Trial Outcomes & Findings for A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer (NCT NCT03122509)

Last Updated: 2022-07-06

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

2 years

Results posted on

2022-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Durvalumab and Tremelimumab Plus Radiotherapy (RT) 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.	Durvalumab and Tremelimumab Plus Ablation 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.
Overall Study STARTED	25	0
Overall Study COMPLETED	25	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab and Tremelimumab Plus Radiotherapy (RT) or Ablation n=25 Participants 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.	Durvalumab and Tremelimumab Plus Ablation 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 n=25 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	—	55 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	—	12 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	—	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	—	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	—	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants	—	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: No participants were enrolled on the Durvalumab and Tremelimumab + ablation arm.

Outcome measures

Outcome measures
Measure	Durvalumab and Tremelimumab Plus Radiotherapy (RT) n=25 Participants 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.
Overall Response Rate Complete Response	0 Participants
Overall Response Rate Partial Response	2 Participants
Overall Response Rate Stable Disease	3 Participants
Overall Response Rate Progressive Disease	19 Participants
Overall Response Rate Unevaluable	1 Participants

Adverse Events

Durvalumab and Tremelimumab Plus Radiotherapy (RT) or Ablation

Serious events: 9 serious events

Other events: 6 other events

Deaths: 1 deaths

Durvalumab and Tremelimumab Plus Ablation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab and Tremelimumab Plus Radiotherapy (RT) or Ablation n=25 participants at risk 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.	Durvalumab and Tremelimumab Plus Ablation 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.
Infections and infestations Biliary tract infection	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Investigations Blood bilirubin increased	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Gastrointestinal disorders Colitis	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Infections and infestations Enterocolitis infectious	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
General disorders Fever	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	8.0% 2/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
General disorders Gen disorders & admin site conditions Other, spec	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Metabolism and nutrition disorders Hyperglycemia	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Gastrointestinal disorders Ileus	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Gastrointestinal disorders Rectal hemorrhage	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Infections and infestations Sepsis	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Infections and infestations Upper respiratory infection	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.

Other adverse events

Other adverse events
Measure	Durvalumab and Tremelimumab Plus Radiotherapy (RT) or Ablation n=25 participants at risk 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.	Durvalumab and Tremelimumab Plus Ablation 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.
Metabolism and nutrition disorders Hyperglycemia	8.0% 2/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Investigations Alanine aminotransferase increased	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Investigations Aspartate aminotransferase increased	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Investigations Platelet count decreased	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.
Investigations Alkaline phosphatase increased	4.0% 1/25 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.	— 0/0 • 2 years No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.

Additional Information

Dr. Neil Segal, MD, PhD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place