Sitagliptin With Pembro in RCC and Melanoma

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Fernando Maciel Barbosa
Study ID
NCT07634380
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Melanoma
  • Advanced Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Sitagliptin — DRUG
    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
  • Pembrolizumab — DRUG
    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

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
May 14, 2026
Status verified
Jul 2026
Primary completion
Apr 10, 2028
Completion
Apr 10, 2031

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sitagliptin + Pembrolizumab Combination Therapy (aRCC)
    Participants with refractory or relapsed advanced renal cell carcinoma will receive oral sitagliptin administered daily at escalating dose levels (adjusted by renal function) in combination with fixed-dose pembrolizumab 200 mg IV every 3 weeks. The arm includes a dose-escalation phase to determine the maximum tolerated dose (MTD) of sitagliptin followed by a dose-expansion phase to evaluate preliminary efficacy and safety at the MTD.
  • Experimental: Sitagliptin + Pembrolizumab Combination Therapy (aM)
    Participants with refractory or relapsed advanced melanoma will receive oral sitagliptin administered daily at escalating dose levels (adjusted by renal function) in combination with fixed-dose pembrolizumab 200 mg IV every 3 weeks. This arm similarly includes a dose-escalation phase to determine the MTD of sitagliptin followed by a dose-expansion phase to assess preliminary efficacy and safety at the MTD.

Primary Outcome Measure

Dose-Limiting Toxicities (DLTs) [ Time Frame: During cycle 1 (cycle 1 is 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Fernando M Barbosa, MD
Fernando M Barbosa, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IA

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