Sitagliptin With Pembro in RCC and Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorFernando Maciel Barbosa
About this trial
This study is testing whether adding the drug sitagliptin to the standard immunotherapy pembrolizumab is safe and may help people with advanced melanoma or advanced renal cell carcinoma (kidney cancer) whose cancer has stopped responding to prior PD-1 or PD-L1 immunotherapy.
The study has two parts. In the first part, small groups of participants will receive different doses of sitagliptin along with a fixed dose of pembrolizumab. This helps researchers find the highest dose of sitagliptin that can be given safely. In the second part, more participants will receive the safest dose to see how well the drug combination works against their cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has received at least 2 doses of an approved anti-PD-1/PD-L1 mAb
Has demonstrated disease progression after anti-PD-1/PD-L1 mAb as defined by RECIST v1.1. The initial evidence of disease progression (PD) is confirmed by a second assessment no less than 4 weeks from the date of the first documented PD
Progressive disease has been documented within 12 weeks from last dose of anti-PD-1/PD-L1 mAb (refractory disease) or ≥12 weeks from last dose of anti-PD-1/PD-L1 mAb (late relapse)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Disqualifiers
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Participants with renal cell carcinoma with histologic/cytologic component of neuroendocrine differentiation
Participants with uveal or mucosal melanoma
Participants with both renal cell carcinoma and melanoma
Trial design
Design model
Parallel
Treatments tested in this trial
Sitagliptin
DrugAn oral dipeptidyl peptidase-4 (DPP-4) inhibitor administered once daily at escalating dose levels adjusted for renal function, used to evaluate safety and potential immunomodulatory and anti-tumor activity in combination with pembrolizumab
Pembrolizumab
DrugA programmed death-1 (PD-1) immune checkpoint inhibitor administered as a 200 mg intravenous infusion every 3 weeks, used as standard-of-care immunotherapy in advanced melanoma and renal cell carcinoma
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Sitagliptin + Pembrolizumab Combination Therapy (aRCC)Experimental treatment 2 interventions
Group B: Sitagliptin + Pembrolizumab Combination Therapy (aM)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dose-Limiting Toxicities (DLTs)
Number of participants experiencing dose-limiting toxicities used to determine the maximum tolerated dose (MTD) of sitagliptin in combination with pembrolizumab.
Time frame
During cycle 1 (cycle 1 is 21 days)2
Overall Response Rate (ORR)
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as assessed by RECIST v1.1.
Time frame
From treatment initiation up to 60 months or until disease progression or discontinuation, whichever occurs first, assessed every 12 weeksSecondary outcomes
1
Disease Control Rate (DCR)
Proportion of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by RECIST v1.1.
Time frame
From treatment initiation up to 60 months or until disease progression or discontinuation, whichever occurs first, assessed every 12 weeks.2
Progression-Free Survival (PFS)
Time from initiation of study treatment to documented disease progression or death from any cause, whichever occurs first.
Time frame
From treatment initiation until documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fernando Maciel Barbosa
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov