Table of Contents
- Trial overview
- Who is being studied
- Treatment groups and randomization
- Study phase and size
- What the trial measures
Trial overview
The available trial for AB521 is a randomized Phase 3 trial in patients with advanced clear cell renal cell carcinoma and metastatic clear cell renal cell carcinoma.[1] The study is authorised and plans to enroll 720 people.[1]
This trial is designed to compare two treatment approaches: casdatifan plus cabozantinib versus placebo plus cabozantinib.[1] The brief summary states that the main purpose is to compare progression-free survival in all randomized patients.[1]
Who is being studied
The trial focuses on people with advanced clear cell renal cell carcinoma or metastatic clear cell renal cell carcinoma.[1] Clear cell renal cell carcinoma is a type of kidney cancer, and metastatic means the cancer has spread to other parts of the body.[1]
The source data does not give a full list of all entry rules, but it shows that the study is meant for patients with these specific cancer types.[1]
Treatment groups and randomization
The study is randomized, which means participants are assigned by chance to a study group.[1] Randomization helps make the groups more balanced and makes the comparison more reliable.[1]
One group receives casdatifan with cabozantinib, and the other group receives placebo with cabozantinib.[1] A placebo is a look-alike treatment that does not contain the active study medicine.[1]
The trial record lists oral cabozantinib and oral placebo in the intervention section, along with casdatifan.[1]
Study phase and size
This is a Phase 3 study.[1] Phase 3 trials are larger studies that compare treatments in many patients to see how well they work.[1]
The planned enrollment is 720 participants.[1] That means the trial aims to include 720 people in total if recruitment is completed as planned.[1]
What the trial measures
The main endpoint is progression-free survival (PFS).[1] PFS is the time from randomization until the cancer gets worse, called progressive disease, or until death from any cause, whichever happens first.[1]
The study uses BICR, which means blinded independent central review, to assess progression according to RECIST 1.1.[1] In simple terms, outside reviewers check scans without knowing which treatment the patient received, and RECIST 1.1 is a standard way to measure tumor change on scans.[1]
The brief summary says the trial is comparing PFS between the casdatifan plus cabozantinib group and the placebo plus cabozantinib group in all randomized patients.[1]
