Update on Clinical Trials At UT MD Anderson by Dr. Pavlos Msaouel
- December 12, 2024
Weblinks:
MD Anderson webpage for the trial: https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-1062.html
NIH webpage for the trial: https://clinicaltrials.gov/study/NCT06444880
NCI webpage for the trial: https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-04755
Description:
This new clinical trial is testing a new treatment called ubamatamab for two rare and aggressive cancers: renal medullary carcinoma and epithelioid sarcoma. Both cancers lack a key protein named SMARCB1 and can often produce high levels of another protein called MUC16, also known as CA-125. Ubamatamab is an antibody designed to both target MUC16 on cancer cells and redirect the immune system’s T cells to attack the tumor, even when other immune therapies fail.
The trial will involve up to 40 patients with renal medullary carcinoma and epithelioid sarcoma who have already tried other treatments and whose tumors express high levels of MUC16, which is the target of ubamatamab. We will first determine whether the cancer express enough MUC16 by checking CA-125 levels in the serum. If the CA-125 levels in the serum are high enough then this will tell us that the target of ubamatamab is expressed on enough cancer cells for the patient to be eligible for the trial. If serum CA-125 levels are low, then we will check if the cancer tissue (obtained via a recent biopsy within 12 months) expresses enough MUC16 levels for ubamatamab to potentially target. If MUC16 is adequately expressed on the cancer cells then the patient will be eligible for the trial even if CA-125 levels are low in the serum.
In the first stage, patients enrolled in the trial will receive ubamatamab alone, and those whose cancer progresses may move to the second stage, where ubamatamab will be combined with another immune therapy, cemiplimab. Cemiplimab helps the immune system fight cancer by blocking a protein called PD-1, which some cancer cells use to hide from immune cells. This allows the immune cells to recognize and attack the cancer.
The goal of the trial is to measure how many patients respond to treatment and how long their cancer stays under control, while also studying the safety and effects of the therapy on the immune system. Early results from a patient with epithelioid sarcoma showed promising outcomes, and this trial will explore if ubamatamab can offer hope to more patients with these challenging cancers.