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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lenvatinib
DrugPill taken by mouth, once daily.
Pembrolizumab
DrugIntravenous injection through a vein (IV).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Lenvatinib + PembrolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
To evaluate the best objective response rate (ORR: CR/PR) in subjects with RRP with measurable or evaluable pulmonary involvement based on RECIST 1.1 and the endoscopic lesional burden score
Time frame
At 12 weeks for up to 2 years and/or end of treatment2
Adverse Events
To evaluate the safety and tolerability of the combination of pembrolizumab and lenvatinib in subjects with RRP as measured by the number of participants experiencing adverse events
Time frame
Every 3 weeks for up to 2 years and/or end of treatmentSecondary outcomes
1
Objective Response Rate
To evaluate the best ORR in subjects with RRP with extensive laryngeal and tracheal involvement based on endoscopic lesional (EL) burden score
Time frame
Baseline to a post-baseline timepoint up to 2 years and/or end of treatment2
Change in Time Interval
To measure the change in time interval, as measured in weeks, between surgical or procedural interventions with the combination of pembrolizumab and lenvatinib treatment
Time frame
Baseline to a post-baseline timepoint up to 2 years and/or end of treatment3
Duration of Response
To evaluate the duration of response (DOR) in subjects receiving the combination of pembrolizumab and lenvatinib. DOR will be summarized using Kaplan-Meier method with a corresponding 95% Confidence Interval (CI).
Time frame
Baseline to a post-baseline timepoint up to 2 years and/or end of treatmentSponsors and contacts
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Source ClinicalTrials.gov