A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors
- Conditions
- Pancreatic ductal adenocarcinoma (PDAC)triple-negative breast cancer (TNBC)urethelial bladder cancer (UBC)100156741000499410006232
- Registration Number
- NL-OMON47002
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
- Willing to give valid written consent to provide a tumor biopsy, archival or fresh (preferred), for the purpose of establishing PD-L1 status and for exploratory biomarker analyses
- Patients affected by histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following; UBC, PDAC, TNBC.
- At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as >=10 mm in the longest diameter (except lymph nodes, which must have short axis >=15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans, preferably with IV contrast, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines.
- Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg hormone replacement therapy) is acceptable. Local treatment of isolated lesions for palliative intent is acceptable (eg local surgery or radiotherapy).
- Current or prior use of immunosuppressive medication within 14 days before the first dose of tremelimumab monotherapy, MEDI4736 monotherapy, or MEDI4736 + tremelimumab combination therapy.
- Active or prior documented autoimmune or inflammatory within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
*Patients with vitiligo or alopecia
*Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
* Any chronic skin condition that does not require systemic therapy
* Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca study physician
- Other malignancy within 5 years except for noninvasive malignancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective:<br /><br>To assess the efficacy of tremelimumab monotherapy in terms of objective<br /><br>response rate (ORR)<br /><br><br /><br>Outcome measure:<br /><br>ORR using Investigator assessments according to RECIST 1.1</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives:<br /><br><br /><br>To further assess the efficacy of tremelimumab monotherapy in terms of Duration<br /><br>of response (DoR), disease contrl rate (DCR), progression free survival (PFS),<br /><br>best objective response (BoR), and overall survival (OS) using Investigator<br /><br>assessments according to RECIST 1.1.<br /><br><br /><br>To assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab<br /><br>combination therapy after confirmed progressive disease (PD) on tremelimumab<br /><br>monotherapy or during follow-up in terms of ORR, DoR, DCR, PFS, BoR, and OS<br /><br>using Investigator assessments according to RECIST 1.1.</p><br>