Pancreatic AdenocarcinomaPhase 1/2NCT03193190

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

A Phase 1/2 study testing Nab-Paclitaxel, Gemcitabine and Oxaliplatin in people with Pancreatic Adenocarcinoma, run by Hoffmann-La Roche at 23 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Adenocarcinoma
What is being tested?: Nab-Paclitaxel, Gemcitabine and Oxaliplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: 23 sitesin 5 countries
Study dates: 5 Jul 2017to 27 Feb 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

23 sites in 5 countries.

Country

City, postcode or hospital

23 sites in 5 countries

United States12 sites

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Uni of Chicago Medical Center
Chicago, Illinois, 60637
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
MorristownMedicalCenter
Morristown, New Jersey, 07962
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510
Columbia University
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Oregon Health and Science University
Portland, Oregon, 97239
Helen Diller Fam Comp Can Ctr
San Francisco, California, 94158
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007

Other trials in United States

Spain4 sites

Hospital Universitario Vall d Hebron
Barcelona, 08035
Hosp. G. U Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, 28037
Clínica Universidad de Navarra
Pamplona, Navarre, 31008

Other trials in Spain

Japan3 sites

National Cancer Center Hospital East
Chiba, 277-8577
Kanagawa Cancer Center
Kanagawa, 241-8515
National Cancer Center Hospital
Tokyo, 104-0045

Other trials in Japan

South Korea3 sites

Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351

Other trials in South Korea

Germany1 site

Universitätsklinikum Essen
Essen, 45122

Other trials in Germany

About this study

Official title: 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)

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: Pancreatic Adenocarcinoma
Being tested: Nab-Paclitaxel, Gemcitabine, Oxaliplatin, Leucovorin, Fluorouracil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nab-PaclitaxelDrug
Nab-Paclitaxel will be administered as per the schedule specified in the respective arm.
GemcitabineDrug
Gemcitabine will be administered as per the schedule specified in the respective arm.
OxaliplatinDrug
Oxaliplatin will be administered as per the schedule specified in the respective arm.
LeucovorinDrug
Leucovorin will be administered as per the schedule specified in the respective arm.
FluorouracilDrug
Fluorouracil will be administered as per the schedule specified in the respective arm.
AtezolizumabDrug
Atezolizumab will be administered as per the schedule specified in the respective arm.
CobimetinibDrug
Cobimetinib will be administered as per the schedule specified in the respective arm.
PEGPH20Drug
PEGPH20 will be administered as per the schedule specified in the respective arm.
BL-8040Drug
BL-8040 will be administered as per the schedule specified in the respective arm.
SelicrelumabDrug
Selicrelumab will be administered as per the schedule specified in the respective arm.
BevacizumabDrug
Bevacizumab will be administered as per the schedule specified in the respective arm.
RO6874281Drug
RO6874281 will be administered as per the schedule specified in the respective arm
AB928Drug
AB928 will be administered as per the schedule specified in the respective arm.
TiragolumabDrug
Tiragolumab will be administered as per the schedule specified in the respective arm.
TocilizumabDrug
Tocilizumab will be administered as per the schedule specified in the respective arm.

