Pixatimod (PG545) Plus Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and With Nivolumab and Low-dose Cyclophosphamide in MSS Metastatic Colorectal Carcinoma (mCRC)

Phase 2 Completed 13 enrolled Diwakar Davar Aculeus Therapeutics · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary goal of this trial is to assess clinical response to nivolumab and pixatimod, and, nivolumab, pixatimod and cyclophosphamide in three separate patient cohorts. Cohort 1: MSS mCRC in combination with low-dose cyclophosphamide, Cohort 2: PD-1 relapsed/refractory melanoma, and Cohort 3: PD-1 relapsed/refractory NSCLC.

Timeline

Start: 2021-12-09
Primary completion: 2024-02-05
Completion: 2024-03-18

Outcome

Missed primary endpoint

registry analysis (superiority test); Pixatimod (PG545) + Nivolumab - Cohort 1 vs Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 2 & Cohort 3; p = 1.0000; Fisher Exact NCT05061017 ↗

Publications

Lemech C, Dredge K, Bampton D, Hammond E, Clouston A, Waterhouse NJ, Stanley AC, Leveque-El Mouttie L, Chojnowski GM, Haydon A, Pavlakis N, Burge M, Brown MP, Goldstein D. Phase Ib open-label, multicenter study of pixatimod, an activator of TLR9, in combination with nivolumab in subjects with microsatellite-stable metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma and other solid tumors. J Immunother Cancer. 2023 Jan;11(1):e006136. doi: 10.1136/jitc-2022-006136.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	50 mg	Oral
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Subject	Pixatimod	Unknown	25 mg	Intravenous