Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGiuseppe Procopio
About this trial
This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.
Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.
Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.
The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic or advanced Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma will be enrolled in this study.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Have confirmed histology diagnosis of Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma by central pathology review.
Disqualifiers
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Has received prior systemic anti-cancer therapy, including investigational agents, within 2 weeks prior to treatment allocation.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS diseases permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab + Enfortumab Vedotin
Drug* Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression. * Enfortumab Vedotin will be given for a maximum of 3 cycles on day 1 and day 3 each 3 weeks. EV treatment could be re-started in case of Progressive Disease RECIST v1.1 during pembrolizumab monotherapy treatment.
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab + Enfortumab VedotinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR in patients treated with Pembrolizumab plus Enfortumab Vedotin
The proportion of patients who have a partial or complete response to Pembrolizumab + Enfortumab Vedotin
Time frame
24 MonthsSecondary outcomes
1
Progression-free survival (PFS) in patients treated with Pembrolizumab plus Enfortumab Vedotin
The time from assignment to Pembrolizumab plus Enfortumab Vedotin to disease progression or death from any cause
Time frame
24 Months2
Overall-survival (OS) in patients treated with Pembrolizumab plus Enfortumab Vedotin
Survival from assignment to Pembrolizumab plus Enfortumab Vedotin to time of death.
Time frame
48 Months3
Number of Participants treated with Pembrolizumab + Enfortumab Vedotin who experience AEs/SAEs
The incidence of, causality, and outcome of AEs/SAEs. AEs will be assessed as defined by CTCAE, Version \[5.0\].
Time frame
24 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Giuseppe Procopio
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor institution
Source ClinicalTrials.gov