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Advanced Head and Neck Squamous Cell CarcinomaPhase 2PROMOTE-HNNCT05743777

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

A Phase 2 study testing Pembrolizumab and MET-4 in people with Advanced Head and Neck Squamous Cell Carcinoma, run by Canadian Cancer Trials Group.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab and MET-4
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
12 May 2023to 12 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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.

Read the 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.

Being tested
Pembrolizumab, MET-4, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    400 mg IV q6 weekly for a maximum of 18 cycles

  • MET-4Drug

    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

  • PlaceboDrug

    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

Study groups in NCT05743777
Study groupRoleWhat they receive
Pembrolizumab + MET-4ExperimentalNot described
Receives: Drug: Pembrolizumab; Drug: MET-4
Pembrolizumab + PlaceboActive comparatorNot described
Receives: Drug: Pembrolizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (4)

  1. Progression-free survival as per RECIST 1.1

    Measured: 3 years

  2. Overall survival

    Measured: 3 years

  3. Duration of response

    Measured: 3 years

  4. Number and severity of adverse events per CTCAE version 5.0

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start12 May 2023
  3. Primary completion12 May 2023
  4. Study completion12 May 2023

Why it stopped: Company withdrew financial support

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05743777
Sponsor's protocol ID
HN12
Acronym
PROMOTE-HN
Status last verified
May 2023
First submitted
9 Feb 2023
Last updated
18 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and MET-4 in people with Advanced Head and Neck Squamous Cell Carcinoma, run by Canadian Cancer Trials Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05743777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

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