NCT05743777

PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma

A Phase II Study of PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The usual approach for patients who are not in a study is treatment with pembrolizumab, a type of immunotherapy drug. Immunotherapy works by allowing the immune system to detect your cancer and reactivate the immune response. This may help to slow down the growth of cancer and may cause cancer cells to die.

Detailed description

This study is being done to answer the following question: Can the addition of a new treatment improve the cancer-shrinking ability of the usual treatment in patients with advanced head and neck cancer? This study is being done in order to find out if this approach is better or worse than the usual approach for advanced head and neck cancer. The usual approach is defined as the care most people get for advanced head and neck cancer.

Conditions

• Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	400 mg IV q6 weekly for a maximum of 18 cycles
DRUG	MET-4	Cycle 1: 5 g (10 capsules) on days -7 and -6 and 1.5 g (3 capsules) on day -5 and every day thereafter Cycle 2 onwards: 1.5 g (3 capsules) daily
DRUG	Placebo	Cycle 1: 5 g (10 capsules) on days -7 and -6 and 1.5 g (3 capsules) on day -5 and every day thereafter Cycle 2 onwards: 1.5 g (3 capsules) daily

Timeline

• Start date: 2023-05-12
• Primary completion: 2023-05-12
• Completion: 2023-05-12
• First posted: 2023-02-24
• Last updated: 2023-05-18

Regulatory

• FDA-regulated drug study