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

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

A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Metastatic, Non-transitional Cell Carcinoma of the Urothelial Tract

NCT03430895•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years at time of informed consent
•Body weight \> 30 kg
•Histologically or cytologically confirmed small cell carcinoma, squamous cell carcinoma or adenocarcinoma (confirmed at MSKCC) of the bladder, ureter, urethra, urachus, or renal pelvis. Patients with squamous cell carcinoma and adenocarcinoma are required to have a predominant squamous or adenocarcinoma component as reviewed by the pathologist at MSKCC. However, if any element of small cell or neuroendocrine differentiation is present, the patients will be classified as small cell/neuroendocrine.
•Confirmation of availability of sufficient tissue from a prior surgery for correlative studies is required prior to enrollment. Patients must have representative non-TCC or the urothelial tract FFPE archival tumor specimens (tumor blocks or 30 unstained slides; preference for tumor blocks). These samples may be submitted between the time of consent and the start of treatment. Patients with \< 30 slides may be enrolled after discussion with the principal or co-principal investigators.
•Clinical evidence of metastatic (T4b, any N; any T, N2-3; M1) disease.
•Life expectancy of 12 weeks of greater based on assessment by the treating investigator.
•Evidence of measurable disease by RECIST 1.1.
•Patients with small cell carcinoma must have progressed after at least one prior systemic therapy. Patients with squamous cell carcinoma or adenocarcinoma may be previously untreated or have progressed after prior systemic therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen. NOTE: There is no maximum number of prior treatments allowed.
•Patients with brain metastases are allowed onto the study as long as patients have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic. Subjects with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
+21 more criteria

Exclusion Criteria

•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
+21 more criteria

Locations (4)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memoral Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

January 31, 2018

Primary Completion Date

February 10, 2021

Completion Date

February 10, 2021

Last Updated

December 1, 2021

Enrollment

ACTUAL participants

Conditions

Non-Transitional Cell Carcinoma of the Urothelial TractSmall Cell of the BladderAdenocarcinoma of the BladderSquamous Cell Carcinoma of the BladderMetastatic Bladder Cancer

Interventions

durvalumab and tremelimumab

DRUG