A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus–Pancreatic Cancer)

Start 23 Nov 2017 · End 27 Feb 2025 · Status Ended · 1 EU/EEA countries · 3 sites · Protocol WO39608

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ended

Participants planned 282

Countries 1

Sites 3

Pancreatic ductal adenocarcinoma (PDAC)

To evaluate the efficacy of immunotherapy-based treatment combinations

Key facts

Sponsor: F. Hoffmann-La Roche AG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 23 Nov 2017 → 27 Feb 2025
Decision date (initial): 2024-04-04
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: F. Hoffmann-La Roche AG

External identifiers

EU CT number: 2024-511271-15-00
EudraCT number: 2016-004126-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of immunotherapy-based treatment combinations

Secondary objectives 2

To evaluate the efficacy (progression free survival, overall survival, overall survival at specific timepoints, duration of response, and disease control) of immunotherapy-based treatment combinations
To evaluate the safety of immunotherapy-based treatment combinations

Conditions and MedDRA coding

Pancreatic ductal adenocarcinoma (PDAC)

Version	Level	Code	Term	System organ class
21.0	LLT	10033604	Pancreatic cancer	10029104

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Multiple Immunotherapy Based Treatments Combinations Study for Patients with 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 (MORPHEUSPANCREATIC CANCER)	Randomised Controlled	None		Arm 1/ Cohort 1 - Control: Nab-paclitaxel and gemcitabine Arm 2/ Cohort 1 - Atezo - Chemo - Bev: Atezolizumab, nab-paclitaxel, gemcitabine, and bevacizumab Arm 3/ Cohort 1 - Atezo - Chemo - Tira: Atezolizumab, nab-paclitaxel, gemcitabine, and tiragolumab Arm 4/Cohort 1 - Atezo - Chemo - TCZ: Atezolizumab, nab-paclitaxel, gemcitabine, and tocilizumab

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Histologically or cytologically confirmed metastatic PDAC
For patients in Cohort 1: no prior systemic treatment for PDAC
For patients in Cohort 2: disease progression during administration of either 5-fluorouracil or gemcitabine-based first-line chemotherapy in the metastatic or locally advanced setting and, for patients treated in the locally advanced setting, occurrence of metastasis within 6 months after initiation of chemotherapy
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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Adequate hematologic and end-organ function test results

Exclusion criteria 6

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 scan
Positive HIV test at screening or at any time prior to screening
Active hepatitis B or C virus infection or active tuberculosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response

Secondary endpoints 8

1. Progression free survival
2. Overall survival
3. Overall survival at specific timepoints
4. Duration of response
5. Disease control
6. Incidence, nature, and severity of adverse events and laboratory abnormalities
7. Change from baseline in vital signs and ECG parameters
8. Change from baseline in targeted clinical laboratory test results

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Avastin 25 mg/ml concentrate for solution for infusion.

PRD2153902 · Product

Active substance: Bevacizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Authorisation status: Authorised
ATC code: L01FG01 — -
Marketing authorisation: EU/1/04/300/002
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Relabeled for clinical trial use

RoActemra 20 mg/mL concentrate for solution for infusion

PRD2154622 · Product

Active substance: Tocilizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Authorisation status: Authorised
ATC code: L04AC07 — -
Marketing authorisation: EU/1/08/492/003
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Secondary packaging and labeling appropriate for clinical trial use

Tiragolumab

PRD7846761 · Product

Active substance: Tiragolumab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Authorisation status: Not Authorised
MA holder: F. HOFFMANN-LA ROCHE LTD
Paediatric formulation: No
Orphan designation: No

Atezolizumab

SUB178312 · Substance

Active substance: Atezolizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 4

Abraxane 5 mg/ml powder for dispersion for infusion.

