Clinical Trials for Head And Neck Cancer

Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

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 EGFR‑dependent advanced solid tumors—primarily mCRC (RAS/RAF WT, MSS; anti‑EGFR–naive for chemo combos or 3L+ without HER2 amp/oncogenic EGFR ECD mutations) and previously included HNSCC—receive petosemtamab, a bispecific anti‑EGFR/LGR5 IgG1 antibody given Q2W as monotherapy or combined with FOLFOX/FOLFIRI (and previously pembrolizumab in HNSCC). Suitable for ECOG 0–1 patients without uncontrolled CNS disease; aims to exploit EGFR blockade and LGR5‑targeted EGFR degradation with Fc effector function.

ClinicalTrials.gov ID: NCT03526835

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.

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

Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard 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: Adults with metastatic GI adenocarcinomas (colorectal, pancreaticobiliary, or upper GI) progressing after standard therapy receive sacituzumab govitecan (Trop-2–targeted ADC delivering SN-38/topoisomerase I inhibitor) plus capecitabine in 21-day cycles; prior topo I inhibitor exposure is excluded, treated/stable brain mets allowed. Dose-escalation assesses safety/tolerability and seeks an RP2D, with exploratory correlation to tumor Trop-2 expression.

ClinicalTrials.gov ID: NCT06065371

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

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 advanced/metastatic solid tumors requiring at least one injectable lesion (ECOG 0–1) receive intratumoral T3011—an engineered oncolytic HSV‑1 expressing IL‑12 and an anti‑PD‑1 antibody—either as monotherapy in melanoma, HNSCC post‑platinum/PD‑(L)1, sarcoma, or cSCC, or combined with IV pembrolizumab in previously treated metastatic NSCLC without EGFR/ALK alterations. Excludes patients with uninjectable disease, high‑risk injection sites, active autoimmune disease requiring immunosuppression, active HSV, significant cardiopulmonary disease, CNS metastases, or active viral infections.

ClinicalTrials.gov ID: NCT04370587

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

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 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

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.

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

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

A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers

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, metastatic, or unresectable HER2-expressing salivary gland cancers: HER2-positive (IHC 3+ or amplified) randomized to docetaxel + trastuzumab vs trastuzumab emtansine (T-DM1, HER2-directed microtubule-inhibitor ADC) with crossover at progression; HER2-low (IHC 1+ or 2+ without amplification) receive trastuzumab deruxtecan (T-DXd, HER2-directed topoisomerase I inhibitor ADC). Eligible with ECOG 0–2, measurable disease required for HER2-low; treated/stable and select untreated stable brain metastases allowed.

ClinicalTrials.gov ID: NCT05408845

3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial

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 incurable head and neck squamous cell carcinoma (including prior RT/systemic therapy and allowing metastatic disease) are randomized to short-course SBRT in 3–5 fractions versus conventional palliative external-beam radiation. The trial compares symptom relief and local control while monitoring toxicity.

ClinicalTrials.gov ID: NCT05674396

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