Trial Outcomes & Findings for Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer (NCT NCT02870920)
NCT ID: NCT02870920
Last Updated: 2023-12-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
24 months
Results posted on
2023-12-08
Participant Flow
From August 10, 2016 to June 29, 2017 in 27 cancer centres in Canada
Participant milestones
| Measure |
Best Supportive Care
Best supportive care available
Best Supportive Care
|
Durvalumab Plus Tremelimumab and 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 Study
STARTED
|
61
|
119
|
|
Overall Study
COMPLETED
|
61
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Best Supportive Care
n=61 Participants
Best supportive care available
Best Supportive Care
|
Durvalumab Plus Tremelimumab and Best Supportive Care
n=119 Participants
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
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Younger than 65 years
|
31 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Customized
65 years or older
|
30 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
61 participants
n=5 Participants
|
119 participants
n=7 Participants
|
180 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
17 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
44 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All randomized patients.
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.
Outcome measures
| Measure |
Best Supportive Care
n=61 Participants
Best supportive care available
Best Supportive Care
|
Durvalumab Plus Tremelimumab and Best Supportive Care
n=119 Participants
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 Survival
|
4.1 months
Interval 3.3 to 6.0
|
6.6 months
Interval 6.0 to 7.4
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All randomized patients
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.
Outcome measures
| Measure |
Best Supportive Care
n=61 Participants
Best supportive care available
Best Supportive Care
|
Durvalumab Plus Tremelimumab and Best Supportive Care
n=119 Participants
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
|
|---|---|---|
|
Progression-free Survival
|
1.9 Months
Interval 1.8 to 1.9
|
1.8 Months
Interval 1.8 to 1.9
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All randomized patients
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.
Outcome measures
| Measure |
Best Supportive Care
n=61 Participants
Best supportive care available
Best Supportive Care
|
Durvalumab Plus Tremelimumab and Best Supportive Care
n=119 Participants
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
|
|---|---|---|
|
Objective Response Rate
Responded
|
0 Participants
|
1 Participants
|
|
Objective Response Rate
Not responded
|
61 Participants
|
118 Participants
|
Adverse Events
Best Supportive Care
Serious events: 0 serious events
Other events: 51 other events
Deaths: 54 deaths
Durvalumab Plus Tremelimumab and Best Supportive Care
Serious events: 55 serious events
Other events: 116 other events
Deaths: 100 deaths
Serious adverse events
| Measure |
Best Supportive Care
n=61 participants at risk
Best supportive care available
Best Supportive Care
|
Durvalumab Plus Tremelimumab and Best Supportive Care
n=118 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/61 • 24 months
|
2.5%
3/118 • 24 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/61 • 24 months
|
2.5%
3/118 • 24 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/61 • 24 months
|
3.4%
4/118 • 24 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
General disorders
Death NOS
|
0.00%
0/61 • 24 months
|
2.5%
3/118 • 24 months
|
|
General disorders
Fatigue
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
General disorders
Fever
|
0.00%
0/61 • 24 months
|
3.4%
4/118 • 24 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
General disorders
Other general disorders, administration site conditions
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Immune system disorders
Other immune system disorders
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Infections and infestations
Kidney infection
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/61 • 24 months
|
3.4%
4/118 • 24 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/61 • 24 months
|
4.2%
5/118 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Infections and infestations
Other infections and infestations
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Injury, poisoning and procedural complications
Intestinal stoma obstruction
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/61 • 24 months
|
2.5%
3/118 • 24 months
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Investigations
Creatinine increased
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Investigations
Lipase increased
