Elicit: Interventional Trials in Metastatic Head and Neck SCC (CT, public)

Interventional Trials in Metastatic Head and Neck SCC (CT, public)

phase 3 metastatic squamous cell carcinoma of head and neck that started after 2015 that are also interventional and industry sponsored

Twenty-one phase 3, interventional, industry-sponsored trials in metastatic head and neck squamous cell carcinoma have been initiated since 2015, with varying current status ranging from recruiting to terminated.

Abstract

Twenty-one phase 3, interventional, industry‐sponsored trials in metastatic head and neck squamous cell carcinoma initiated after 2015 have been registered. Fifteen trials evaluate anti–PD-1/PD-L1 agents as single agents or in combination, while 12 assess these agents paired with novel immunotherapies (for example, bispecific antibodies, vaccines, fusion proteins) or with tyrosine kinase inhibitors, chemotherapy, or anti–EGFR therapy.

Seventeen studies list overall survival, progression-free survival, and response rate as primary endpoints but have not reported results. No study has detailed quantitative safety outcomes such as grade 3–4 adverse events or treatment discontinuations. Enrollment is often limited by biomarker criteria (eg, PD-L1 Combined Positive Score thresholds or HPV16 positivity), although subgroup data are not available. Among the trials, nine are recruiting, one is active but not recruiting, two are active with published results, five have completed with available results, and three were terminated with results reported.

Methods

We analyzed 38 sources from an initial pool of 500, using 7 screening criteria. Each paper was reviewed for 5 key aspects that mattered most to the research question.

Papers identified with Elicit search

n = 500

Papers screened using: Population - Cancer Type, Population - Disease Stage, Study Design - Trial Phase, Study Design - Type, Study Sponsorship, Study Timeline, Population Exclusions

n = 500

Papers screened out

n = 462

Papers included for extraction

n = 38

Data extraction

We asked a large language model to extract each data column below from each paper.

Study Type and Phase: Extract the specific study type (e.g., interventional) and exact phase (e.g., Phase 3) as listed in the clinical trial registration or methods section. If multiple phases are mentioned (e.g., Phase 2/3), record both.
Sponsorship Details: Identify the primary sponsor of the study. Look for:
- Industry sponsor name
- Funding source
- Sponsoring organization
Participant Eligibility Criteria: Extract key inclusion and exclusion criteria specific to:
- Disease stage (metastatic squamous cell carcinoma)
- Age range
- Performance status
- Prior treatments
Geographical Locations: List all countries where the study is being conducted.
Primary Intervention: Describe the primary intervention in detail:
- Specific drugs/treatments used
- Combination therapies
- Dosage (if specified)
- Administration method

Results

Characteristics of Included Studies

Study ID	Intervention Type	Primary Endpoints	Trial Status
Merck Sharp & Dohme LLC, 2025a	Pembrolizumab (neoadjuvant and adjuvant) + radiotherapy with or without cisplatin	Event-free survival	Active, not recruiting
AVEO Pharmaceuticals, Inc., 2025	Ficlatuzumab + cetuximab vs placebo + cetuximab	Efficacy (Overall Survival, Progression-Free Survival), safety	Recruiting
Merus N.V., 2025a	Petosemtamab + pembrolizumab vs pembrolizumab	Efficacy, safety	Recruiting
Merus N.V., 2025b	Petosemtamab vs investigator’s choice monotherapy	Efficacy, safety	Recruiting
...	...	...	...

Summary of intervention types

Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/PD-L1) agents: Found in 15 studies, either alone or in combination.
Anti-PD-1/PD-L1 agents with novel immunotherapies: 12 studies tested combinations with bispecific antibodies, vaccines, fusion proteins, anti-Inducible T-cell COStimulator (ICOS), anti-NKG2A, interleukin-2 (IL-2) agonist, or indoleamine 2,3-dioxygenase (IDO) inhibitor.
...

Summary of primary endpoints

17 studies listed efficacy and safety as primary endpoints.
1 study listed event-free survival as the primary endpoint.
...

Discussion

We identified a large number of phase 3, interventional, industry-sponsored trials in metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) initiated after 2015, with a strong focus on immunotherapy and combination regimens.
The absence of mature efficacy and safety data from most studies limits the ability to draw conclusions regarding comparative effectiveness or tolerability.