-4 antibody, as monotherapy or combined with chemo (carboplatin/paclitaxel or 5-FU plus platinum). Excludes prior checkpoint inhibitor exposure and requires ECOG 0–1 and PD-L1 testing; endpoints include ORR and safety per RECIST 1.1.

ClinicalTrials.gov ID: NCT06535607

A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (I-MAC)

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.

HealthScout AI summary: Adults with recurrent/metastatic or unresectable salivary gland carcinoma (any histology, including adenoid cystic), ECOG 0–1, measurable non-CNS disease, and no prior PD‑1 or VEGFR TKI therapy receive ivonescimab every 21 days; treated/stable brain metastases allowed. Ivonescimab is a bispecific tetravalent antibody targeting PD‑1 and VEGF to combine immune checkpoint blockade with anti‑angiogenesis.

ClinicalTrials.gov ID: NCT06805617

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma

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.

HealthScout AI summary: Adults with PD-L1 CPS ≥1 recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, larynx) without prior systemic therapy for incurable disease are randomized to petosemtamab plus pembrolizumab vs pembrolizumab alone. Petosemtamab (MCLA-158) is a bispecific IgG1 targeting EGFR and LGR5 that blocks EGFR signaling and promotes EGFR internalization in LGR5+ tumor cells with Fc-mediated ADCC/ADCP.

ClinicalTrials.gov ID: NCT06525220

Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin-3 Inhibitor (GB1211) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

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.

HealthScout AI summary: Adults with unresectable/metastatic melanoma (including mucosal/unknown primary; treatment-naïve allowed) or recurrent/metastatic HNSCC after platinum therapy are randomized to pembrolizumab plus GB1211 vs pembrolizumab plus placebo. GB1211 (selvigaltin) is an oral selective galectin‑3 inhibitor aimed at reversing immune suppression and resistance to PD‑1 blockade; prior PD‑1/PD‑L1 allowed if ≥6 months since last dose with progression; key exclusions include active autoimmune disease and untreated brain mets.

ClinicalTrials.gov ID: NCT05913388

A Phase 2 Platform Study of Novel Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma

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.

HealthScout AI summary: First-line study for adults with recurrent/metastatic, non-nasopharyngeal HNSCC (ECOG 0–1, measurable disease, no prior PD-1/TIGIT; prior curative-intent platinum allowed if relapse >6 months) comparing zimberelimab (anti–PD-1) plus carboplatin/paclitaxel with or without domvanalimab, an Fc-silent anti-TIGIT antibody that augments T-cell activity. Aims to determine whether adding anti-TIGIT to PD-1 blockade and platinum-taxane chemotherapy improves ORR and PFS.

ClinicalTrials.gov ID: NCT06727565

A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-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.

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.

HealthScout AI summary: Adults with recurrent/metastatic HPV-negative HNSCC after prior PD-1/PD-L1 inhibitor and platinum therapy (ECOG 0–1) are randomized to cetuximab plus ficlatuzumab vs cetuximab plus placebo. Ficlatuzumab is an anti-HGF monoclonal antibody that blocks HGF/MET signaling; prior EGFR inhibitor in the R/M setting is excluded.

ClinicalTrials.gov ID: NCT06064877

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.

HealthScout AI summary: Adults with RAF dimer–driven thyroid cancers: RAIR differentiated (papillary/follicular/Hürthle cell/poorly differentiated) with recent progression or anaplastic, harboring RAS or NF1 mutations, RET/NTRK/ALK fusions, or non‑V600E/K/class 2–3 BRAF alterations; ECOG 0–1, measurable disease, any prior lines, but no prior MEK/class II–III BRAF/FAK inhibitors. Treatment is oral avutometinib (dual RAF/MEK clamp) plus defactinib (FAK/Pyk2 inhibitor) on a 3-weeks-on/1-week-off schedule, with ORR as the primary endpoint.

ClinicalTrials.gov ID: NCT06007924

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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.

HealthScout AI summary: Adults with PD-L1 CPS ≥1 recurrent or metastatic HNSCC (oral cavity, hypopharynx, larynx, or HPV-negative oropharynx), no prior systemic therapy for R/M disease, are randomized to pembrolizumab plus ficerafusp alfa (BCA101) vs pembrolizumab plus placebo. Ficerafusp alfa is a tumor-targeted bifunctional IgG1 that inhibits EGFR and locally traps TGF-β to enhance antitumor immunity; exclusions include active CNS mets, recent ICI, prior anti–TGF-β, most prior anti-EGFR mAbs, and autoimmune disease requiring systemic therapy.

ClinicalTrials.gov ID: NCT06788990

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.

HealthScout AI summary: Enrolling patients ≥10 years (≥30 kg) with unresectable/metastatic solid tumors or recurrent/progressive primary CNS tumors harboring qualifying BRAF alterations (class 1 V600E or class 2 incl. fusions), across cohorts for BRAF fusions, V600E CNS tumors, and selected rare V600E non‑CNS tumors; excludes NF1/activating RAS and prior MAPK inhibitors in most cohorts. Treatment is oral plixorafenib (PLX‑8394), a selective BRAF inhibitor that disrupts RAF dimer signaling and avoids paradoxical ERK activation, given alone or with cobicistat boosting depending on cohort.

ClinicalTrials.gov ID: NCT05503797