Phase II trial of durvalumab (Medi4736) plus tremelimumab with concurrent radiotherapy in patients with localized muscle invasive bladder cancer treated with a selective bladder preservation approach - INMUNOPRESERVE

Spanish Oncology Genitourinary Group0 sites32 target enrollmentJune 21, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Spanish Oncology Genitourinary Group
Enrollment: 32
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 21, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Spanish Oncology Genitourinary Group

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with urothelial carcinoma of the bladder, in clinical stages T2\-4a N0 M0, who are
•not candidates for radical cystectomy by medical reasons, refusal or patient’s choice.
•1\. Patients must have signed the informed consent prior to undergoing any study procedure.
•2\. Patients must be 18 years of age or older.
•3\. Patients must have ECOG performance status 0 or 1\.
•4\. A paraffin\-embedded tumor sample must be available for the associate molecular study.
•5\. Body weight \>30 Kg.
•6\. Adequate normal organ and marrow function as defined in section 4\.1 of this protocol.
•7\. Evidence of post\-menopausal status or negative urinary or serum pregnancy test for female pre\-menopausal patients, according to what is detailed in section 4\.1 of this protocol.
•8\. Patient is willing and able to comply with the protocol for the duration of the study.

Exclusion Criteria

•1\. Involvement in the planning and/or conduct of the study (applies to both Sponsor staff and/or
•staff at the study site)
•2\. Participation in another clinical study with an investigational product during the last 30 days.
•3\. Concurrent enrolment in another clinical study unless it is an observational (non\-interventional)
•clinical study or during the follow\-up period of an interventional study.
•4\. Previous treatment with radiotherapy to the bladder, systemic chemotherapy or immune checkpoint inhibitors. Prior intravesical Bacillus Calmette\-Guérin (BCG) treatment for non\- muscle invasive bladder cancer is allowed, 28 days prior to study.
•5\. Presence of regional lymph node or metastatic extension of the disease.
•6\. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \=470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) \<\>.
•7\. Any unresolved toxicity NCI CTCAE Grade \=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with Grade \=2 neuropathy will be evaluated on a case\-by\-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
•8\. Any concurrent chemotherapy, investigational product (IP) other than studied in this protocol, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non–cancer\-related conditions (e.g., hormone replacement therapy) is acceptable.