Clinical trial · Interventional
A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)
A Clinical Trial to Evaluate the Effect of Neoadjuvant MK-3475 (Pembrolizumab) Therapy on Intratumoral Immune Infiltrates in Renal Cell Cancer (RCC) Patients Undergoing Surgical Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to low enrollment
Summary
Brief summary (as posted)
This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (MK-3475) on tumors of participants with renal cell cancer (RCC). The primary hypotheses are that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic infiltration in at least 30% of participants with RCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab Post-Resection | Drug | — | UNRESOLVED |
| Pembrolizumab Pre-Resection | Drug | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Pembrolizumab + RCC Resection
- description
- Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
- interventionNames
- Drug: Pembrolizumab Pre-Resection
- Procedure: Surgical Resection
- Drug: Pembrolizumab Post-Resection
- type
- EXPERIMENTAL
- label
- RCC Resection
- description
- Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a newly diagnosed RCC, with a primary tumor diameter of more than 4 cm (\>= T1b), not previously treated, and be a candidate for operative tumor resection * Be willing and able to undergo pre-treatment baseline image-guided core biopsy of their primary RCC * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Demonstrate adequate organ function * Female is not breast feeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use two acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment * Male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw. Exclusion Criteria: * Is currently participating in, or has participated in a study with an investigational agent or device within 4 weeks prior to first dose of study therapy * Has a diagnosis of immunosuppression or has received systemic steroid therapy, or any other form of immunosuppressive therapy within 4 weeks prior to first dose of study therapy * Has had prior chemotherapy, targeted small molecule, or radiation therapy for treatment of RCC * Has a known additional (other than RCC) malignancy that is progressing or requires active treatment * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active, or documented history of autoimmune disease, with the exceptions of vitiligo or resolved childhood asthma/atopy * Has a history of (non-infectious) pneumonitis that required treatment with steroids or current pneumonitis. * Has an active infection requiring systematic therapy * Is receiving anticoagulant therapy, with the exception of low dosage aspirin * Has severe cardiovascular disease or symptomatic ischemic heart disease * Has hepatic decompensation * Has uncontrolled thyroid dysfunction * Has uncontrolled diabetes mellitus * Has known psychiatric or substance abuse disorders * Female is pregnant or breastfeeding * Is expecting to conceive children within the projected maximum duration of the trial, extending through 120 days after the last dose of treatment or the last blood draw * Has received prior therapy with any antibody or drug (including ipilimumab) specifically targeting T-cell co-stimulation or checkpoint pathway * Has a known history of human immunodeficiency virus (HIV) * Has known active hepatitis B or C * Has received a live vaccine within 30 days prior to screening
References
Publications (0)
Data not yet available