Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

• Status: Completed
• Trial end date: 2017-06-15
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Durvalumab; Tremelimumab

Criteria

Inclusion Criteria: -

1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen

2. Eastern Cooperative Oncology Group 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, investigational product , biologic, or hormonal therapy for cancer treatment.

2. History of leptomeningeal carcinomatosis

3. Ascites requiring intervention

4. Brain metastases or spinal cord compression.