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

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ClinicalTrials.gov Identifier: NCT02870920
Recruitment Status : Completed
First Posted : August 17, 2016
Results First Posted : January 19, 2021
Last Update Posted : December 8, 2023
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Tremelimumab
Drug: Durvalumab
Other: Best Supportive Care
Enrollment 180
Recruitment Details From August 10, 2016 to June 29, 2017 in 27 cancer centres in Canada
Pre-assignment Details  
Arm/Group Title Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Hide Arm/Group Description

Best supportive care available

Best Supportive Care

Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care

Tremelimumab

Durvalumab

Best Supportive Care
Period Title: Overall Study
Started 61 119
Completed 61 119
Not Completed 0 0
Arm/Group Title Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care Total
Hide Arm/Group Description

Best supportive care available

Best Supportive Care

Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care

Tremelimumab

Durvalumab

Best Supportive Care

 Total of all reporting groups
Overall Number of Baseline Participants 61 119 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 119 participants 180 participants
Younger than 65 years
31
  50.8%
56
  47.1%
87
  48.3%
65 years or older
30
  49.2%
63
  52.9%
93
  51.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 119 participants 180 participants
Female
14
  23.0%
45
  37.8%
59
  32.8%
Male
47
  77.0%
74
  62.2%
121
  67.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 119 participants 180 participants
American Indian or Alaska Native
1
   1.6%
2
   1.7%
3
   1.7%
Asian
3
   4.9%
16
  13.4%
19
  10.6%
Native Hawaiian or Other Pacific Islander
1
   1.6%
0
   0.0%
1
   0.6%
Black or African American
2
   3.3%
3
   2.5%
5
   2.8%
White
54
  88.5%
97
  81.5%
151
  83.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.8%
1
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 61 participants 119 participants 180 participants
61 119 180
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 119 participants 180 participants
0
17
  27.9%
33
  27.7%
50
  27.8%
1
44
  72.1%
86
  72.3%
130
  72.2%
[1]
Measure Description:

0: Fully active, able to carry on all pre-disease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. Dead
1.Primary Outcome
Title Overall Survival
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Hide Arm/Group Description:

Best supportive care available

Best Supportive Care

Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care

Tremelimumab

Durvalumab

Best Supportive Care
Overall Number of Participants Analyzed 61 119
Median (90% Confidence Interval)
Unit of Measure: months
4.1
(3.3 to 6.0)
6.6
(6.0 to 7.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Best Supportive Care, Durvalumab Plus Tremelimumab and Best Supportive Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 90%
0.54 to 0.97
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival
Hide Description Defined as the time from randomization to the first objective documentation of disease progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death due to any cause with patients who had not progressed or died at the time of final analysis censored on the date of the last tumour assessment.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Hide Arm/Group Description:

Best supportive care available

Best Supportive Care

Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care

Tremelimumab

Durvalumab

Best Supportive Care
Overall Number of Participants Analyzed 61 119
Median (90% Confidence Interval)
Unit of Measure: Months
1.9
(1.8 to 1.9)
1.8
(1.8 to 1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Best Supportive Care, Durvalumab Plus Tremelimumab and Best Supportive Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.76 to 1.34
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate
Hide Description Defined as percentage of participants with objective response over all participants randomized. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Hide Arm/Group Description:

Best supportive care available

Best Supportive Care

Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care

Tremelimumab

Durvalumab

Best Supportive Care
Overall Number of Participants Analyzed 61 119
Measure Type: Count of Participants
Unit of Measure: Participants
Responded
0
   0.0%
1
   0.8%
Not responded
61
 100.0%
118
  99.2%
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Hide Arm/Group Description

