BATTMAN

Protocol Title

A phase III study of Botensilimab + Balstilimab versus best supportive care in chemo-refractory unresectable colorectal adenocarcinoma: The BATTMAN Trial

Purpose of the Study

Colorectal cancer (CRC) is the 4th most commonly diagnosed cancer in Australia, and the 2nd leading cause of cancer deaths with an estimated 15,000 new cases diagnosed in 2023. Between 20 to 25% of patients presenting with advanced/metastatic disease at initial diagnosis, while a further 20 to 30% of patients initially treated with curative intent subsequently relapse with advanced disease. Survival in patients with advanced CRC remains poor despite currently available treatments – only 15% of patients survive to 5 years.

Immune checkpoint inhibitors (ICI, a type of treatment that stimulates the immune system to fight cancer) have demonstrated good activity against deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) CRC. Unfortunately, dMMR/MSI-H only accounts for 4% of advanced CRC. For the vast majority of patients with proficient mismatch repair/microsatellite stable (pMMR/MSS) advanced CRC, single-agent ICIs have not demonstrated significant benefit.

There is, however, emerging data suggesting that combining ICIs may be able to overcome this resistance in pMMR/MSS CRC. This is an international multi-centre, open-label, randomised phase III trial comparing botensilimab + balstilimab and best supportive care to best supportive care alone in participants with unresectable (metastatic or locally advanced) colorectal adenocarcinoma, which is not mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) and is refractory to available agents, conducted with registrational intent.

DETAILED INFORMATION AVAILABLE

More detailed information available online at ClinicalTrials.gov.

STUDY CHAIRS

Professor Jeanne Tie
Professor Chris Karapetis
Dr John Mak

Funding

Agenus Inc