Sitagliptin With Pembro in RCC and Melanoma
Eligible age
18–99 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Fernando Maciel Barbosa
You may qualify if…
- ✓ 1. 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:
- ✓ 1. Has received at least 2 doses of an approved anti-PD-1/PD-L1 mAb
- ✓ 2. 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
- ✓ 3. 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)
- ✓ 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- ✓ 3. Measurable disease meeting the following criteria:
- ✓ 1. At least 1 lesion of ≥10mm in the longest diameter for a non-lymph node or ≥15mm in the short-axis diameter for a lymph node that is serially measurable according to RECIST v1.1 using computerized tomography/magnetic resonance imaging (CT/MRI)
- ✓ 2. Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show subsequent evidence of substantial size increase to be deemed a target lesion
You may not qualify if…
- ✕ A patient meeting any of the following criteria is not eligible to participate in this study:
- ✕ 1. 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.
- ✕ 2. Participants with renal cell carcinoma with histologic/cytologic component of neuroendocrine differentiation
- ✕ 3. Participants with uveal or mucosal melanoma
- ✕ 4. Participants with both renal cell carcinoma and melanoma
- ✕ 5. Participants with diabetes mellitus requiring insulin therapy or sulfonylurea
- ✕ 6. Participants taking oral antihyperglycemics (e.g., metformin, DPP-4 inhibitor, SGLT-2 inhibitor) for any cause within 3 months of starting study drug
- ✕ 7. Participants with documented history of hypoglycemia requiring medical intervention, oral or intravenous carbohydrate ( glucose, dextrose, fruit juice, or any form of glucagon) or who in the opinion of the investigator are not suitable to receive sitagliptin
Where it's recruiting
Iowa City
Source: ClinicalTrials.gov · NCT07634380 · last updated 2026-07-30