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Sitagliptin With Pembro in RCC and Melanoma

NCT07634380 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-07-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sitagliptin

An 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

DRUG

Pembrolizumab

A 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

Sponsors & Collaborators

  • Fernando Maciel Barbosa

    lead OTHER

Principal Investigators

  • Fernando Maciel Barbosa, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-14
Primary Completion
2028-04-10
Completion
2031-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634380 on ClinicalTrials.gov