Best supportive care available

Best Supportive Care

Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care

Tremelimumab

Durvalumab

Best Supportive Care
All-Cause Mortality
Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Affected / at Risk (%) Affected / at Risk (%)
Total   54/61 (88.52%)   100/118 (84.75%) 
Hide Serious Adverse Events
Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   55/118 (46.61%) 
Blood and lymphatic system disorders     
Anemia † 1  0/61 (0.00%)  2/118 (1.69%) 
Endocrine disorders     
Adrenal insufficiency † 1  0/61 (0.00%)  2/118 (1.69%) 
Hyperthyroidism † 1  0/61 (0.00%)  1/118 (0.85%) 
Gastrointestinal disorders     
Abdominal distension † 1  0/61 (0.00%)  1/118 (0.85%) 
Abdominal pain † 1  0/61 (0.00%)  3/118 (2.54%) 
Colitis † 1  0/61 (0.00%)  2/118 (1.69%) 
Colonic obstruction † 1  0/61 (0.00%)  2/118 (1.69%) 
Diarrhea † 1  0/61 (0.00%)  3/118 (2.54%) 
Hemorrhoidal hemorrhage † 1  0/61 (0.00%)  1/118 (0.85%) 
Small intestinal obstruction † 1  0/61 (0.00%)  4/118 (3.39%) 
Upper gastrointestinal hemorrhage † 1  0/61 (0.00%)  1/118 (0.85%) 
Other gastrointestinal disorders † 1  0/61 (0.00%)  1/118 (0.85%) 
General disorders     
Death NOS † 1  0/61 (0.00%)  3/118 (2.54%) 
Fatigue † 1  0/61 (0.00%)  2/118 (1.69%) 
Fever † 1  0/61 (0.00%)  4/118 (3.39%) 
Flu like symptoms † 1  0/61 (0.00%)  1/118 (0.85%) 
Other general disorders, administration site conditions † 1  0/61 (0.00%)  1/118 (0.85%) 
Immune system disorders     
Other immune system disorders † 1  0/61 (0.00%)  1/118 (0.85%) 
Infections and infestations     
Biliary tract infection † 1  0/61 (0.00%)  1/118 (0.85%) 
Catheter related infection † 1  0/61 (0.00%)  1/118 (0.85%) 
Kidney infection † 1  0/61 (0.00%)  1/118 (0.85%) 
Lung infection † 1  0/61 (0.00%)  4/118 (3.39%) 
Sepsis † 1  0/61 (0.00%)  5/118 (4.24%) 
Urinary tract infection † 1  0/61 (0.00%)  2/118 (1.69%) 
Other infections and infestations † 1  0/61 (0.00%)  2/118 (1.69%) 
Injury, poisoning and procedural complications     
Fall † 1  0/61 (0.00%)  1/118 (0.85%) 
Intestinal stoma obstruction † 1  0/61 (0.00%)  1/118 (0.85%) 
Investigations     
Blood bilirubin increased † 1  0/61 (0.00%)  3/118 (2.54%) 
Cardiac troponin T increased † 1  0/61 (0.00%)  1/118 (0.85%) 
Creatinine increased † 1  0/61 (0.00%)  2/118 (1.69%) 
Lipase increased † 1  0/61 (0.00%)  1/118 (0.85%) 
Metabolism and nutrition disorders     
Anorexia † 1  0/61 (0.00%)  1/118 (0.85%) 
Hyperglycemia † 1  0/61 (0.00%)  2/118 (1.69%) 
Hyperkalemia † 1  0/61 (0.00%)  1/118 (0.85%) 
Hypoglycemia † 1  0/61 (0.00%)  1/118 (0.85%) 
Musculoskeletal and connective tissue disorders     
Arthritis † 1  0/61 (0.00%)  1/118 (0.85%) 
Flank pain † 1  0/61 (0.00%)  1/118 (0.85%) 
Generalized muscle weakness † 1  0/61 (0.00%)  2/118 (1.69%) 
Muscle weakness left-sided † 1  0/61 (0.00%)  1/118 (0.85%) 
Muscle weakness lower limb † 1  0/61 (0.00%)  1/118 (0.85%) 
Muscle weakness upper limb † 1  0/61 (0.00%)  1/118 (0.85%) 
Pain in extremity † 1  0/61 (0.00%)  2/118 (1.69%) 
Nervous system disorders     
Edema cerebral † 1  0/61 (0.00%)  1/118 (0.85%) 
Intracranial hemorrhage † 1  0/61 (0.00%)  1/118 (0.85%) 
Psychiatric disorders     
Confusion † 1  0/61 (0.00%)  1/118 (0.85%) 
Renal and urinary disorders     
Acute kidney injury † 1  0/61 (0.00%)  1/118 (0.85%) 
Hematuria † 1  0/61 (0.00%)  1/118 (0.85%) 
Urinary incontinence † 1  0/61 (0.00%)  1/118 (0.85%) 
Reproductive system and breast disorders     
Pelvic pain † 1  0/61 (0.00%)  1/118 (0.85%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea † 1  0/61 (0.00%)  2/118 (1.69%) 
Pleural effusion † 1  0/61 (0.00%)  1/118 (0.85%) 
Pneumonitis † 1  0/61 (0.00%)  2/118 (1.69%) 
Other respiratory, thoracic and mediastinal disorders † 1  /61  1/118 (0.85%) 
Vascular disorders     
