Clinical trial · Interventional
A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
NCT03193190CI-TRIAL-00097729completedPhase 1 / Phase 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 Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
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 |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AB928 | Drug | — | UNRESOLVED |
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| BL-8040 | Drug | — | UNRESOLVED |
| Cobimetinib | Drug | Cobimetinib | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Nab-Paclitaxel | Drug |
Design
Arms and outcomes
Arms (12)
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1: Control (Nab-Paclitaxel and Gemcitabine)
- description
- Cohort 1: Participants will receive Nab-Paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle. Participants in the Cohort 1 control arm who experience disease progression will be given the option of enrolling into Cohort 2 (if open for enrollment), provided they meet eligibility criteria.
- interventionNames
- Drug: Nab-Paclitaxel
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
- description
- Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Selicrelumab 16 mg subcutaneous injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each 28-day cycle.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma * For patients in Cohort 1: no prior systemic treatment for PDAC * For patients in Cohort 2: disease progression during administration of either 5-FU- or gemcitabine-based first-line chemotherapy * Life expectancy greater than or equal to 3 months * Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing * Measurable disease (at least one target lesion) according to RECIST v1.1 * Adequate hematologic and end-organ function test results * Tumor accessible for biopsy * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as outlined for each specific treatment arm * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm Exclusion Criteria: * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedure (i.e., more than one time per month) * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * History of leptomeningeal disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Positive human immunodeficiency (HIV) test at screening or at any time prior to screening * Active hepatitis B or C virus infection or active tuberculosis * Severe infection within 4 weeks prior to initiation of study treatment * Prior allogeneic stem cell or solid organ transplantation * History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
References
Publications (2)
- DERIVEDKo AH, Oh DY, Lau J, Mhatre SK, Ci B, Machado R, Li S, Bretscher MT, Reyes-Rivera I, Zhu J, Zhang X, Patel J, Psioda MA, Ponz-Sarvise M. Investigational Use of Real-World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma From the Randomized Phase Ib/II MORPHEUS Trial. Clin Pharmacol Ther. 2025 Apr;117(4):1021-1029. doi: 10.1002/cpt.3528. Epub 2024 Dec 20. PMID 39707623
- DERIVEDKo AH, Kim KP, Siveke JT, Lopez CD, Lacy J, O'Reilly EM, Macarulla T, Manji GA, Lee J, Ajani J, Alsina Maqueda M, Rha SY, Lau J, Al-Sakaff N, Allen S, Lu D, Shemesh CS, Gan X, Cha E, Oh DY. Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform. Oncologist. 2023 Jun 2;28(6):553-e472. doi: 10.1093/oncolo/oyad022. PMID 36940261