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. More on methods

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

• Papers screened out: n = 462

• Papers included for extraction: n = 38

Paper search

Using your research question “phase 3 metastatic squamous cell carcinoma of head and neck that started after 2015 that are also interventional and industry sponsored”, we searched across all trials from the ClinicalTrials.gov corpus. We retrieved the 500 trials most relevant to the query.

Screening

We screened in sources based on their abstracts that met these criteria:

• Population - Cancer Type: Does the study specifically focus on patients with squamous cell carcinoma of head and neck (HNSCC)?
• Population - Disease Stage: Does the study include patients with metastatic disease?
• Study Design - Trial Phase: Is this a Phase 3 clinical trial?
• Study Design - Type: Is this an interventional study?
• Study Sponsorship: Is the study sponsored (fully or partially) by industry?
• Study Timeline: Did the study start on or after January 1, 2015?
• Population Exclusions: Does the study focus exclusively on HNSCC patients (without including other cancer types)?

We considered all screening questions together and made a holistic judgment about whether to screen in each paper.

Data extraction

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

Study Type and Phase

• Study Type: Interventional
• Phase: Phase 3 or Phase 2/3

Sponsorship Details

• Primary Sponsor: Identify primary industry sponsor or note "Not specified".

Participant Eligibility Criteria

• Extract key inclusion and exclusion criteria specific to metastatic squamous cell carcinoma, age range, performance status, and prior treatments.

Geographical Locations

• List all countries where the study is being conducted.

Primary Intervention

• Describe the primary intervention in detail including specific drugs, treatments, dosage, and administration method.

Results

Characteristics of Included Studies

Summary of intervention types:

• Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/PD-L1) agents: 15 studies.
• Anti-PD-1/PD-L1 agents with novel immunotherapies: 12 studies.
• Anti-PD-1/PD-L1 agents with tyrosine kinase inhibitors: 2 studies.
• Anti-EGFR (cetuximab) in combination regimens: 4 studies.

Summary of trial status:

• 9 studies were recruiting.
• 1 study was active, not recruiting.
• 5 studies were completed, results available.

Summary of primary endpoints:

• 17 studies listed efficacy and safety as primary endpoints.

Discussion

• We identified a large number of phase 3, interventional, industry-sponsored trials in metastatic Head and Neck Squamous Cell Carcinoma 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.
• Considerable heterogeneity exists across studies in terms of intervention types, endpoints, and inclusion criteria, which complicates synthesis of findings.