Merck IIT: RRP Pembro and Lenvatinib

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04645602
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Human Papilloma Virus
  • Pulmonary Disease
  • Recurrent Respiratory Papillomatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    Pill taken by mouth, once daily.
  • Pembrolizumab — DRUG
    Intravenous injection through a vein (IV).

Study Details

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

Key Dates

Start date
Jul 18, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib + Pembrolizumab
    Participants will take: Lenvatinib - At a pre-determined dose daily during each 3 week study cycle up to 9 cycles Pembrolizumab - 200 mg infusion on Day 1 of each 3 week study cycle up to 35 cycles Participants will be given a drug diary and asked to document information in the drug diary about the study treatment. Participants will be asked to check their blood pressure 3x every week and document in a supplied diary. Participants will be followed up to one (1) year after study treatment.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: At 12 weeks for up to 2 years and/or end of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Carole Ramm
[email protected]
(203) 785-4095
Sara Pai, MD, Phd (PRINCIPAL_INVESTIGATOR)

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By research site
Yale University· New Haven, CT

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