Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer

Summary

The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.

Timeline

Start

2016-10-12

Primary completion

2018-10-18

Completion

2022-06-07

Outcome

Missed primary endpoint

registry p = 0.07; Hazard Ratio (HR) 0.72 (90% CI 0.54 to 0.97); Log Rank NCT02870920 ↗

paper the median OS was 6.6 months for durvalumab and tremelimumab and 4.1 months for BSC (hazard ratio [HR], 0.72; 90% CI, 0.54-0.97; P = .07). PMID 32379280 ↗

Publications

• Results Chen EX, Jonker DJ, Loree JM, Kennecke HF, Berry SR, Couture F, Ahmad CE, Goffin JR, Kavan P, Harb M, Colwell B, Samimi S, Samson B, Abbas T, Aucoin N, Aubin F, Koski SL, Wei AC, Magoski NM, Tu D, O'Callaghan CJ. Effect of Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone in Patients With Advanced Colorectal Cancer: The Canadian Cancer Trials Group CO.26 Study. JAMA Oncol. 2020 Jun 1;6(6):831-838. doi: 10.1001/jamaoncol.2020.0910.
• Results Eric X. Chen, MD, PhD; Jonathan M. Loree, MD; Emma Titmuss, MSc; Derek J. Jonker, MD; Hagen F. Kennecke, MD; Scott Berry, MD; Felix Couture, MD; Chaudharry E. Ahmad, MD; John R. Goffin, MD; Petr Kavan, MD; Mohammed Harb, MD; Bruce Colwell, MD; Setareh Samimi, MD; Benoit Samson, MD; Tahir Abbas,MD; Nathalie Aucoin, MD; Francine Aubin, MD; Sheryl Koski, MD; Alice C.Wei, MD; Dongsheng Tu, PhD; Chris J. O'Callaghan, PhD
• Ma LX, Titmuss E, Loree JM, Jonker DJ, Kennecke HF, Berry S, Couture F, Ahmad CE, Goffin JR, Kavan P, Harb M, Colwell B, Samimi S, Samson B, Abbas T, Aucoin N, Aubin F, Koski S, Tu D, O'Callaghan C, Chen EX. Plasma arginine as a predictive biomarker for outcomes with immune checkpoint inhibition in metastatic colorectal cancer: a correlative analysis of the CCTG CO.26 trial. J Immunother Cancer. 2024 Dec 4;12(12):e010094. doi: 10.1136/jitc-2024-010094.
• Wu FTH, Topham JT, O'Callaghan CJ, Feilotter H, Kennecke HF, Drusbosky L, Renouf DJ, Jonker DJ, Tu D, Chen EX, Loree JM. Kinetic Profiling of RAS Mutations With Circulating Tumor DNA in the Canadian Cancer Trials Group CO.26 Trial Suggests the Loss of RAS Mutations in Neo-RAS-Wildtype Metastatic Colorectal Cancer Is Transient. JCO Precis Oncol. 2024 Aug;8:e2400031. doi: 10.1200/PO.24.00031.
• Topham JT, O'Callaghan CJ, Feilotter H, Kennecke HF, Lee YS, Li W, Banks KC, Quinn K, Renouf DJ, Jonker DJ, Tu D, Chen EX, Loree JM. Circulating Tumor DNA Identifies Diverse Landscape of Acquired Resistance to Anti-Epidermal Growth Factor Receptor Therapy in Metastatic Colorectal Cancer. J Clin Oncol. 2023 Jan 20;41(3):485-496. doi: 10.1200/JCO.22.00364. Epub 2022 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	75 mg	Intravenous

Indications