Trial · NCT03193190
A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
NCT03193190, Phase 1, Phase 2, Completed, Hoffmann-La Roche; results first posted 2025-11-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer). Trials, record NCT03193190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03193190
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
- NCT number
- NCT03193190
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 341 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Pancreatic Adenocarcinoma
- Interventions
- Nab-Paclitaxel, Gemcitabine, Oxaliplatin, Leucovorin, Fluorouracil, Atezolizumab, Cobimetinib, PEGPH20, BL-8040, Selicrelumab, Bevacizumab, RO6874281, AB928, Tiragolumab, Tocilizumab
- First posted
- 2017-06-20
- Last updated
- 2025-11-21
- Other registries' IDs
- eudract:2016-004126-42
- Results first posted
- 2025-11-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to 33.3 months | 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. |
| Secondary | Stage 1: Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | 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. |
| Secondary | Stage 1: Overall Survival (OS), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS. |
| Secondary | Stage 1: OS Rate at Month 6 | 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. |
| Secondary | Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | 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. |
| Secondary | Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Up to 33.3 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to 33.3 months | Safety population included all participants who received any amount of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Stage 1: Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | 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. | months | MEDIAN |
| SECONDARY | Stage 1: Overall Survival (OS), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | 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. | months | MEDIAN |
| SECONDARY | Stage 1: OS Rate at Month 6 | Month 6 | 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. | percentage of participants | NUMBER |
| SECONDARY | Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | 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. Overall number analyzed included participants with OR i.e responders. | months | MEDIAN |
| SECONDARY | Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1 | Up to 33.3 months | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) | 37.5 | 95% Confidence Interval 21.10 to 56.31 | percentage of participants | |
| 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) | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab | 55.6 | 95% Confidence Interval 21.20 to 86.30 | percentage of participants | |
| 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) | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab | 48.0 | 95% Confidence Interval 27.80 to 68.69 | percentage of participants | |
| 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) | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928 | 26.7 | 95% Confidence Interval 7.79 to 55.10 | percentage of participants | |
| 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) | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab | 31.7 | 95% Confidence Interval 18.08 to 48.09 | percentage of participants | |
| 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) | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab | 30.0 | 95% Confidence Interval 14.73 to 49.40 | percentage of participants | |
| 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) | Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6]) | 8.7 | 95% Confidence Interval 1.07 to 28.04 | percentage of participants | |
| 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) | Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine) | 0 | 95% Confidence Interval 0.00 to 14.82 | percentage of participants | |
| 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) | Stage 1 Cohort 2: Atezolizumab + BL-8040 | 0 | 95% Confidence Interval 0.00 to 23.16 | percentage of participants | |
| 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) | Stage 1 Cohort 2: Atezolizumab + Cobimetinib | 0 | 95% Confidence Interval 0.00 to 23.16 | percentage of participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow128
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 1 | STARTED | Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) | 35 | |
| Stage 1 | STARTED | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab | 9 | |
| Stage 1 | STARTED | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab | 25 | |
| Stage 1 | STARTED | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928 | 16 | |
| Stage 1 | STARTED | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab | 42 | |
| Stage 1 | STARTED | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab | 31 | |
| Stage 1 | STARTED | Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6]) | 25 | |
| Stage 1 | STARTED | Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine) | 25 | |
| Stage 1 | STARTED | Stage 1 Cohort 2: Atezolizumab + BL-8040 | 16 | |
| Stage 1 | STARTED | Stage 1 Cohort 2: Atezolizumab + Cobimetinib | 15 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 participant flowAdverse events6,528
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) | 14 | 32 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab | 4 | 9 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab | 10 | 25 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928 | 9 | 15 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab | 13 | 41 | 19 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab | 6 | 30 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6]) | 4 | 23 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine) | 6 | 23 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 2: Atezolizumab + BL-8040 | 3 | 15 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 Cohort 2: Atezolizumab + Cobimetinib | 2 | 14 | 2 |
1 to 10 of 6,528Source ClinicalTrials.gov
See all 6,528 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine) | 23 | 32 |
| Total, all-cause mortality | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab | 8 | 9 |
| Total, all-cause mortality | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab | 23 | 25 |
| Total, all-cause mortality | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928 | 14 | 15 |
| Total, all-cause mortality | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab | 34 | 41 |
| Total, all-cause mortality | Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab | 28 | 30 |
| Total, all-cause mortality | Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6]) | 19 | 23 |
| Total, all-cause mortality | Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine) | 21 | 23 |
| Total, all-cause mortality | Stage 1 Cohort 2: Atezolizumab + BL-8040 | 14 | 15 |
| Total, all-cause mortality | Stage 1 Cohort 2: Atezolizumab + Cobimetinib | 11 | 14 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03193190
GET https://conductscience.org/api/trials/v1/NCT03193190/results?page=2