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/61 • 24 months
|
1.7%
2/118 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/61 • 24 months
|
0.85%
1/118 • 24 months
|
Other adverse events
| Measure |
Best Supportive Care
n=61 participants at risk
Best supportive care available
Best Supportive Care
|
Durvalumab Plus Tremelimumab and Best Supportive Care
n=118 participants at risk
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
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
1.6%
1/61 • 24 months
|
8.5%
10/118 • 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
2/61 • 24 months
|
5.1%
6/118 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
29.5%
18/61 • 24 months
|
44.9%
53/118 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
23.0%
14/61 • 24 months
|
41.5%
49/118 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
9.8%
6/61 • 24 months
|
31.4%
37/118 • 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
2/61 • 24 months
|
9.3%
11/118 • 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
7/61 • 24 months
|
14.4%
17/118 • 24 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.2%
5/61 • 24 months
|
4.2%
5/118 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
27.9%
17/61 • 24 months
|
44.9%
53/118 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
9/61 • 24 months
|
25.4%
30/118 • 24 months
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
3.3%
2/61 • 24 months
|
8.5%
10/118 • 24 months
|
|
General disorders
Chills
|
1.6%
1/61 • 24 months
|
8.5%
10/118 • 24 months
|
|
General disorders
Edema limbs
|
19.7%
12/61 • 24 months
|
11.9%
14/118 • 24 months
|
|
General disorders
Fatigue
|
55.7%
34/61 • 24 months
|
77.1%
91/118 • 24 months
|
|
General disorders
Fever
|
9.8%
6/61 • 24 months
|
12.7%
15/118 • 24 months
|
|
General disorders
Flu like symptoms
|
1.6%
1/61 • 24 months
|
7.6%
9/118 • 24 months
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/61 • 24 months
|
5.1%
6/118 • 24 months
|
|
General disorders
Pain
|
14.8%
9/61 • 24 months
|
22.9%
27/118 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/61 • 24 months
|
11.9%
14/118 • 24 months
|
|
Investigations
Weight loss
|
1.6%
1/61 • 24 months
|
19.5%
23/118 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
36.1%
22/61 • 24 months
|
50.8%
60/118 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/61 • 24 months
|
6.8%
8/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.7%
12/61 • 24 months
|
21.2%
25/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/61 • 24 months
|
8.5%
10/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/61 • 24 months
|
5.9%
7/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/61 • 24 months
|
5.9%
7/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.6%
1/61 • 24 months
|
6.8%
8/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.9%
3/61 • 24 months
|
5.9%
7/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/61 • 24 months
|
5.9%
7/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
4/61 • 24 months
|
17.8%
21/118 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
3.3%
2/61 • 24 months
|
5.1%
6/118 • 24 months
|
|
Nervous system disorders
Dizziness
|
1.6%
1/61 • 24 months
|
5.1%
6/118 • 24 months
|
|
Nervous system disorders
Dysgeusia
|
4.9%
3/61 • 24 months
|
6.8%
8/118 • 24 months
|
|
Nervous system disorders
Headache
|
6.6%
4/61 • 24 months
|
12.7%
15/118 • 24 months
|
|
Nervous system disorders
Paresthesia
|
3.3%
2/61 • 24 months
|
9.3%
11/118 • 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
29.5%
18/61 • 24 months
|
33.9%
40/118 • 24 months
|
|
Psychiatric disorders
Anxiety
|
11.5%
7/61 • 24 months
|
11.0%
13/118 • 24 months
|
|
Psychiatric disorders
Confusion
|
4.9%
3/61 • 24 months
|
5.1%
6/118 • 24 months
|
|
Psychiatric disorders
Insomnia
|
18.0%
11/61 • 24 months
|
36.4%
43/118 • 24 months
|
|
Renal and urinary disorders
Hematuria
|
3.3%
2/61 • 24 months
|
5.1%
6/118 • 24 months
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
2/61 • 24 months
|
5.1%
6/118 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.4%
10/61 • 24 months
|
34.7%
41/118 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.5%
18/61 • 24 months
|
38.1%
45/118 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
1.6%
1/61 • 24 months
|
6.8%
8/118 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
2/61 • 24 months
|
10.2%
12/118 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/61 • 24 months
|
19.5%
23/118 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.9%
3/61 • 24 months
|
9.3%
11/118 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.2%
5/61 • 24 months
|
23.7%
28/118 • 24 months
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
1.6%
1/61 • 24 months
|
5.1%
6/118 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place