Trial · NCT02870920
Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
NCT02870920, Phase 2, Completed, Canadian Cancer Trials Group; results first posted 2021-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer. Trials, record NCT02870920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02870920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
- NCT number
- NCT02870920
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- Canadian Cancer Trials Group
- Conditions
- Colorectal Cancer
- Interventions
- Tremelimumab, Durvalumab, Best Supportive Care
- First posted
- 2016-08-17
- Last updated
- 2023-12-08
- Results first posted
- 2021-01-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 24 months | 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. |
| Secondary | Progression-free Survival | 24 months | 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. |
| Secondary | Objective Response Rate | 24 months | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 24 months | All randomized patients. | months | MEDIAN |
| SECONDARY | Progression-free Survival | 24 months | All randomized patients | Months | MEDIAN |
| SECONDARY | Objective Response Rate | 24 months | All randomized patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Best Supportive Care | 4.1 | 90% Confidence Interval 3.3 to 6.0 | months | |
| Overall Survival | Durvalumab Plus Tremelimumab and Best Supportive Care | 6.6 | 90% Confidence Interval 6.0 to 7.4 | months | |
| Progression-free Survival | Best Supportive Care | 1.9 | 90% Confidence Interval 1.8 to 1.9 | Months | |
| Progression-free Survival | Durvalumab Plus Tremelimumab and Best Supportive Care | 1.8 | 90% Confidence Interval 1.8 to 1.9 | Months | |
| Objective Response Rate | Best Supportive Care | Responded | 0 | Participants | |
| Objective Response Rate | Durvalumab Plus Tremelimumab and Best Supportive Care | Responded | 1 | Participants | |
| Objective Response Rate | Best Supportive Care | Not responded | 61 | Participants | |
| Objective Response Rate | Durvalumab Plus Tremelimumab and Best Supportive Care | Not responded | 118 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Best Supportive Care | 61 | |
| Overall Study | STARTED | Durvalumab Plus Tremelimumab and Best Supportive Care | 119 | |
| Overall Study | COMPLETED | Best Supportive Care | 61 | |
| Overall Study | COMPLETED | Durvalumab Plus Tremelimumab and Best Supportive Care | 119 | |
| Overall Study | NOT COMPLETED | Best Supportive Care | 0 | |
| Overall Study | NOT COMPLETED | Durvalumab Plus Tremelimumab and Best Supportive Care | 0 |
Source ClinicalTrials.gov
Adverse events208
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypothyroidism | Endocrine disorders | Best Supportive Care | 1 | 61 | |
| other | Hypothyroidism | Endocrine disorders | Durvalumab Plus Tremelimumab and Best Supportive Care | 10 | 118 | |
| other | Abdominal distension | Gastrointestinal disorders | Best Supportive Care | 2 | 61 | |
| other | Abdominal distension | Gastrointestinal disorders | Durvalumab Plus Tremelimumab and Best Supportive Care | 6 | 118 | |
| other | Abdominal pain | Gastrointestinal disorders | Best Supportive Care | 18 | 61 | |
| other | Abdominal pain | Gastrointestinal disorders | Durvalumab Plus Tremelimumab and Best Supportive Care | 53 | 118 | |
| other | Constipation | Gastrointestinal disorders | Best Supportive Care | 14 | 61 | |
| other | Constipation | Gastrointestinal disorders | Durvalumab Plus Tremelimumab and Best Supportive Care | 49 | 118 | |
| other | Diarrhea | Gastrointestinal disorders | Best Supportive Care | 6 | 61 | |
| other | Diarrhea | Gastrointestinal disorders | Durvalumab Plus Tremelimumab and Best Supportive Care | 37 | 118 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Best Supportive Care | 54 | 61 |
| Total, all-cause mortality | Durvalumab Plus Tremelimumab and Best Supportive Care | 100 | 118 |
| Total, other adverse events | Best Supportive Care | 51 | 61 |
| Total, other adverse events | Durvalumab Plus Tremelimumab and Best Supportive Care | 116 | 118 |
| Total, serious adverse events | Best Supportive Care | 0 | 61 |
| Total, serious adverse events | Durvalumab Plus Tremelimumab and Best Supportive Care | 55 | 118 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Best Supportive Care vs Durvalumab Plus Tremelimumab and Best Supportive Care: deaths from any cause | Trial comparisons |
| Best Supportive Care vs Durvalumab Plus Tremelimumab and Best Supportive Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02870920
GET https://conductscience.org/api/trials/v1/NCT02870920/events?page=2