PRD9254301 · Product

Active substance: Paclitaxel Albumin-Bound
Substance synonyms: PACLITAXEL ALBUMINE-BOUND
Pharmaceutical form: DISPERSION FOR INFUSION
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01CD01 — PACLITAXEL
Marketing authorisation: EU/1/07/428/001
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Relabeling for clinical trial use

Gemcitabin Kabi 38 mg/ml Pulver zur Herstellung einer Infusionslösung

PRD707659 · Product

Active substance: Gemcitabine
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01BC05 — GEMCITABINE
Marketing authorisation: 74410.00.00
MA holder: FRESENIUS KABI DEUTSCHLAND GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Re-packaging and re-labelling for clinical trial use

Gemcitabin-GRY 1000 mg Pulver zur Herstellung einer Infusionslösung

PRD472665 · Product

Active substance: Gemcitabine Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01BC05 — GEMCITABINE
Marketing authorisation: 71399.00.00
MA holder: TEVA GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Re-packaging and re-labelling for clinical trial use

Gemcitabin AqVida 38 mg/ml Pulver zur Herstellung einer Infusionslösung

PRD1744676 · Product

Active substance: Gemcitabine
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01BC05 — GEMCITABINE
Marketing authorisation: 79590.00.00
MA holder: AQVIDA GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Re-packaging and re-labelling for clinical trial use

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation: F. Hoffmann-La Roche AG
Address: Grenzacherstrasse 124
City: Basel
Postcode: 4058
Country: Switzerland

Scientific contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Public contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Third parties 18

Organisation	City, country	Duties
Labcorp Central Laboratory Services SARL ORG-100011524	Meyrin, Switzerland	Other, Laboratory analysis
Pharmaceutical Product Development LLC ORG-100016999	Richmond, United States	Other, Laboratory analysis
Icon Development Solutions LLC ORG-100012400	Whitesboro, United States	Other, Laboratory analysis
Syneos Health Inc. ORG-100008382	Princeton, United States	Other, Laboratory analysis
Neogenomics Inc. ORG-100044076	Fort Myers, United States	Other, Laboratory analysis
Nordic Bioscience A/S ORG-100009315	Herlev, Denmark	Other, Laboratory analysis
QPS Netherlands B.V. ORG-100009393	Groningen, Netherlands	Other, Laboratory analysis
CellCarta ORG-100039881	Antwerp, Belgium	Other, Laboratory analysis
Fortrea Inc. ORG-100012602	Princeton, United States	Other, Laboratory analysis
Microconstants Inc. ORG-100012792	San Diego, United States	Other, Laboratory analysis
Almac Group Limited ORG-100011829	Craigavon, United Kingdom (Northern Ireland)	Other
Q Squared Solutions LLC ORG-100043195	Durham, United States	Other, Laboratory analysis
Frontage Laboratories Inc. ORG-100011515	Exton, United States	Other, Laboratory analysis
Discovery Life Sciences Biomarker Services GmbH ORG-100042520	Kassel, Germany	Other, Laboratory analysis
Ventana Medical Systems Inc. ORG-100043193	Oro Valley, United States	Other, Laboratory analysis
Farmaprojects S.A.U. ORG-100002872	Barcelona, Spain	Other, Laboratory analysis
MicroCoat Biotechnologie GmbH ORG-100031937	Bernried Am Starnberger See, Germany	Other, Laboratory analysis
Precision For Medicine Inc. ORG-100041895	Frederick, United States	Other, Laboratory analysis

Locations

1 EU/EEA country · 3 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Ended	29	3
Rest of world United States, Korea, Republic of	—	253	—

Investigational sites

Spain

3 sites · Ended

Hospital Universitari Vall D Hebron

Oncology, Edificio Materno-Infantil, Passeig De La Vall D'Hebron 119-129, Barcelona

Clinica Universidad De Navarra

Oncology, Avenue Pio XII 36, 31008, Pamplona

Hospital General Universitario Gregorio Maranon

Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Spain	2017-11-23	2025-02-07	2017-12-28	2023-09-20

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Title	Submission date	Status	Type
WO39608 final results summary SUM-106151	2025-11-13T08:40:17	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
LPS_WO39608_Morpheus Pancreatic_FINAL Analysis_30Sept 2025_EN	2026-02-09T19:39:36	Submitted	Laypersons Summary of Results

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Laypersons summary of results (for publication)	LPS_WO39608_Morpheus Pancreatic_FINAL Analysis_30Sept 2025_EN	N/A
Summary of results (for publication)	WO39608 final results summary	NA

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-03-20	Spain	Acceptable 2024-04-04	2024-04-04