Is NCT05969496 recruiting in Lone Tree, CO?

Yes, NCT05969496 is currently recruiting participants at its Lone Tree, CO location. This kidney cancer clinical trial is actively enrolling qualified participants.

How do I join the kidney cancer clinical trial in Lone Tree?

To join this clinical trial in Lone Tree, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Lone Tree clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Kidney Cancer Clinical Trial in Lone Tree, CO

About This Kidney Cancer Study in Lone Tree

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.

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

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 inclusion criteria.

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 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 Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lone Tree?

Yes, this clinical trial (NCT05969496) has an active research site in Lone Tree, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Kidney Cancer Treatment Options in Lone Tree, CO

If you're searching for kidney cancer treatment options in Lone Tree, CO, this clinical trial (NCT05969496) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lone Tree research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced kidney cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all kidney cancer clinical trials near you to find additional studies recruiting in your area.

Kidney Cancer Clinical Trial in Lone Tree, CO

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