Study groups in NCT03193190
Study group	Role	What they receive
Cohort 1: Control (Nab-Paclitaxel and Gemcitabine)	Active comparator	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. Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine
Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab	Experimental	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. Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Atezolizumab; Drug: Selicrelumab
Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab	Experimental	Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Bevacizumab 10 mg/kg 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. Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Atezolizumab; Drug: Bevacizumab
Cohort 1: Atezolizumab + Chemotherapy + AB928	Experimental	Cohort 1: Participant will receive AB928 150 mg orally once daily on Days 1 to 28 of each 28 day cycle; 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. Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Atezolizumab; Drug: AB928
Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab	Experimental	Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Tiragolumab 420 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. Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Atezolizumab; Drug: Tiragolumab
Cohort 2: Atezolizumab + Cobimetinib	Experimental	Cohort 2: Participants will receive Cobimetinib 60 milligrams (mg) once daily orally on Days 1-21 of each 28-day cycle; and Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arm is open for enrollment. Receives: Drug: Atezolizumab; Drug: Cobimetinib
Cohort 2: Atezolizumab + PEGPH20	Experimental	Cohort 2: Participants will receive PEGPH20 3 micrograms per kilogram (mcg/kg) IV infusion on Days 1, 8 and 15 of each 21-day cycle; and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment. Receives: Drug: Atezolizumab; Drug: PEGPH20
Cohort 2: Atezolizumab + BL-8040	Experimental	Cohort 2: Participants will receive BL-8040 1.25 milligrams per kilogram (mg/kg) subcutaneously (SC) on Days 1-5 of the first week, followed by combination treatment consisting of BL-8040 1.25 mg/kg SC three times a week on non-consecutive days and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment. Receives: Drug: Atezolizumab; Drug: BL-8040
Cohort 2: Atezolizumab + RO6874281 every 2 weeks	Experimental	Cohort 2: Participants will receive Atezolizumab 840 mg IV infusion on days 1 and 15 of each 28 day cycle; RO6874281 will be administered 10 mg by IV infusion on day 1 and 15 mg on days 8, 15, and 22 for cycle 1 (28 day cycle). RO6874281 will be administered 15 mg by IV infusion on days 1 and 15 of each subsequent 28 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment. Receives: Drug: Atezolizumab; Drug: RO6874281
Cohort 2: Atezolizumab + RO6874281 every 3 weeks	Experimental	Cohort 2: Participants will receive Atezolizumab 1200 mg IV infusion on Day 1 of each 21 day cycle; and RO6874281 10 mg by IV infusion on day 1 of each 21 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment. Receives: Drug: Atezolizumab; Drug: RO6874281
Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)	Active comparator	Cohort 2: Participants who progressed on a prior fluoropyrimidine-based regimen 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 who progressed on a prior gemcitabine-based regimen will receive 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6). Participants will receive Oxaliplatin 85 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Leucovorin 400 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Fluorouracil 400 mg/m^2 IV push on Days 1 and 15 of each 28 day cycle; and Fluorouracil 2400 mg/m^2 IV continuous infusion over 46 hours on Days 1 and 2 and on Days 15 and 16 of each 28 day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment. Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil
Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab	Experimental	Cohort 1: Participants will receive Tocilizumab 8 mg/kg IV infusion on Day 1 of each 28 day cycle; Atezolizumab 1680 mg IV infusion on Day 1 of each 28 day cycle; 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. Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Atezolizumab; Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.
Measured: Up to 33.3 months

Secondary outcomes (6)

Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: Up to 33.3 months
Stage 1: Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (K-M) method was used to estimate PFS.
Measured: Up to 33.3 months
Stage 1: Overall Survival (OS), as Determined by Investigator According to RECIST v1.1
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS.
Measured: Up to 33.3 months
Stage 1: OS Rate at Month 6
OS was defined as the time from randomization to death from any cause. OS rate at 6 months was defined as the percentage of participants who did not experience death from any cause at 6 months from randomization. K-M method was used to estimate OS. Percentages have been rounded off.
Measured: Month 6
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1
DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate DOR.
Measured: Up to 33.3 months
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1
DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages have been rounded off.
Measured: Up to 33.3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201727 Feb 2025

First posted20 Jun 2017
Study start5 Jul 2017
Primary completion27 Feb 2025
Study completion27 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03193190
Sponsor's protocol ID: WO39608
Other IDs: 2016-004126-42, 2016
Status last verified: Nov 2025
First submitted: 9 Jun 2017
Last updated: 21 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ko 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.
PubMed 39707623
Ko 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.
PubMed 36940261

