Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thro… (NCT05969496) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
United States17 participantsStarted 2023-12-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 fol…
What they're measuring
1
Evaluate Change in IVC Tumor Thrombus Extent Based on the Mayo Classification