Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients With Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies
1 other identifier
interventional
180
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Oct 2016
Longer than P75 for phase_2 colorectal-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedStudy Start
First participant enrolled
October 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2018
CompletedResults Posted
Study results publicly available
January 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2022
CompletedDecember 8, 2023
June 1, 2022
2 years
August 10, 2016
November 20, 2020
December 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Time from randomization to death from any cause with patients who were alive at the time of the final analysis or who became lost to follow-up censored at their last date known to be alive.
24 months
Secondary Outcomes (2)
Progression-free Survival
24 months
Objective Response Rate
24 months
Study Arms (2)
Best Supportive Care
ACTIVE COMPARATORBest supportive care available
Durvalumab plus Tremelimumab and Best Supportive Care
EXPERIMENTALTremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care
Interventions
Eligibility Criteria
You may qualify if:
- Must have histologically or pathologically confirmed advanced (metastatic or locally advanced) colorectal cancer that is unresectable.
- Received a prior thymidylate synthase inhibitor (e.g. 5-fluorouracil (5-FU), capecitabine, raltitrexed, UFT) for metastatic disease or as adjuvant therapy. A thymidylate synthase inhibitor may have been given in combination with oxaliplatin or irinotecan.
- Received and failed an irinotecan -containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease, OR relapsed within 6 months of completion of an irinotecan-containing adjuvant therapy, OR have documented unsuitability for an irinotecan-containing regimen.
- Received and failed an oxaliplatin-containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease, OR relapsed within 6 months of completion of an oxaliplatin-containing adjuvant therapy OR have documented unsuitability for an oxaliplatin-containing regimen.
- For patients with colorectal cancer that is RAS-wild type:
- Received and failed a cetuximab or panitumumab-containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease OR have documented unsuitability for a cetuximab or panitumumab-containing regimen
- Patient prior treatment with VEGF targeting therapy, such as bevacizumab, aflibercept, ramucirumab, or regorafenib, is permitted but not mandatory. Reasons not used are to be documented.
- Patient prior treatment with TAS-102 (an agent composed of a combination of trifluorothymidine (FTD) and tipiracil hydrochloride (TPI)), is permitted but not mandatory.
- The only remaining standard available therapy as recommended by the Investigator, in consultation with the patient, is best supportive care.
- Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
- Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease done within 28 days prior to randomization.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 12 weeks at the time of study entry.
- Must be ≥ 18 years of age.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Cancer Trials Grouplead
- AstraZenecacollaborator
Study Sites (25)
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9, Canada
London Regional Cancer Program
London, Ontario, N6A 5W9, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Hopital de la Cite-de-la-Sante
Laval, Quebec, H7M 3L9, Canada
L'Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
The Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre Integre Universitaire De Sante Et De Services
Montreal, Quebec, H4J 1C5, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Centre hospitalier regional de Trois-Rivieres
Trois-Rivières, Quebec, G8Z 3R9, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (4)
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.
PMID: 32379280RESULTEric 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
RESULTMa 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.
PMID: 39631846DERIVEDTopham 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.
PMID: 36007218DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chris O'Callaghan
- Organization
- Canadian Cancer Trials Group
Study Officials
- STUDY CHAIR
Eric Chen
Univ. Health Network-Princess Margaret Hospital, Toronto ON Canada
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 17, 2016
Study Start
October 12, 2016
Primary Completion
October 18, 2018
Study Completion
June 7, 2022
Last Updated
December 8, 2023
Results First Posted
January 19, 2021
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share