Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

Patients with disease that is suitable for local therapy administered with curative intent.
Patients with progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
Patients with persisting toxicity related to prior therapy Grade \>2 constituting a safety risk based on the investigator's judgement.
Patients with a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption.
Patients currently participating and receiving study therapy, or that have participated in a study of an investigational agent and received study therapy, or used an investigational device, any of which occurred within 4 weeks of the first dose of treatment.
Patients with life expectancy of less than 3 months and/or that have rapidly progressing disease (e.g. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
Patients with diagnosis of immunodeficiency or that are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Corticosteroid use as pre-medication for allergic reactions (e.g. IV contrast) is allowed. The use of physiologic doses of corticosteroids (e.g.: prednisone ≤10 mg/days) is allowed.
Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years. Other exceptions may be considered with CCTG consultation.
Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Patients with active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Patients with allogeneic tissue/solid organ transplant.
Patients with active infection requiring systemic therapy.
Patients that have had prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or any other immune compounds.
Patients with known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Subjects with well controlled Human Immunodeficiency Virus (HIV) are allowed.
Patients that have received live vaccine within 30 days of planned start of study therapy. COVID19 vaccination will be allowed and should be recorded as concomitant medication.
+2 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Pembrolizumab + MET-4

Pembrolizumab + Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Pembrolizumab + MET-4

Pembrolizumab + Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record