We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05743777
Recruitment Status : Withdrawn (Company withdrew financial support)
First Posted : February 24, 2023
Last Update Posted : May 18, 2023
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Head and Neck Squamous Cell Carcinoma Drug: Pembrolizumab Drug: MET-4 Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Study of PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : May 12, 2023
Actual Primary Completion Date : May 12, 2023
Actual Study Completion Date : May 12, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pembrolizumab + MET-4 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

Active Comparator: Pembrolizumab + Placebo Drug: Pembrolizumab
400 mg IV q6 weekly for a maximum of 18 cycles

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

Primary Outcome Measures :
  1. Objective Response Rate per RECIST 1.1 in first line recurrent and/or metastatic (R/M) HNSCC subjects, treated with pembrolizumab in combination with MET-4 or pembrolizumab with placebo. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Progression-free survival as per RECIST 1.1 [ Time Frame: 3 years ]
  2. Overall survival [ Time Frame: 3 years ]
  3. Duration of response [ Time Frame: 3 years ]
  4. Number and severity of adverse events per CTCAE version 5.0 [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically-confirmed R/M HNSCC considered incurable by local therapies.
  • Patients must not have had any prior systemic therapy administered in the recurrent or metastatic setting.
  • Patients with prior systemic therapy given as part of multimodal treatment for locoregionally advanced disease must have completed treatment > 6 months prior to signing consent.
  • Patients must have one of the following primary tumor locations: oropharynx, oral cavity, hypopharynx, and larynx. Primary tumor site of nasopharynx (any histology) is excluded.
  • Patients with oropharyngeal cancer, must have Human Papilloma Virus (HPV) status determined by p16 immunohistochemical staining on a tumor specimen. Local testing is acceptable.
  • Patients must be at least 18 years of age on day of signing informed consent.
  • Patients must have measurable disease based on RECIST 1.1 as determined by the site. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Patients must have an ECOG performance status of 0 or 1
  • Abs neutrophil count ≥1,500/μL; Platelets ≥ 100,000; Hemoglobin ≥9 g/dL; Creatinine or measured or calculated creatinine clearance ≤ 1.5 x UNL or ≥ 30mL/min for subject with creatinine levels > 1.5 x UNL; Total bilirubin ≤ 1.5 x UNL or Direct bilirubin ≤ UNL for subjects with total bilirubin levels > 1.5 x ULN; ALT ≤ 2.5 UNL or ≤ 5 x UNL for subjects with liver metastases
  • Patients must have PD-L1 positive (CPS ≥1) tumor as determined by PD-L1 testing performed at the local laboratory, from a core or excisional biopsy (fine needle aspirate is not adequate).
  • Patients must consent to provision of samples of blood, oropharyngeal swab, and stool for correlative marker analysis.
  • Patients must consent to the submission of, and investigator must confirm access to and agree to submit within 4 weeks of enrollment, a formalin-fixed, paraffin-embedded tumour (FFPE) tissue block, cores (two 2 mm cores of tumour from the block), or 10-15 freshly cut unstained tumour slides (4 µm thick) for protocol-mandated exploratory assessments.
  • Patient must be able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
  • Women of childbearing potential must have a negative blood pregnancy test within 72 hours prior to receiving the first dose of study medication to confirm eligibility as part of the Pre-Study Evaluation
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method starting with first dose of study therapy through 180 days after the last dose of study therapy
  • Patients must be able to swallow oral medications.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.

Exclusion Criteria:

  • 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.
  • Patients with history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Patients that are pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05743777

Sponsors and Collaborators
Canadian Cancer Trials Group
Layout table for investigator information
Study Chair: Anna Spreafico University Health Network, Princess Margaret Cancer Centre, Toronto ON Canada
Layout table for additonal information
Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT05743777    
Other Study ID Numbers: HN12
First Posted: February 24, 2023    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action