TrialBridgeNCT07634380
Sitagliptin With Pembro in RCC and Melanoma
Recruiting · Phase 1 · Fernando Maciel Barbosa · registry updated 2026-07-30
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Histologically and/or cytologically confirmed unresectable metastatic renal cell carcinoma with clear cell component with no neuroendocrine differentiation component) or unresectable metastatic melanoma (excluding uveal or mucosal melanoma) that have progressed on treatment with an anti-PD-1/PD-L1 mAb administered either as a monotherapy, or in combination with other immune checkpoint inhibitors or other therapies. Progression on treatment with an anti-PD-1/PD-L1 mAb is defined by meeting all of the following criteria:
- 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
- Measurable disease meeting the following criteria:
Exclusion
- A patient meeting any of the following criteria is not eligible to participate in this study:
- 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
- Participants with diabetes mellitus requiring insulin therapy or sulfonylurea