TCR2Therapeutics Inc. announced a clinical trial collaboration agreement with Bristol Myers Squibb to evaluate gavo-cel in combination with Opdivo® (nivolumab) and Yervoy® (ipilimumab) in its planned Phase 2 clinical trial in treatment refractory mesothelin-expressing solid tumors. The primary objective of the Phase 2 trial is to evaluate the efficacy of gavo-cel in patients with unresectable, metastatic or recurrent mesothelin-expressing cancers including non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma (MPM) and cholangiocarcinoma. TCR2 is sponsoring the Phase 2 trial.

The planned Phase 2 clinical trial will evaluate the antitumor activity and better characterize the safety of gavo-cel at the selected recommended Phase 2 dose (RP2D). Patients will receive gavo-cel at the RP2D and will be enrolled according to their cancer diagnosis to four distinct cohorts: NSCLC, ovarian cancer, MPM and cholangiocarcinoma. Patients with NSCLC, ovarian cancer, or cholangiocarcinoma will receive the combination of gavo-cel and Opdivo.

Patients with MPM will be treated in three cohorts: the first will administer gavo-cel as a single agent, the second will treat patients with both gavo-cel and Opdivo, and the third will treat patients with gavo-cel, Opdivo and Yervoy.