BridgeMD
New treatment option for Head & Neck Squamous Cell Carcinoma
Official title Effect of Postbiotics on Microbiota and Systemic Immunomodulation of Pembrolizumab as First-Line Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)
ClinicalTrials.gov ID: NCT07485296
What this study is testing
What is Pembolizumab?
Pembolizumab is an investigational medicine, being studied as a potential treatment for head & neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- phase II, randomized, double-blind, placebo controlled, non pharmacological clinical trial that aims to determine the effect of postbiotics Postbiotix-HLA™ on immuno-related adverse events (irAEs) in patients with recurrent/metastatic head and neck squamous cell carcinoma (RM HNSCC) treated with in first line pembrolizumab as standard of care (SoC). The selected patient population will be randomised to receive the postbiotics Postbiotix-HLA™ or placebo for 4 cycles while in treatment with pembrolizumab as per clinical practice.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- -1. Be willing and able to provide informed consent for the trial and its procedure;
- Histological confirmation of HNSCC;
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) HNSCC;
- For oropharyngeal cancers, known IHC p16+ and/or ISH HPV status;
- Positive PD-L1 Combined Proportionate Score (CPS);
You likely can't join if
- Presence of untreated brain metastases. Patients with treated brain metastases must be stable for 4 weeks after completion of treatment and have...
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting...
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10...
- Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
- Current use, or intent to use, probiotics, yogurt or bacterial fortified foods during the period of treatment.
- Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within...
See the full eligibility criteria
Who can join
- -1. Be willing and able to provide informed consent for the trial and its procedure;
- Histological confirmation of HNSCC;
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) HNSCC;
- For oropharyngeal cancers, known IHC p16+ and/or ISH HPV status;
- Positive PD-L1 Combined Proportionate Score (CPS);
- Presence of neoplastic lesion deemed safely accessible for tumor biopsy by the investigator;
- No prior systemic therapy for RM HNSCC;
- Eligible to receive pembrolizumab as the standard of care
- ECOG Performance Status ≤ 2;
- Measurable disease as per RECIST 1.1;
- Males and females, ages ≥18;
- Adequate renal function defined as calculated creatinine clearance ≥30 milliliters per minute (mL/min) per the Cockcroft and Gault formula or Serum creatinine \< 1.5 x upper limit of normal (ULN);
- Adequate liver function defined by AST or ALT \< 3 x ULN (\< 5 x ULN if liver metastases are present), and total bilirubin \< 1.5 x ULN (except people with Gilbert Syndrome, who can have total bilirubin up to 3.0 mg/dL);
- Adequate bone marrow function defined by any of the following laboratory test findings: - WBC \> 2,000/mm3, Neutrophils \> 1,500/mm3, Platelets \> 100,000/mm3;
- Female people of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Female people of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 6.3 and 6.4 - Contraception, for the course of the study through 120 days after the last dose of...
- Male people of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.3 and 6.4 - Contraception, starting with the first dose of study therapy through 120 days after the...
What rules you out
- Presence of untreated brain metastases. Patients with treated brain metastases must be stable for 4 weeks after completion of treatment and have documented stability on pre-study imaging. Patients must have no clinical...
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10 mg daily prednisone equivalent) or immunosuppressive medications...
- Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
- Current use, or intent to use, probiotics, yogurt or bacterial fortified foods during the period of treatment.
- Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and...
- Uncontrolled adrenal insufficiency.
- Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration...
- Not recovered to ≤ Grade 1 toxicities related to any prior therapy before administration of study drug.
- Women who are pregnant or breastfeeding.
- History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled...
- Any of the following laboratory test findings:
- WBC \< 2,000/mm3
- Neutrophils \< 1,500/mm3
- Platelets \< 100,000/mm3
- AST or ALT \> 3 x ULN (\> 5 x ULN if liver metastases are present)
- Total bilirubin \> 1.5 x ULN (except people with Gilbert Syndrome, who can have total bilirubin 3.0 mg/dL)
- Calculated creatinine clearance \ 1.5 x upper limit of normal (ULN)
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has a known history of active TB (Bacillus Tuberculosis)
- Has previously received an organ transplant
- Has previously received bone marrow transplantation
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines...
The study team makes the final eligibility decision.
Where it's taking place
- Rozzano, Milano, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rozzano, Milano, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.