Hypotension † 1  0/61 (0.00%)  1/118 (0.85%) 
Thromboembolic event † 1  0/61 (0.00%)  1/118 (0.85%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Best Supportive Care Durvalumab Plus Tremelimumab and Best Supportive Care
Affected / at Risk (%) Affected / at Risk (%)
Total   51/61 (83.61%)   116/118 (98.31%) 
Endocrine disorders     
Hypothyroidism † 1  1/61 (1.64%)  10/118 (8.47%) 
Gastrointestinal disorders     
Abdominal distension † 1  2/61 (3.28%)  6/118 (5.08%) 
Abdominal pain † 1  18/61 (29.51%)  53/118 (44.92%) 
Constipation † 1  14/61 (22.95%)  49/118 (41.53%) 
Diarrhea † 1  6/61 (9.84%)  37/118 (31.36%) 
Dry mouth † 1  2/61 (3.28%)  11/118 (9.32%) 
Dyspepsia † 1  7/61 (11.48%)  17/118 (14.41%) 
Gastroesophageal reflux disease † 1  5/61 (8.20%)  5/118 (4.24%) 
Nausea † 1  17/61 (27.87%)  53/118 (44.92%) 
Vomiting † 1  9/61 (14.75%)  30/118 (25.42%) 
Other gastrointestinal disorders † 1  2/61 (3.28%)  10/118 (8.47%) 
General disorders     
Chills † 1  1/61 (1.64%)  10/118 (8.47%) 
Edema limbs † 1  12/61 (19.67%)  14/118 (11.86%) 
Fatigue † 1  34/61 (55.74%)  91/118 (77.12%) 
Fever † 1  6/61 (9.84%)  15/118 (12.71%) 
Flu like symptoms † 1  1/61 (1.64%)  9/118 (7.63%) 
Non-cardiac chest pain † 1  1/61 (1.64%)  6/118 (5.08%) 
Pain † 1  9/61 (14.75%)  27/118 (22.88%) 
Infections and infestations     
Urinary tract infection † 1  0/61 (0.00%)  14/118 (11.86%) 
Investigations     
Weight loss † 1  1/61 (1.64%)  23/118 (19.49%) 
Metabolism and nutrition disorders     
Anorexia † 1  22/61 (36.07%)  60/118 (50.85%) 
Dehydration † 1  1/61 (1.64%)  8/118 (6.78%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  12/61 (19.67%)  25/118 (21.19%) 
Bone pain † 1  0/61 (0.00%)  10/118 (8.47%) 
Chest wall pain † 1  0/61 (0.00%)  7/118 (5.93%) 
Flank pain † 1  0/61 (0.00%)  7/118 (5.93%) 
Generalized muscle weakness † 1  1/61 (1.64%)  8/118 (6.78%) 
Muscle weakness lower limb † 1  3/61 (4.92%)  7/118 (5.93%) 
Myalgia † 1  1/61 (1.64%)  7/118 (5.93%) 
Pain in extremity † 1  4/61 (6.56%)  21/118 (17.80%) 
Other musculoskeletal and connective tissue disorder † 1  2/61 (3.28%)  6/118 (5.08%) 
Nervous system disorders     
Dizziness † 1  1/61 (1.64%)  6/118 (5.08%) 
Dysgeusia † 1  3/61 (4.92%)  8/118 (6.78%) 
Headache † 1  4/61 (6.56%)  15/118 (12.71%) 
Paresthesia † 1  2/61 (3.28%)  11/118 (9.32%) 
Peripheral sensory neuropathy † 1  18/61 (29.51%)  40/118 (33.90%) 
Psychiatric disorders     
Anxiety † 1  7/61 (11.48%)  13/118 (11.02%) 
Confusion † 1  3/61 (4.92%)  6/118 (5.08%) 
Insomnia † 1  11/61 (18.03%)  43/118 (36.44%) 
Renal and urinary disorders     
Hematuria † 1  2/61 (3.28%)  6/118 (5.08%) 
Urinary frequency † 1  2/61 (3.28%)  6/118 (5.08%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  10/61 (16.39%)  41/118 (34.75%) 
Dyspnea † 1  18/61 (29.51%)  45/118 (38.14%) 
Other respiratory, thoracic and mediastinal disorders † 1  1/61 (1.64%)  8/118 (6.78%) 
Skin and subcutaneous tissue disorders     
Dry skin † 1  2/61 (3.28%)  12/118 (10.17%) 
Pruritus † 1  0/61 (0.00%)  23/118 (19.49%) 
Rash acneiform † 1  3/61 (4.92%)  11/118 (9.32%) 
Rash maculo-papular † 1  5/61 (8.20%)  28/118 (23.73%) 
Other skin and subcutaneous tissue disorders † 1  1/61 (1.64%)  6/118 (5.08%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chris O'Callaghan
Organization: Canadian Cancer Trials Group
Phone: 6135336430
EMail: cocallaghan@ctg.queensu.ca
Publications of 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.
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
Layout table for additonal information
Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT02870920    
Other Study ID Numbers: CO26
First Submitted: August 10, 2016
First Posted: August 17, 2016
Results First Submitted: November 20, 2020
Results First Posted: January 19, 2021
Last Update Posted: December 8, 2023