A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT03122509 |
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Recruitment Status :
Completed
First Posted : April 20, 2017
Results First Posted : July 6, 2022
Last Update Posted : July 6, 2022
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Metastatic Colorectal Cancer |
| Interventions |
Drug: durvalumab Drug: tremelimumab Radiation: Radiotherapy (RT) Procedure: ablation |
| Enrollment | 25 |
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Durvalumab and Tremelimumab Plus Radiotherapy (RT) | Durvalumab and Tremelimumab Plus Ablation |
|---|---|---|
 Arm/Group Description |
Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion. RT will be initiated within 7 days after the first of durvalumab and tremelimumab. |
Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion. Ablation will be performed within 7 days after the first of durvalumab and tremelimumab. |
| Period Title: Overall Study | ||
| Started | 25 | 0 |
| Completed | 25 | 0 |
| Not Completed | 0 | 0 |
| Arm/Group Title | Durvalumab and Tremelimumab Plus Radiotherapy (RT) or Ablation | Durvalumab and Tremelimumab Plus Ablation | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion. RT will be initiated within 7 days after the first of durvalumab and tremelimumab. |
Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion. Ablation will be performed within 7 days after the first of durvalumab and tremelimumab. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 25 | 0 | 25 | |
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Baseline Analysis Population Description |
No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 25 participants | 0 participants | 25 participants | |
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55
(26 to 78)
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55
(26 to 78)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 0 participants | 25 participants | |
| Female |
12 48.0%
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12 48.0%
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| Male |
13 52.0%
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13 52.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 0 participants | 25 participants | |
| Hispanic or Latino |
1 4.0%
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1 4.0%
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| Not Hispanic or Latino |
24 96.0%
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24 96.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 0 participants | 25 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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| Asian |
4 16.0%
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4 16.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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| Black or African American |
1 4.0%
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1 4.0%
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| White |
19 76.0%
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19 76.0%
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| More than one race |
0 0.0%
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0 0.0%
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| Unknown or Not Reported |
1 4.0%
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1 4.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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| United States | Number Analyzed | 25 participants | 0 participants | 25 participants |
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25 100.0%
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25 100.0%
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| Name/Title: | Dr. Neil Segal, MD, PhD |
| Organization: | Memorial Sloan Kettering Cancer Center |
| Phone: | 646-888-4187 |
| EMail: | segaln@mskcc.org |
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03122509 |
| Other Study ID Numbers: |
17-139 |
| First Submitted: | April 18, 2017 |
| First Posted: | April 20, 2017 |
| Results First Submitted: | April 28, 2022 |
| Results First Posted: | July 6, 2022 |
| Last Update Posted: | July 6, 2022 |