CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 150 target
Drug / intervention
Pembrolizumab combined with Chemotherapydrug
Likely dose
Not stated in record
Key inclusion· 7
  • Age 18-75 years old
  • ECOG performance status 0-1
  • Histologically or cytologically confirmed head squamous cell carcinoma from oral cavity, oropharynx, hypopharynx or larynx
  • Recurrent and/or metastatic HNSCC without indications for local radical treatment
Key exclusion· 20
  • Suitable for local treatment and willing to receive local treatment
  • Prior systemic chemotherapy (except multimodal therapy completed >6 months before first dose)
  • Disease progression within 6 months of completing multimodal therapy for locally advanced HNSCC
  • Prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies or other T cell co-stimulation or immune checkpoint pathway therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04857164
NCT04857164Phase 2RecruitingUpdate OverdueUpdated 17mo ago · Completion was 34mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

A Prospective Study of Pembrolizumab Combined with Chemotherapy (cisplatin or Carboplatin + Albumin-bound Paclitaxel) in First-line Therapy for Patients with Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Yuankai Shi·interventional·Posted Apr 23, 2021·Updated Jan 28, 2025

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab combined with Chemotherapy for Head and Neck Squamous Cell Carcinoma. Currently recruiting, targeting 150 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
20222023202420252026
First PostedApr 23, 2021
Enrollment StartApr 30, 2021
Primary CompletionAug 20, 2023
Study CompletionJan 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.2 years ago

Interventions

Pembrolizumab combined with Chemotherapydrug

Pembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer Chemotherapy regimen is selected by the investigator immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer.