Sitagliptin With Pembro in RCC and Melanoma
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Sitagliptin
- Pembrolizumab
Treatment groups
64 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Fernando Maciel Barbosa
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov