Clinical Trials for Head And Neck Cancer

A Phase II Study of ACR-368 and Low Dose Gemcitabine Combination Therapy in Patients With Recurrent and/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

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 single-arm study enrolls patients with measurable recurrent or metastatic head and neck squamous cell carcinoma and ECOG performance status 0–1, generally after PD-1/PD-L1 therapy, in separate p16/HPV-positive and -negative cohorts. Patients receive low-dose gemcitabine plus prexasertib (ACR-368), an investigational CHK1/CHK2 inhibitor that disrupts the response to DNA damage and replication stress.

ClinicalTrials.gov ID: NCT06597565

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 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

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 measurable recurrent or advanced/metastatic hepatocellular, cervical, melanoma, head and neck squamous, platinum-resistant high-grade serous ovarian, or non-small cell lung cancer and ECOG 0–1 receive DB-1311, a B7-H3–targeted topoisomerase I inhibitor antibody–drug conjugate. It is combined with either BNT327, a PD-L1/VEGF-A bispecific antibody, or DB-1305, a TROP2-targeted topoisomerase I inhibitor antibody–drug conjugate.

ClinicalTrials.gov ID: NCT06953089

A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy

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 recurrent or metastatic head and neck squamous cell carcinoma that has progressed after immune checkpoint inhibitor therapy receive oral NRC-2694-A, an investigational EGFR tyrosine kinase inhibitor, plus intravenous paclitaxel. Prior taxane or EGFR-targeted therapy for recurrent or metastatic disease is excluded.

ClinicalTrials.gov ID: NCT05283226

Neoadjuvant REGN2810 (Cemiplimab) or REGN2810 (Cemiplimab) Plus REGN3767 (Fianlimab) in Cutaneous Basal Cell Carcinoma of the Head and Neck

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 locally advanced head and neck basal cell carcinoma that is unresectable or would require highly morbid surgery receive neoadjuvant cemiplimab (anti–PD-1) alone or with investigational fianlimab (anti–LAG-3) before surgery. Prior immunotherapy or hedgehog inhibitor treatment for malignancy is excluded.

ClinicalTrials.gov ID: NCT05929664

A Multicenter, Open-label, Randomized Phase 2 Study Evaluating Continuous Weekly Dosing of Ficerafusp Alfa (BCA101) in Combination With Pembrolizumab Versus an Alternative Ficerafusp Alfa Dosing Regimen for First-Line Treatment of 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

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 untreated, PD-L1–positive (CPS ≥1) recurrent or metastatic HNSCC, including HPV-negative oropharyngeal cancer, receive ficerafusp alfa plus pembrolizumab. After 12 weeks of weekly ficerafusp alfa, patients without progression are randomized to every-3-week or continued weekly ficerafusp alfa maintenance; ficerafusp alfa targets EGFR and traps TGF-β.

ClinicalTrials.gov ID: NCT07807163

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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 recurrent IDH-mutant astrocytoma or IDH-wildtype glioblastoma after radiation-based treatment receive oral NEO212 alone; patients with selected solid tumors and brain metastases uncontrolled by surgery or radiation receive it with tumor-appropriate standard-of-care therapy. NEO212 is an investigational temozolomide–perillyl alcohol conjugate that acts as a DNA-alkylating agent.

ClinicalTrials.gov ID: NCT06047379

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With 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

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.

TrialFetch AI summary: Patients with unresectable or metastatic melanoma, recurrent or metastatic head and neck squamous cell carcinoma, or stage III–IV non-small cell lung cancer receive autologous tumor-infiltrating lymphocytes (lifileucel/LN-144, LN-145, or PD-1-selected LN-145-S1) after lymphodepleting chemotherapy, followed by aldesleukin. Depending on the cohort, treatment is given alone or with checkpoint inhibitors; some frontline lung cancer cohorts also receive platinum-doublet chemotherapy plus pembrolizumab.

ClinicalTrials.gov ID: NCT03645928

Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors

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 metastatic or unresectable breast or gastrointestinal cancer that has progressed after standard therapy and expresses HER2 or EGFR receive B-Vaxx, a two-peptide HER2 vaccine emulsified in ISA 720 adjuvant. The peptides mimic HER2 sites targeted by trastuzumab and pertuzumab and are designed to induce HER2-binding antibodies.

ClinicalTrials.gov ID: NCT06414733

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select 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

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.

TrialFetch AI summary: Adults with ECOG 0–1, measurable disease, and an injectable, biopsiable lesion may enroll in cohorts for untreated PD-L1-positive advanced head and neck squamous-cell carcinoma or advanced melanoma progressing on or after anti-PD-(L)1 therapy; the previously treated, non–MSI-high advanced colorectal cancer cohort is closed. Treatment combines intratumoral VV1, an engineered oncolytic virus designed to kill tumor cells and stimulate immunity, with intravenous cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT04291105

A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers

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

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.

TrialFetch AI summary: Adults with measurable metastatic or recurrent/refractory HPV16-positive cancer who are HLA-A*02:01-positive and have received or declined standard therapy receive cyclophosphamide/fludarabine lymphodepletion, followed by a single infusion of autologous TCR-engineered T cells targeting HPV16 E7 presented by HLA-A*02:01 and adjuvant aldesleukin.

ClinicalTrials.gov ID: NCT05686226