Clinical trial · Interventional
Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma
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
NCT02558894CI-TRIAL-00034115completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI4736 monotherapy | Drug | — | UNRESOLVED |
| tremelimumab+MEDI4736 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MEDI4736 monotherapy
- description
- MEDI4736 via IV infusion.
- interventionNames
- Drug: MEDI4736 monotherapy
- type
- EXPERIMENTAL
- label
- tremelimumab+MEDI4736
- description
- MEDI4736+tremelimumab via IV infusion.
- interventionNames
- Drug: tremelimumab+MEDI4736
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- timeFrame
- From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDO'Reilly EM, Oh DY, Dhani N, Renouf DJ, Lee MA, Sun W, Fisher G, Hezel A, Chang SC, Vlahovic G, Takahashi O, Yang Y, Fitts D, Philip PA. Durvalumab With or Without Tremelimumab for Patients With Metastatic Pancreatic Ductal Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Oct 1;5(10):1431-1438. doi: 10.1001/jamaoncol.2019.1588. PMID 31318392