Clinical Trials for Head And Neck Cancer

Phase I Trial of CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer

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.

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: First-line treatment for adults with unresectable/metastatic gastric, GEJ, or esophageal adenocarcinoma or squamous cell carcinoma (ECOG 0–1), testing oral IRAK4 inhibitor emavusertib (CA‑4948; targets TLR/IL‑1R→NF‑κB signaling, with FLT3/CLK activity) added to mFOLFOX7 plus PD‑1 blockade. HER2‑negative patients receive emavusertib + mFOLFOX7 + nivolumab; HER2‑positive patients receive emavusertib + mFOLFOX7 + pembrolizumab + trastuzumab.

ClinicalTrials.gov ID: NCT05187182

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

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.

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 unresectable esophageal squamous cell carcinoma who progressed after one prior platinum regimen that included PD‑1/PD‑L1 therapy; compares standard second-line paclitaxel or irinotecan versus investigational sacituzumab tirumotecan (TROP2-directed topoisomerase I ADC), with previously planned pembrolizumab/MK‑4830 combinations closed to enrollment. Primary focus is safety and objective response with blinded central review, with secondary endpoints including PFS and OS.

ClinicalTrials.gov ID: NCT05319730

Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer

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.

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 needing palliative RT and with an injectable lesion receive intratumoral RiMO-301 (hafnium-based radioenhancer) plus a PD-1 inhibitor (pembrolizumab or nivolumab) followed by hypofractionated radiotherapy. Suitable for ECOG 0–2 patients eligible for PD-1 therapy; excludes symptomatic CNS disease and active autoimmune conditions requiring recent systemic therapy.

ClinicalTrials.gov ID: NCT05838729

A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

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.

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 recurrent or metastatic HNSCC (ECOG 0–2; controlled CNS mets allowed) receive an investigational multivalent autophagosome vaccine (DPV-001; off‑the‑shelf allogeneic microvesicle vaccine delivering broad tumor antigens to prime dendritic cells/T‑cell responses) followed by sequenced PD‑1 blockade (retifanlimab); a closed arm also tested addition of a GITR agonist (INCAGN01876) to enhance effector T cells and reduce Treg suppression. Excludes active autoimmune disease requiring significant immunosuppression; mandatory biopsies are required.

ClinicalTrials.gov ID: NCT04470024

A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy

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: Single-arm study for adults with recurrent/metastatic HNSCC (oral cavity, oropharynx, hypopharynx, larynx, sinonasal) who progressed after first-line anti–PD-(L)1–based therapy (up to two prior R/M lines), ECOG 0–1. Patients receive sacituzumab govitecan (Trop-2–targeted ADC delivering SN-38/topoisomerase I inhibitor) plus cetuximab (EGFR mAb), with RECIST v1.1 response as primary endpoint.

ClinicalTrials.gov ID: NCT07063212

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

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, resectable oral cavity squamous cell carcinoma (ECOG 0–1) ≥3 months after prior curative therapy receive 6 weeks of neoadjuvant cemiplimab (PD‑1 inhibitor) plus cetuximab (anti‑EGFR), followed by salvage surgery and optional adjuvant cemiplimab up to 1 year. Excludes distant metastases and prior PD‑1/PD‑L1 therapy.

ClinicalTrials.gov ID: NCT06448026

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

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 EBV-associated recurrent/metastatic nasopharyngeal carcinoma who have not progressed after first-line platinum–gemcitabine plus nivolumab induction are randomized to maintenance nivolumab versus nivolumab plus relatlimab. Relatlimab is an anti–LAG-3 immune checkpoint inhibitor combined with PD-1 blockade to enhance antitumor immunity; baseline and post-induction plasma EBV DNA monitoring is required.

ClinicalTrials.gov ID: NCT06029270

A Phase 2 Trial of PD-L1 t-haNK, N-803 IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)

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.

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.

TrialFetch AI summary: Adults with recurrent/metastatic or unresectable HNSCC after 1–2 prior systemic lines including anti–PD-1/L1 receive a triple regimen of PD-L1 t-haNK (allogeneic NK-92–derived CAR-NK targeting PD-L1 with high-affinity CD16 and IL-2 support), N-803 (IL-15 superagonist activating NK/CD8 T cells), and cetuximab. Excludes ≥3 prior R/M lines, active CNS mets, significant immunosuppressed autoimmunity, or active HBV/HCV; imaging every 8 weeks assesses response.

ClinicalTrials.gov ID: NCT06239220

A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors

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.

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/metastatic solid tumors (dose escalation) and recurrent/metastatic head and neck squamous cell carcinoma after platinum and/or PD‑1/PD‑L1 therapy receive CHS‑114, an afucosylated anti‑CCR8 IgG1 designed to deplete intratumoral Tregs, as monotherapy or combined with the PD‑1 inhibitor toripalimab. Key inclusion: measurable disease, ECOG 0–1; HNSCC cohorts exclude nasopharyngeal primary and require tumor tissue; excludes prior anti‑CCR8 therapy and excessive prior lines per cohort.

ClinicalTrials.gov ID: NCT05635643

Phase II Trial of Pulsed Dose Chemotherapy Plus Pembrolizumab in the First Line Treatment of Recurrent/Metastatic HNSCC

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 CPS >1 recurrent/metastatic HNSCC (ECOG 0–2) receive pembrolizumab (anti–PD-1) starting cycle 1 with pulsed carboplatin/paclitaxel added every third pembrolizumab cycle (q9 weeks) for four cycles, then pembrolizumab maintenance. Excludes prior systemic therapy for R/M disease, recent PD-1/PD-L1 in R/M setting, active autoimmune disease requiring treatment, ILD/pneumonitis, or significant neuropathy.

ClinicalTrials.gov ID: NCT06052839