Phase 2
Completed N=65
Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma
Source: ClinicalTrials.gov NCT02558894 ↗Enrolled (actual)
65
Serious AEs
31.3%
Results posted
Aug 2018
Primary outcomePrimary: Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) — 3.1; 0; 3.1; 6.1 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
3.1; 0; 3.1; 6.1 | — |
| SECONDARY Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1 |
1.5; 1.5 | — |
| SECONDARY PFS Rate at 3 Months and at 6 Months |
9.4; 10.9; 9.4; 3.6 | — |
| SECONDARY Overall Survival (OS) |
3.1; 3.6 | — |
| SECONDARY Survival Status, Presented as OS Rate, at 6 Months and at 12 Months |
36.2; 34.9; 8.8; 6.3 | — |
| SECONDARY Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1 |
9.4; 6.1; 6.3; 0; 3.1; 0 | — |
| SECONDARY Pharmacokinetics (PK) of Durvalumab (MEDI4736) |
217.338; 566.078; 562.218; 100.417; 98.668; 236.205 | — |
| SECONDARY PK of Tremelimumab |
13.114; 24.477; 4.880; 8.753; 21.150 | — |
| SECONDARY Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) |
1; 5; 0; 3; 0; 0 | — |
| SECONDARY Presence of ADAs for Tremelimumab |
2; 0; 1; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria: -
- Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
- Eastern Cooperative Oncology Group 0 or 1
- 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
- Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
- History of leptomeningeal carcinomatosis
- Ascites requiring intervention
- Brain metastases or spinal cord compression.
Data sourced from ClinicalTrials.gov (NCT02558894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.