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT03193190
Acronym / sponsor ID: WO39608
Conditions: Pancreatic Adenocarcinoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 5 Jul 2017 (actual)
Primary completion: 27 Feb 2025 (actual)
Study completion: 27 Feb 2025 (actual)
First posted: 20 Jun 2017 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Cohort 1: Control (Nab-Paclitaxel and Gemcitabine)	Active comparator	Drug: Nab-Paclitaxel, Drug: GemcitabineCohort 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.
Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab	Experimental	Drug: Nab-Paclitaxel, Drug: Gemcitabine, Drug: Atezolizumab, Drug: SelicrelumabCohort 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.
Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab	Experimental	Drug: Nab-Paclitaxel, Drug: Gemcitabine, Drug: Atezolizumab, Drug: BevacizumabCohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Bevacizumab 10 mg/kg 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.
Cohort 1: Atezolizumab + Chemotherapy + AB928	Experimental	Drug: Nab-Paclitaxel, Drug: Gemcitabine, Drug: Atezolizumab, Drug: AB928Cohort 1: Participant will receive AB928 150 mg orally once daily on Days 1 to 28 of each 28 day cycle; 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.
Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab	Experimental	Drug: Nab-Paclitaxel, Drug: Gemcitabine, Drug: Atezolizumab, Drug: TiragolumabCohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Tiragolumab 420 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.
Cohort 2: Atezolizumab + Cobimetinib	Experimental	Drug: Atezolizumab, Drug: CobimetinibCohort 2: Participants will receive Cobimetinib 60 milligrams (mg) once daily orally on Days 1-21 of each 28-day cycle; and Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arm is open for enrollment.
Cohort 2: Atezolizumab + PEGPH20	Experimental	Drug: Atezolizumab, Drug: PEGPH20Cohort 2: Participants will receive PEGPH20 3 micrograms per kilogram (mcg/kg) IV infusion on Days 1, 8 and 15 of each 21-day cycle; and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
Cohort 2: Atezolizumab + BL-8040	Experimental	Drug: Atezolizumab, Drug: BL-8040Cohort 2: Participants will receive BL-8040 1.25 milligrams per kilogram (mg/kg) subcutaneously (SC) on Days 1-5 of the first week, followed by combination treatment consisting of BL-8040 1.25 mg/kg SC three times a week on non-consecutive days and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
Cohort 2: Atezolizumab + RO6874281 every 2 weeks	Experimental	Drug: Atezolizumab, Drug: RO6874281Cohort 2: Participants will receive Atezolizumab 840 mg IV infusion on days 1 and 15 of each 28 day cycle; RO6874281 will be administered 10 mg by IV infusion on day 1 and 15 mg on days 8, 15, and 22 for cycle 1 (28 day cycle). RO6874281 will be administered 15 mg by IV infusion on days 1 and 15 of each subsequent 28 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
Cohort 2: Atezolizumab + RO6874281 every 3 weeks	Experimental	Drug: Atezolizumab, Drug: RO6874281Cohort 2: Participants will receive Atezolizumab 1200 mg IV infusion on Day 1 of each 21 day cycle; and RO6874281 10 mg by IV infusion on day 1 of each 21 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)	Active comparator	Drug: Nab-Paclitaxel, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Leucovorin, Drug: FluorouracilCohort 2: Participants who progressed on a prior fluoropyrimidine-based regimen 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 who progressed on a prior gemcitabine-based regimen will receive 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6). Participants will receive Oxaliplatin 85 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Leucovorin 400 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Fluorouracil 400 mg/m^2 IV push on Days 1 and 15 of each 28 day cycle; and Fluorouracil 2400 mg/m^2 IV continuous infusion over 46 hours on Days 1 and 2 and on Days 15 and 16 of each 28 day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab	Experimental	Drug: Nab-Paclitaxel, Drug: Gemcitabine, Drug: Atezolizumab, Drug: TocilizumabCohort 1: Participants will receive Tocilizumab 8 mg/kg IV infusion on Day 1 of each 28 day cycle; Atezolizumab 1680 mg IV infusion on Day 1 of each 28 day cycle; 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nab-PaclitaxelNab-Paclitaxel will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + AB928, Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab, Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab, Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab, Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab, Cohort 1: Control (Nab-Paclitaxel and Gemcitabine), Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
GemcitabineGemcitabine will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + AB928, Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab, Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab, Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab, Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab, Cohort 1: Control (Nab-Paclitaxel and Gemcitabine), Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
OxaliplatinOxaliplatin will be administered as per the schedule specified in the respective arm.	Drug	Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
LeucovorinLeucovorin will be administered as per the schedule specified in the respective arm.	Drug	Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
FluorouracilFluorouracil will be administered as per the schedule specified in the respective arm.	Drug	Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
AtezolizumabAtezolizumab will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + AB928, Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab, Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab, Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab, Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab, Cohort 2: Atezolizumab + BL-8040, Cohort 2: Atezolizumab + Cobimetinib, Cohort 2: Atezolizumab + PEGPH20, Cohort 2: Atezolizumab + RO6874281 every 2 weeks, Cohort 2: Atezolizumab + RO6874281 every 3 weeks
CobimetinibCobimetinib will be administered as per the schedule specified in the respective arm.	Drug	Cohort 2: Atezolizumab + Cobimetinib
PEGPH20PEGPH20 will be administered as per the schedule specified in the respective arm.	Drug	Cohort 2: Atezolizumab + PEGPH20
BL-8040BL-8040 will be administered as per the schedule specified in the respective arm.	Drug	Cohort 2: Atezolizumab + BL-8040
SelicrelumabSelicrelumab will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
BevacizumabBevacizumab will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
RO6874281RO6874281 will be administered as per the schedule specified in the respective arm	Drug	Cohort 2: Atezolizumab + RO6874281 every 2 weeks, Cohort 2: Atezolizumab + RO6874281 every 3 weeks
AB928AB928 will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + AB928
TiragolumabTiragolumab will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
TocilizumabTocilizumab will be administered as per the schedule specified in the respective arm.	Drug	Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab

Primary outcome

Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to 33.3 months
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.

