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Pembrolizumab and Axitinib for Kidney Cancer with IVC Tumor Thrombus

This study is looking at how a combination of two drugs, pembrolizumab and axitinib, affects kidney cancer that has spread into a major blood vessel called the inferior vena cava (IVC). Pembrolizumab is an immunotherapy that helps your body's immune system fight cancer. Axitinib works by blocking certain signals that help cancer grow. The goal is to see if these drugs can shrink the tumor in the IVC before surgery, which might make surgery safer and improve long-term health outcomes. You may be able to join if you are 18 or older and have a specific type of kidney cancer (clear cell component RCC). The study will measure changes in the IVC tumor thrombus (blood clot with cancer cells) size after 12 weeks of treatment. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 17 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive axitinib by mouth twice daily and pembrolizumab intravenously (IV) every 21 days for a total of 12 weeks. You will have scans to check the tumor at 12 weeks and undergo surgery within two weeks after the scans. You will also complete questionnaires about your health during study visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for evaluating tumor changes are measured at baseline and 12 weeks. It is not specified how long participants are followed after this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05969496

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Colorado, Denver
~17 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:AxitinibPembrolizumab

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate Change in IVC Tumor Thrombus Extent Based on the Mayo Classification
Measured over baseline and 12 weeks
+1 more outcome measured

Conditions

Renal Cancer
Kidney Cancer
Renal Cell Carcinoma
Inferior Vena Cava Thrombosis

Explore related trials

Renal Cell Carcinoma

Where it's being run

3 sites across 1 states
Colorado3

Study leadership

  • Elizabeth E Kessler, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Matthew Lee
[email protected]
720-848-0630
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Histologically proven clear cell component RCC.
An upfront candidate for definitive surgery per treating Urologist.
Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per treating urologist.
T Stage of any of the following: cT3b, cT3c, cT4
N stage of any of the following: cN0 or cN1
M stage of any of the following: cM0 or cM1
ECOG performance status 0 - 2.
Urinalysis \<2+ protein. If dipstick is ≥2+ then a 24-hour urine collection should be performed, and the patient may enter the trial if urinary protein is \<2g per 24 hours.
All participants who have reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days prior to starting trial treatment.
Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy
For males with reproductive potential, use effective birth control during treatment with Axitinib and Pembrolizumab is recommended.

Exclusion

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to enrollment.
Has had major surgery within 4 weeks or received radiation therapy within 1 week prior to enrollment to the study.
Has had prior treatment with any anti-programmed cell death (anti-PD-1) or programmed cell death ligand 1 (PD-L1), or an antibody targeting any other immune-regulatory receptors or mechanisms.
Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)/VEGF receptors (VEGFR).
Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema, or anaphylaxis) to Axitinib.
Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy greater than Prednisone 10 mg daily or a steroid equivalent, or any other form of immunosuppressive therapy within 7 days prior to enrollment to the study except in the case of central nervous system (CNS) metastases.
Has an active autoimmune disease requiring systemic treatment within the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjogren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement are not excluded.
Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ, thyroid cancer (papillary, hurthle cell or follicular), or localized prostate cancer are acceptable if they have undergone potentially curative therapy.
Has known active CNS metastases and/or carcinomatous meningitis.
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
ALT or AST above 3 times the upper limit of normal
Has received a live virus vaccine within 30 days of enrollment to the study.
Active GI bleeding, as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation.
Has QT interval corrected for heart rate (QTc) ≥480 msec.
Has a history of any of the following cardiovascular conditions within 12 months of enrollment to the study:
Myocardial infarction
Unstable angina pectoris
Cardiac angioplasty or stenting
Coronary/peripheral artery bypass graft
Class III or IV congestive heart failure per New York Heart Association
Cerebrovascular accident or transient ischemic attack
Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg on 3 or more dose optimized anti- hypertensive medication.
Has evidence of inadequate wound healing per treating physician discretion.
Has active bleeding disorder or other history of significant bleeding episodes within 30 days of enrollment to the study.
Has current use (within 7 days of enrollment) or anticipated need for treatment with drugs or foods that are known to be strong cytochrome P450 (CYP3A4/5) inhibitors.
Has current use (within 7 days of enrollment) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or drugs that are known with proarrhythmic potential.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study by subject self-report.
Has had a prior solid organ transplant.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.

What this trial measures

  • Evaluate Change in IVC Tumor Thrombus Extent Based on the Mayo Classificationbaseline and 12 weeks

    * Patients will get baseline imaging with an MRI of the abdomen to evaluate the level of the IVC TT based on the Mayo Classification. Patients will get an end of treatment MRI at 12 weeks to evaluate the efficacy of neoadjuvant therapy with Pembrolizumab and Axitinib. The Mayo classification is described as below: * Level 0: thrombus limited to the renal vein * Level 1: into IVC \<2cm from renal vein ostium level * Level 2: IVC extension \>2cm from renal vein ostium and below hepatic vein * Level 3: thrombus at the level of or above the hepatic veins but below the diaphragm * Level 4: thrombus extending above the diaphragm

  • Evaluate a change in IVC TT Size from Baselinebaseline and 12 weeks

    o Evaluation of IVC TT anteroposterior and transverse diameter will also be measured at baseline and the end of treatment at 12 weeks. The baseline largest diameter will be subtracted to the largest diameter as the end of treatment divided by the baseline largest diameter will be computed to evaluate the percentage change in the IVC TT size.