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A Phase II, Multicenter, Randomized Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (ERBIOTAX)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514953-31-00
Acronym
TTCC-2022-02
Enrollment
65
Registered
2025-02-25
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Brief summary

Confirmed objective response rate (ORR) according to RECIST V1.1 criteria

Detailed description

DCR, Median PFS, Median OS, Health-related quality of life (HRQoL), assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) version 3, the head and neck specific module QLQ-H&N35 and EuroQol EQ-5D., Frequency and severity of adverse events and Treatment-related adverse events (TRAEs) assessed by NCI CTCAE v5.0, Rate of completion of C2D8, C4D8 and C6D8 of Cetuximab +/- Paclitaxel

Interventions

DRUGErbitux 5 mg/mL solution for infusion
DRUGPaclitaxel Teva 6 mg/ml concentrado para solución para perfusión EFG

Sponsors

Grupo Espanol De Tratamiento De Tumores De Cabeza Y Cuello
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Confirmed objective response rate (ORR) according to RECIST V1.1 criteria—

Secondary

MeasureTime frame
DCR, Median PFS, Median OS, Health-related quality of life (HRQoL), assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) version 3, the head and neck specific module QLQ-H&N35 and EuroQol EQ-5D., Frequency and severity of adverse events and Treatment-related adverse events (TRAEs) assessed by NCI CTCAE v5.0, Rate of completion of C2D8, C4D8 and C6D8 of Cetuximab +/- Paclitaxel—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026