A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Phase 2
Completed
- Conditions
- Pancreatic cancer10015674
- Registration Number
- NL-OMON42744
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
1.Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
2. ECOG 0 or 1
3. 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) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements
Exclusion Criteria
1.Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
treatment.
2. History of leptomeningeal carcinomatosis
3. Ascites requiring intervention
4. Brain metastases or spinal cord compression.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab<br /><br>combination therapy in terms of ORR according to RECIST1:1</p><br>
- Secondary Outcome Measures
Name Time Method <p>To further assess the efficacy of the combination of MEDI4736 and tremelimumab<br /><br>and MEDI4736 alone in terms of DoR, DCR, PFS, PFS3, PFS6, OS, OS6, and OS12<br /><br><br /><br>To investigate the immunogenicity of MEDI4736 monotherapy and MEDI4736 +<br /><br>tremelimumab combination therapy<br /><br><br /><br>To assess the PK of MEDI4736 monotherapy and MEDI4736 + tremelimumab<br /><br>combination therapy<br /><br><br /><br>To assess the safety and tolerability profile of MEDI4736 monotherapy and<br /><br>MEDI4736 + tremelimumab combination therapy</p><br>