Trial Outcomes & Findings for Evaluating Immune Therapy, Durvalumab (MEDI4736) With Tremelimumab for Metastatic, Non-transitional Cell Carcinoma of the Urinary Tract (NCT NCT03430895)

NCT ID: NCT03430895

Last Updated: 2021-12-01

Results Overview

by RECIST 1.1

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2021-12-01

Participant Flow

Participant milestones

Measure	Combination of Durvalumab and Tremelimumab Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months). durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Combination of Durvalumab and Tremelimumab Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months). durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses.

Overall Study Not Treated

2

Baseline Characteristics

Evaluating Immune Therapy, Durvalumab (MEDI4736) With Tremelimumab for Metastatic, Non-transitional Cell Carcinoma of the Urinary Tract

Baseline characteristics by cohort

Measure	Combination of Durvalumab and Tremelimumab n=15 Participants Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months). durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

by RECIST 1.1

Outcome measures

Measure	Combination of Durvalumab and Tremelimumab n=15 Participants Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months). durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses.
Overall Response Rate Not treated/Not Evaluable	2 Participants
Overall Response Rate Stable Disease	2 Participants
Overall Response Rate Progressive Disease	11 Participants

Adverse Events

Combination of Durvalumab and Tremelimumab

Serious events: 5 serious events

Other events: 14 other events

Deaths: 9 deaths

Serious adverse events

Measure	Combination of Durvalumab and Tremelimumab n=15 participants at risk Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months). durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • 1 year
Gastrointestinal disorders Ascites	6.7% 1/15 • 1 year
General disorders Death NOS	20.0% 3/15 • 1 year
Gastrointestinal disorders Dysphagia	6.7% 1/15 • 1 year
Metabolism and nutrition disorders Hypercalcemia	13.3% 2/15 • 1 year
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • 1 year
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 1/15 • 1 year
Surgical and medical procedures Surgical and medical procedures - Other, specify	6.7% 1/15 • 1 year
Vascular disorders Thromboembolic event	13.3% 2/15 • 1 year
Gastrointestinal disorders Vomiting	6.7% 1/15 • 1 year

Other adverse events

Measure	Combination of Durvalumab and Tremelimumab n=15 participants at risk Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months). durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses.
Metabolism and nutrition disorders Hyperglycemia	86.7% 13/15 • 1 year
Blood and lymphatic system disorders Anemia	73.3% 11/15 • 1 year
Metabolism and nutrition disorders Hypoalbuminemia	60.0% 9/15 • 1 year
Metabolism and nutrition disorders Hypomagnesemia	60.0% 9/15 • 1 year
Investigations Lymphocyte count decreased	60.0% 9/15 • 1 year
Investigations Alanine aminotransferase increased	53.3% 8/15 • 1 year
Investigations Alkaline phosphatase increased	53.3% 8/15 • 1 year
Investigations Aspartate aminotransferase increased	53.3% 8/15 • 1 year
Investigations White blood cell decreased	53.3% 8/15 • 1 year
Metabolism and nutrition disorders Hypocalcemia	46.7% 7/15 • 1 year
Metabolism and nutrition disorders Hyponatremia	46.7% 7/15 • 1 year
Investigations Platelet count decreased	40.0% 6/15 • 1 year
Investigations Activated partial thromboplastin time prolonged	40.0% 6/15 • 1 year
Metabolism and nutrition disorders Hyperkalemia	40.0% 6/15 • 1 year
Investigations INR increased	40.0% 6/15 • 1 year
Metabolism and nutrition disorders Hypercalcemia	33.3% 5/15 • 1 year
Metabolism and nutrition disorders Hypoglycemia	33.3% 5/15 • 1 year
Investigations Creatinine increased	26.7% 4/15 • 1 year
Metabolism and nutrition disorders Hypokalemia	26.7% 4/15 • 1 year
Metabolism and nutrition disorders Hypophosphatemia	26.7% 4/15 • 1 year
Investigations Neutrophil count decreased	26.7% 4/15 • 1 year
Investigations Serum amylase increased	26.7% 4/15 • 1 year
Investigations Blood bilirubin increased	20.0% 3/15 • 1 year
Investigations Lipase increased	20.0% 3/15 • 1 year
Metabolism and nutrition disorders Hypermagnesemia	6.7% 1/15 • 1 year
Metabolism and nutrition disorders Hypernatremia	6.7% 1/15 • 1 year

Additional Information

Dr. Samuel Funt, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4770

Email: funts@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place