BMS-986218

Patients receiving anti-CTLA4-NF also exhibited phenotypic signatures of enhanced antitumor T cell priming. In total, this study provides the first-in-human evidence of Treg depletion by glycoengineered antibodies targeting CTLA-4 in humans and their potential in combination with ADT in prostate cancer patients with high-risk of recurrence.

P1, N=26, Active, not recruiting, Columbia University | Trial primary completion date: Jun 2024 --> Jun 2025

P1/2, N=13, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025

P1/2, N=512, Terminated, Bristol-Myers Squibb | N=390 --> 512 | Active, not recruiting --> Terminated; Business Objectives have changed.

P1/2, N=390, Active, not recruiting, Bristol-Myers Squibb | Trial primary completion date: Dec 2023 --> Apr 2024

P2, N=10, Completed, Bristol-Myers Squibb | Recruiting --> Completed | N=204 --> 10

P2, N=204, Recruiting, Bristol-Myers Squibb | Trial completion date: Feb 2026 --> Dec 2023 | Trial primary completion date: Feb 2026 --> Dec 2023

P1/2, N=390, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting

Background: Blockade of the CTLA-4 pathway with ipilimumab (IPI) as monotherapy or in combination with nivolumab (anti–PD-1) is an effective treatment for a variety of cancers. Nonfucosylation of an anti–CTLA-4 antibody increased binding affinity to CD16, induced depletion of Tregs while increasing T-effector cells in mouse tumors, and enhanced tumor growth inhibition in a dose-dependent manner, thus demonstrating improved ADCC compared with IPI. An ongoing phase 1/2 study is evaluating the safety and antitumor activity of anti–CTLA-4 NF alone and in combination with nivolumab (NCT03110107) in patients with advanced solid cancers.