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New treatment option for Renal Cancer
Official title Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
ClinicalTrials.gov ID: NCT05969496
What this study is testing
What is Axitinib?
Axitinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for renal cancer.
Also referred to as Inlyta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Participant self-identified gender ages \>/= 18 years old is acceptable and appropriate if they meet other .
- Histologically proven clear cell component RCC.
- An upfront candidate for definitive surgery per treating Urologist.
You likely can't join if
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior...
- 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...
- 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...
- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy greater than Prednisone 10 mg daily or a steroid equivalent, or any...
See the full eligibility criteria
Who can join
- 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.
- Participant self-identified gender ages \>/= 18 years old is acceptable and appropriate if they meet other .
- 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. Reproductive potential is defined as the following:
- 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...
- 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...
- For males with reproductive potential, use effective birth control during treatment with Axitinib and Pembrolizumab is recommended.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Highlands Ranch, Colorado, United States
- Lone Tree, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Highlands Ranch, Colorado, United States; Lone Tree, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.