6 secondary outcomes

Number of Participants With Adverse Events (AEs)
Time frame: Up to 33.3 months
Stage 1: Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1
Time frame: Up to 33.3 months
Stage 1: Overall Survival (OS), as Determined by Investigator According to RECIST v1.1
Time frame: Up to 33.3 months
Stage 1: OS Rate at Month 6
Time frame: Month 6
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1
Time frame: Up to 33.3 months
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1
Time frame: Up to 33.3 months

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)	35	0
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab	9	0
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab	25	0
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928	16	0
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab	42	0
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab	31	0
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])	25	0
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)	25	0
Stage 1 Cohort 2: Atezolizumab + BL-8040	16	0
Stage 1 Cohort 2: Atezolizumab + Cobimetinib	15	0
Stage 1 Cohort 2: Atezolizumab + PEGPH20	71	0
Stage 1 Cohort 2: Atezolizumab + RO6874281 Every 3 Weeks (Q3W)	16	0
Stage 1 Cohort 2: Atezolizumab + RO6874281 Every 2 Weeks (Q2W)	15	0
Stage 2 Cohort 2: Atezolizumab + Cobimetinib	0	0
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W	0	0
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W	0	0

Primary outcome: Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: Up to 33.3 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) n = 32	Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab n = 9	Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab n = 25	Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928 n = 15	Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab n = 41	Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab n = 30	Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6]) n = 23	Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine) n = 23	Stage 1 Cohort 2: Atezolizumab + BL-8040 n = 14	Stage 1 Cohort 2: Atezolizumab + Cobimetinib n = 14	Stage 1 Cohort 2: Atezolizumab + PEGPH20 n = 66	Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W n = 15	Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W n = 14
Value	37.5 (21.10 to 56.31)	55.6 (21.20 to 86.30)	48.0 (27.80 to 68.69)	26.7 (7.79 to 55.10)	31.7 (18.08 to 48.09)	30.0 (14.73 to 49.40)	8.7 (1.07 to 28.04)	0 (0.00 to 14.82)	0 (0.00 to 23.16)	0 (0.00 to 23.16)	6.1 (1.68 to 14.80)	0 (0.00 to 21.80)	7.1 (0.18 to 33.87)

Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) vs Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab: Difference in ORR: 18.06 (95% CI -25.60 to 61.71)
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) vs Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab: Difference in ORR: 10.50 (95% CI -18.85 to 39.85)
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) vs Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928: Difference in ORR: -10.83 (95% CI -43.70 to 22.03)

Population analysed: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 33.3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)	13 of 32 (40.6%)	32 of 32 (100%)	23 of 32
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab	8 of 9 (88.9%)	9 of 9 (100%)	8 of 9
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab	17 of 25 (68%)	23 of 25 (92%)	23 of 25
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928	4 of 15 (26.7%)	15 of 15 (100%)	14 of 15
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab	19 of 41 (46.3%)	40 of 41 (97.6%)	34 of 41
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab	12 of 30 (40%)	30 of 30 (100%)	28 of 30
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])	10 of 23 (43.5%)	21 of 23 (91.3%)	19 of 23
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)	12 of 23 (52.2%)	23 of 23 (100%)	21 of 23
Stage 1 Cohort 2: Atezolizumab + BL-8040	4 of 15 (26.7%)	15 of 15 (100%)	14 of 15
Stage 1 Cohort 2: Atezolizumab + Cobimetinib	8 of 14 (57.1%)	13 of 14 (92.9%)	11 of 14
Stage 1 Cohort 2: Atezolizumab + PEGPH20	30 of 66 (45.5%)	65 of 66 (98.5%)	60 of 66
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W	7 of 15 (46.7%)	15 of 15 (100%)	14 of 15
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W	2 of 14 (14.3%)	14 of 14 (100%)	14 of 14
Stage 2 Cohort 2: Atezolizumab + Cobimetinib	7 of 14 (50%)	13 of 14 (92.9%)	14 of 14
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W	2 of 6 (33.3%)	6 of 6 (100%)	5 of 6
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W	0 of 1 (0%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39707623Ko 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.
Derived from this study: PubMed 36940261Ko 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

23 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nab-Paclitaxel, Gemcitabine and Oxaliplatin in people with Pancreatic Adenocarcinoma, run by Hoffmann-La Roche at 23 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Spain, Japan, South Korea, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Up to 33.3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03193190, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.