Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Ren… (NCT05188118) | Clinical Trial Compass
CompletedEarly Phase 1
Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
United States10 participantsStarted 2023-02-15
Plain-language summary
This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hgb ≥ 9.0g/dL
. White blood count ≥ 2500/ µL
. ANC ≥1 x 109/L (≥1500/L) without growth factor support
. Plt count ≥ 100 x 109 /L (≥100,000/L) without transfusion
. Total serum bilirubin ≤1.5 x institutional ULN; Gilbert's disease, Total serum bilirubin ≤3 x institutional ULN
. Serum transaminases (AST/ALT) ≤3 x the institutional ULN; ALP ≤5 x the institutional ULN with documented bone metastasis
. Serum albumin ≥ 2.8 g/dl
. PT/INR or PTT test ≥ 1.3 x the laboratory ULN
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins.
. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
. Cardiovascular disorders:
. GI disorders including those associated with a high risk of perforation or fistula formation:
. Serious non-healing wound/ulcer/bone fracture.
. Uncompensated/symptomatic hypothyroidism.
. Moderate to severe hepatic impairment (Child-Pugh B or C).