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Advanced Renal Cell CarcinomaPhase 1NCT07634380

Sitagliptin With Pembro in RCC and Melanoma

A Phase 1 study testing Sitagliptin and Pembrolizumab in people with Advanced Renal Cell Carcinoma and Advanced Melanoma, run by Fernando Maciel Barbosa at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Sitagliptin and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
14 May 2026to 10 Apr 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 28Show fewer
  • 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)
  • 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
  • Aged 18 years and older
  • The participant is capable of understanding and complying with the protocol requirements and has signed the informed consent document
  • Participants must have recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy to < Grade 1 CTCAE unless clinically insignificant and/or stable on supportive therapy.
  • No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Women of childbearing potential (WOCBP) - defined as females who have experienced menarche, have not undergone permanent surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), and are not postmenopausal (no menses for ≥12 consecutive months without an alternative medical cause) - must meet all of the following criteria:
  • Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test must be performed and must be negative prior to enrollment.
  • Agree to use at least one highly effective method of contraception during the study and for a minimum of 4 months after the last dose of pembrolizumab.
  • Acceptable highly effective methods include:
  • Combined (estrogen- and progestogen-containing) hormonal contraception (oral, intravaginal, or transdermal)
  • Progestogen-only hormonal contraception (oral, injectable, or implantable)
  • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomized partner (if confirmed as the sole sexual partner)
  • Complete sexual abstinence (only if this is the participant's usual and preferred lifestyle)
  • Male participants must:
  • Use a condom with spermicide during the study and for at least 4 months after the last dose of pembrolizumab, and
  • Ensure that their female partners of childbearing potential use an additional highly effective method of contraception during this period.
  • Able to swallow pills
  • Adequate archival tissue sample ( 5-10 slides at 5µm) of at least one tumor lesion is mandatory. If archival tissue is not available, Participant must agree to a new biopsy sample.

Who cannot join

  • 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
Show all 21Show fewer
  • Participants taking oral antihyperglycemics (e.g., metformin, DPP-4 inhibitor, SGLT-2 inhibitor) for any cause within 3 months of starting study drug
  • 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
  • Taking digoxin within 6 months of starting study drug
  • Known intolerance or history of severe hypersensitivity reaction (such as anaphylactic shock or angioedema) to sitagliptin or monoclonal antibody
  • Prior anticancer treatment within 28 days (or 5 times the half-life, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study treatment.
  • Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of sitagliptin
  • Active uncontrolled infection requiring systemic therapy.
  • Participant is known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
  • History of organ allograft (participant has had an allogenic tissue/solid organ transplant)
  • Biologic response modifiers (e.g., granulocyte colony-stimulating factor) within 4 weeks before study entry. Chronic erythropoietin therapy is permitted provided that no dose adjustments were made within 2 months before the first dose of study treatment
  • Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical study
  • Females who are pregnant or breastfeeding
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (up to 7.5mg/d of prednisone or equivalent) may be approved after consultation with the sponsor
  • Has history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
  • Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fernando Maciel Barbosa, MD contact

+1 319 467 5611

fernando-macielbarbosa@uiowa.edu

United States1 site, 1 recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Fernando M Barbosa, MD

    Fernando M Barbosa, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1b Study of Sitagliptin in Combination With Pembrolizumab in Refractory or Relapsed Advanced Renal Cell Carcinoma and Melanoma

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SitagliptinDrug

    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

  • PembrolizumabDrug

    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 groups in NCT07634380
Study groupRoleWhat they receive
Sitagliptin + Pembrolizumab Combination Therapy (aRCC)ExperimentalParticipants 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.
Receives: Drug: Sitagliptin; Drug: Pembrolizumab
Sitagliptin + Pembrolizumab Combination Therapy (aM)ExperimentalParticipants 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.
Receives: Drug: Sitagliptin; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicities (DLTs)

    Number of participants experiencing dose-limiting toxicities used to determine the maximum tolerated dose (MTD) of sitagliptin in combination with pembrolizumab.

    Measured: During cycle 1 (cycle 1 is 21 days)

  2. Overall Response Rate (ORR)

    Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as assessed by RECIST v1.1.

    Measured: From treatment initiation up to 60 months or until disease progression or discontinuation, whichever occurs first, assessed every 12 weeks

Secondary outcomes (2)

  1. Disease Control Rate (DCR)

    Proportion of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by RECIST v1.1.

    Measured: From treatment initiation up to 60 months or until disease progression or discontinuation, whichever occurs first, assessed every 12 weeks.

  2. Progression-Free Survival (PFS)

    Time from initiation of study treatment to documented disease progression or death from any cause, whichever occurs first.

    Measured: From treatment initiation until documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start14 May 2026
  3. Primary completion10 Apr 2028 (estimated)
  4. Study completion10 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07634380
Sponsor's protocol ID
202512227
Status last verified
Jul 2026
First submitted
30 Mar 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sitagliptin and Pembrolizumab in people with Advanced Renal Cell Carcinoma and Advanced Melanoma, run by Fernando Maciel Barbosa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fernando Maciel Barbosa, MD (+1 319 467 5611, fernando-macielbarbosa@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicities (DLTs) (time frame: During cycle 1 (cycle 1 is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07634380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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