Merck IIT: RRP Pembro and Lenvatinib
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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
Eligibility criteria
Qualifiers
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. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the PI.
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.
Disqualifiers
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment.
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.
Trial design
Treatments tested in this trial
- Lenvatinib
- Pembrolizumab
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov