Neoadjuvant Immunotherapy With Durvalumab and Tremelimumab for Bladder Cancer Patients Ineligible for Cisplatin

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT03234153
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab (Imfinzi) — DRUG
    Durvalumab 1500 mg i.v. every 4 weeks in combination with Tremelimumab 75 mg i.v. every 4 weeks for a total of 4 cycles before surgery.
  • Tremelimumab — DRUG
    Tremelimumab 75 mg i.v. in combination with Durvalumab 1500 mg i.v. every 4 weeks every 4 weeks for a total of 4 cycles before surgery.

Study Details

The trial assess the safety and antitumor activity of the anti-PD-L1 antibody Durvalumab in combination with the anti-CTLA4 antibody Tremelimumab.

Key Dates

Start date
Jul 15, 2018
Status verified
Jun 2020
Primary completion
Nov 8, 2019
Completion
May 18, 2020

Study Design

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

Arms

  • Experimental: Durvalumab and Tremelimumab
    Durvalumab 1500 mg i.v. every 4 weeks in combination with Tremelimumab 75 mg i.v. every 4 weeks for a total of 4 cycles before surgery.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 16 weeks ]

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