BridgeMD
New treatment option for Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma...
Official title Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
ClinicalTrials.gov ID: NCT06636734
What this study is testing
What is Lovastatin?
Lovastatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clinical stage iv hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Also referred to as Lovastatin Sodium, Mevacor.
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
- This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
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
- Adult patients, male or female, aged ≥ 18, able to provide informed consent
- people with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx...
- PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)
- Patients must not be under consideration for salvage surgery
- Measurable disease by RECIST 1.1 criteria
You likely can't join if
- Patients already taking a statin drug
- Liver dysfunction precluding the use of statins
- Radiation to the head and neck or other sites within 4 weeks prior to enrollment
- Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment
- Prior treatment with immune checkpoint blocking therapy
- Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)
See the full eligibility criteria
- Adult patients, male or female, aged ≥ 18, able to provide informed consent
- people with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or paranasal sinuses; patients with...
- PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)
- Patients must not be under consideration for salvage surgery
- Measurable disease by RECIST 1.1 criteria
- Life expectancy of more than 3 months, as determined by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 from toxicities related to any prior treatments, unless adverse events are clinically non-significant and/or...
- For men or women of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks...
- Absolute neutrophil count (ANC) ≥ 1000/mm\^3 without colony stimulating factor support
- Platelets ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For people with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL
- Serum albumin ≥ 2.8 g/dl
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN
- Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)
- Patients already taking a statin drug
- Liver dysfunction precluding the use of statins
- Radiation to the head and neck or other sites within 4 weeks prior to enrollment
- Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment
- Prior treatment with immune checkpoint blocking therapy
- Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)
- Pregnancy, lactation, or plan to become pregnant
- Inability to swallow lovastatin tablets
- Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Atlanta, Georgia, United States. 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.