Nivolumab + ABI-009 Phase 1/2 Trial for Sarcoma: MTD of 100 mg/m^2

Trial results for Nivolumab (Opdivo®) combined with ABI-009 (nab-rapamycin) in advanced sarcoma and certain cancers were posted on ClinicalTrials.gov on 2025-02-17. The study determined the maximum tolerated dose of ABI-009 to be 100 mg/m^2. Disease control rate, progression-free survival, and overall survival were also measured in 22 participants during the expansion phase.

Background

Nivolumab (Opdivo®) is an established immunotherapy agent. ABI-009 (nab-rapamycin) is a mammalian target of rapamycin (mTOR) inhibitor. This study investigated the safety, toxicity, and potential anti-tumor activity of their sequential administration in patients with advanced cancers, including various sarcomas.

Trial design

This completed Phase 1/2 trial (NCT03190174) enrolled 34 participants to investigate the combination of nivolumab and nab-rapamycin (ABI-009). The study focused on advanced Ewing Sarcoma, PEComa, Epithelioid Sarcoma, Desmoid Tumor, and Chordoma. The trial aimed to assess the safety and initial efficacy signals of this drug combination.

Key results

In the Dose Escalation Phase 1 of the study, the maximum tolerated dose of ABI-009 was determined to be 100 mg/m^2. In the Expansion Phase 1b, the disease control rate, progression-free survival, and overall survival were measured in 22 participants.

What this means

The successful identification of the maximum tolerated dose for ABI-009 in combination with nivolumab provides crucial information for future clinical development of this regimen. The measurements of disease control rate, progression-free survival, and overall survival in the expansion phase offer preliminary insights into the anti-tumor activity of the combination in the specified advanced sarcomas and other cancers. These early-phase results lay the groundwork for further investigation into the efficacy and safety profile of this therapeutic strategy.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03190174, titled "Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers," were posted on 2025-02-17 on clinicaltrials.gov.