Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Durvalumab (MEDI4736)Tremelimumabimmunotherapy17-511

Outcome Measures

Primary Outcomes (1)

Overall Response Rate
by RECIST 1.1
2 years

Study Arms (1)

combination of durvalumab and tremelimumab

EXPERIMENTAL

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).

Drug: durvalumab and tremelimumab

Interventions

durvalumab and tremelimumabDrug

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.

combination of durvalumab and tremelimumab

Named ingredients in these interventions

Linked from the registry description. Each source intervention is retained as reported.

Tremelimumab
In: durvalumab and tremelimumab
Durvalumab
In: durvalumab and tremelimumab

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
durvalumab and tremelimumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years at time of informed consent
Body weight \> 30 kg

Sponsors & Collaborators

AstraZeneca
Industrycollaborator
Memorial Sloan Kettering Cancer Center
Otherlead

Study Sites (4)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Memoral Sloan Kettering Westchester

Harrison, New York, 10604, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

durvalumabtremelimumab

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title: Dr. Samuel Funt, MD
Organization: Memorial Sloan Kettering Cancer Center

Study Officials

Samuel Funt, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

January 31, 2018

Actual (reported)

You may not qualify if:

Previous enrollment in the present study
Participation in another clinical study with an investigational product during the last 14 days
Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia"s Correction
Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA-4, including tremelimumab
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) \< 21 days prior to enrollment.
Major surgery within 28 days of starting study treatment. There is no minimum time requirement for minor procedures such as biopsy or vascular access placement.
Radiation within 14 days of starting study treatment
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Any unresolved toxicity from previous anti-cancer therapy must have resolved to at least ≤ Grade 1 (or baseline) at time of enrollment.
Patients with irreversible toxicity that is not reasonably expected to be exacerbated by treatment with durvalumab and tremelimumab may be included after consultation with the Principal Investigator or Co-Principal Investigator (e.g. alopecia, hearing loss, peripheral neuropathy).
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis, celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
Patients with vitiligo or alopecia
+16 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

combination of durvalumab and tremelimumab

Interventions

Named ingredients in these interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

combination of durvalumab and tremelimumab

Interventions

Named ingredients in these interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations