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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03430895
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of the Bladder
  • Metastatic Bladder Cancer
  • Non-Transitional Cell Carcinoma of the Urothelial Tract
  • Small Cell of the Bladder
  • Squamous Cell Carcinoma of the Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • durvalumab and tremelimumab — DRUG
    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.

Study Details

This study is being done test to test the safety and effectiveness of durvalumab combined with tremelimumab in patients who have a rare form of cancer of the urinary tract.

Key Dates

Start date
Jan 31, 2018
Status verified
Feb 2021
Primary completion
Feb 10, 2021
Completion
Feb 10, 2021

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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).

Primary Outcome Measure

Overall Response Rate [ Time Frame: 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering CommackCommackNew York11725-
Memoral Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Commack· Commack, NYMemoral Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

Related Studies