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New treatment option for Human Papilloma Virus
Official title Merck IIT: RRP Pembro and Lenvatinib
ClinicalTrials.gov ID: NCT04645602
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for human papilloma virus.
Also referred to as Lenvima.
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 research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP). The names of the study drugs involved in this study are: Pembrolizumab Lenvatinib
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- \- Participants must have histologically or cytologically confirmed respiratory papillomas with radiologic evidence of lung involvement. people can...
- For those patients with non-measurable pulmonary disease, participants must have disease at other sites such as the larynx and trachea and must have...
- Be required to provide tissue from a newly obtained biopsy of a lesion or an archived specimen. Newly-obtained is defined as a specimen obtained up...
- Have confirmed human papillomavirus-associated lesions based on in-situ hybridization testing and/or polymerase chain reaction which may be performed...
- Age ≥18 years.
You likely can't join if
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment. Note: Participants must...
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities...
- Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed...
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the...
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to the first dose of study treatment...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
See the full eligibility criteria
Who can join
- \- Participants must have histologically or cytologically confirmed respiratory papillomas with radiologic evidence of lung involvement. people can have measurable or non-measurable\ pulmonary disease based on RECIST...
- For those patients with non-measurable pulmonary disease, participants must have disease at other sites such as the larynx and trachea and must have undergone \> 3 surgical procedures over a 12-month period.
- Be required to provide tissue from a newly obtained biopsy of a lesion or an archived specimen. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to the first dose of study drug. people for...
- Have confirmed human papillomavirus-associated lesions based on in-situ hybridization testing and/or polymerase chain reaction which may be performed on a newly obtained biopsy or archived sample.
- Age ≥18 years.
- ECOG performance status of 0 to 1.
- Participants must have adequate organ and marrow function as defined below: \---- Absolute neutrophil count (ANC) ≥1500/μL \---- Platelets ≥100 000/μL \---- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (a)
- Creatinine OR Measured or calculated (b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × institutional ULN OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
- Total bilirubin ≤1.5 × institutional ULN OR direct bilirubin ≤ institutional ULN for participants with total bilirubin levels greater than or equal to 1.5× institutional ULN
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × institutional ULN for participants with liver metastases)
- TSH Institutional normal limit
- Free T4 Institutional normal limit
- Amylase less than or equal to 1.5 x institutional ULN
- Lipase less than or equal to 1.5 x institutional ULN
- International normalized ratio (INR) OR prothrombin time (PT)
- Activated partial thromboplastin time (aPTT)
- 1.5 × institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
- Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC)transfusion within last 2 weeks.
- Creatinine clearance (CrCl) should be calculated per institutional standard. -- Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Adequately controlled blood pressure with or without antihypertensive medications defined as systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg at screening with no change in antihypertensive medications within 1 week...
- Female subject of childbearing potential must have a negative serum pregnancy test within 28 days of the first dose of study drug\ . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy...
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a WOCBP as defined below. OR
- Is a WOCBP and must be willing to use 2 methods of birth control, or abstain from heterosexual activity during the intervention period and for at least 120 days after the last dose of pembrolizumab or 30 days post...
- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months (or 120 days) after completion of pembrolizumab
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of Lenvatinib:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
- Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner...
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of...
- Ability to complete Patient Medication and Blood Pressure diaries by themselves or with assistance.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment. Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or...
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to the first dose of study treatment. NOTE: Participants who have entered the follow-up phase of an...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin...
- History of allergic reactions (greater than or equal to Grade 3) attributed to compounds of similar chemical or biologic composition to pembrolizumab or lenvatinib and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. NOTE: No testing for Hepatitis B and Hepatitis C...
- Has a known history of active TB (Bacillus Tuberculosis).
- Has urine protein greater than or equal to 1 g/24 hours. Note: Participants with proteinuria \> 2+ (greater than or equal to100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for...
- Electrolyte abnormalities that have not been corrected.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina...
- Has a LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).
- Prolongation of QTcF interval to \>480 msec, as calculated by either the Bazett or Fridericia formula, as per institutional standard.
- Bleeding or thrombotic disorders or people at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of...
- Has a known history of colitis.
- Has clinically significant gastrointestinal malabsorption syndrome or any other condition that might affect the absorption of lenvatinib.
- Has preexisting greater than or equal to Grade 3 gastrointestinal or non-gastrointestinal fistula
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- Has a known history of posterior reversible encephalopathy syndrome (PRES).
- Participants with history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the...
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. Pregnant...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, 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 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 New Haven, Connecticut, 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.