Age
Adult
Eligibility
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the
study.
3. Participant self-identified gender ages >/= 18 years old is acceptable and appropriate if they meet other
inclusion criteria.
4. Histologically proven clear cell component RCC.
5. An upfront candidate for definitive surgery per treating Urologist.
6. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per
treating urologist.
7. cT3b, cT3c, cT4
8. cN0 or cN1
9. cM0 or cM1
10. ECOG performance status 0 – 2.
11. 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.
12. 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:
o 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
hysterectomyIn order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the
study.
3. Participant self-identified gender ages >/= 18 years old is acceptable and appropriate if they meet other
inclusion criteria.
4. Histologically proven clear cell component RCC.
5. An upfront candidate for definitive surgery per treating Urologist.
6. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per
treating urologist.
7. cT3b, cT3c, cT4
8. cN0 or cN1
9. cM0 or cM1
10. ECOG performance status 0 – 2.
11. 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.
12. 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:
o 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