Trial · NCT03555149
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
NCT03555149, Phase 1, Phase 2, Terminated, Hoffmann-La Roche; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC). Trials, record NCT03555149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03555149
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
- NCT number
- NCT03555149
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Colorectal Cancer
- Interventions
- Regorafenib, Atezolizumab, Imprime PGG, Bevacizumab, Isatuximab, Selicrelumab, Idasanutlin, AB928, LOAd703
- First posted
- 2018-06-13
- Last updated
- 2023-11-07
- Other registries' IDs
- eudract:2017-004566-99
- Results first posted
- 2023-11-07
- Limitations and caveats
This study is not designed to make explicit power and Type I error considerations for a hypothesis test. Instead, this study is designed to obtain preliminary efficacy, safety, and PK data. No formal statistical hypothesis testing was performed in this study. Due to the limited sample size, the results need to be interpreted with caution. For the Atezo+Idasa and Atezo+LOAd703 groups, no meaningful conclusion could be drawn because these experimental arms have been terminated prematurely.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | From randomization until disease progression or loss of clinical benefit (up to 4 years) | The best confirmed overall response rate (ORR) is defined as the percentage of participants with a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1. Participants could be classified as "Stable Disease" if the assessment was at least 6 weeks from randomization. Participants were classified as Missing if no post-baseline response assessments were available. Participants were classified as Not Evaluable if all post-baseline response assessments were unevaluable. The differences in ORR between the experimental arms and the corresponding control arm were calculated, along with 95% confidence intervals (CIs), using normal approximation of the binomial distribution. The 95% CIs for ORRs were constructed using the Clopper-Pearson method. The 95% CIs for the difference in rates were constructed using the Wald method with continuity correction. |
| Secondary | Progression-Free Survival (PFS) as Determined by Investigator According to RECIST v1.1 | From randomization up to the first occurrence of disease or death from any cause (up to 4 years) | Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), was determined by the investigator according to RECIST v1.1. For participants who did not have documented disease progression or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method. |
| Secondary | Overall Survival (OS) | From randomization up to death from any cause (up to 4 years) | Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier method was used to estimate the median for OS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method. |
| Secondary | Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS) | 3, 6, 12, and 18 months | Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. OS is shown as the percentage of participants who were event-free at the landmark timepoints of 3, 6, 12, and 18 months. |
| Secondary | Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 | From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 4 years) | Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause. |
| Secondary | Disease Control Rate (DCR), as Determined by the Investigator Per RECIST v1.1 | From randomization until disease progression or loss of clinical benefit (up to 4 years) | Disease control rate is defined as the percentage of participants with stable disease for ≥12 weeks or a complete or partial response, as determined by the investigator according to RECIST v1.1. |
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) | Adverse event data were collected from baseline up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from baseline through survival follow-up (up to 4 years) | The incidence, nature, and severity of adverse events (AEs) are reported, with severity determined according to NCI CTCAE v4.0. All AEs were reported until 30 days after the last study dose or until start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest were reported until 135 days (or 180 days for the Atezolizumab + LOAd703 arm only) after the last dose of study treatment. |
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 | Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | From randomization until disease progression or loss of clinical benefit (up to 4 years) | The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen. | Percentage of Participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) as Determined by Investigator According to RECIST v1.1 | From randomization up to the first occurrence of disease or death from any cause (up to 4 years) | The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to death from any cause (up to 4 years) | The efficacy evaluable population included all participants who received at least one dose of each study drug for their assigned treatment regimen. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS) | 3, 6, 12, and 18 months | The efficacy evaluable population included all participants who received at least one dose of each study drug for their assigned treatment regimen. The number analyzed at each landmark timepoint indicates the number of participants who were remaining at risk for an event. The event-free rate was not estimable (NE) for landmark timepoints at which 0 participants were remaining at risk for an an event. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 | From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 4 years) | The duration of response analysis included all participants from the efficacy evaluable population who had a confirmed overall response; only 1 participant in each of the atezolizumab + regorafenib arm and the atezolizumab + regorafenib + AB928 arm had a confirmed response. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR), as Determined by the Investigator Per RECIST v1.1 | From randomization until disease progression or loss of clinical benefit (up to 4 years) | The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Adverse Event (AE) | Adverse event data were collected from baseline up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from baseline through survival follow-up (up to 4 years) | The safety-evaluable population included all patients who received any amount of dose of any component of study treatment. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group247
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Regorafenib (Control) | Responders (CR + PR) | 0 | 95% Confidence Interval 0 to 17.65 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + Imprime PGG + Bevacizumab | Responders (CR + PR) | 0 | 95% Confidence Interval 0 to 21.80 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + Isatuximab | Responders (CR + PR) | 0 | 95% Confidence Interval 0 to 21.80 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + Selicrelumab + Bevacizumab | Responders (CR + PR) | 0 | 95% Confidence Interval 0 to 45.93 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + Idasanutlin | Responders (CR + PR) | 0 | 95% Confidence Interval 0 to 60.24 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + Regorafenib | Responders (CR + PR) | 6.7 | 95% Confidence Interval 0.17 to 31.95 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + Regorafenib + AB928 | Responders (CR + PR) | 6.7 | 95% Confidence Interval 0.17 to 31.95 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + LOAd703 | Responders (CR + PR) | 0 | 95% Confidence Interval 0 to 84.19 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Regorafenib (Control) | Complete Response (CR) | 0 | 95% Confidence Interval 0 to 17.65 | Percentage of Participants |
| Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Atezolizumab + Imprime PGG + Bevacizumab | Complete Response (CR) | 0 | 95% Confidence Interval 0 to 21.80 | Percentage of Participants |
1 to 10 of 247Source ClinicalTrials.gov
See all 247 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regorafenib (Control) | 24 | |
| Overall Study | STARTED | Atezolizumab + Imprime PGG + Bevacizumab | 15 | |
| Overall Study | STARTED | Atezolizumab + Isatuximab | 15 | |
| Overall Study | STARTED | Atezolizumab + Selicrelumab + Bevacizumab | 6 | |
| Overall Study | STARTED | Atezolizumab + Idasanutlin | 4 | |
| Overall Study | STARTED | Atezolizumab + Regorafenib | 15 | |
| Overall Study | STARTED | Atezolizumab + Regorafenib + AB928 | 15 | |
| Overall Study | STARTED | Atezolizumab + LOAd703 | 2 | |
| Overall Study | Received at Least One Dose of Study Treatment | Regorafenib (Control) | 19 | |
| Overall Study | Received at Least One Dose of Study Treatment | Atezolizumab + Imprime PGG + Bevacizumab | 15 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events1,888
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 | Regorafenib (Control) | 2 | 19 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + Imprime PGG + Bevacizumab | 1 | 15 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + Isatuximab | 3 | 15 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + Selicrelumab + Bevacizumab | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + Idasanutlin | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + Regorafenib | 3 | 15 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + Regorafenib + AB928 | 3 | 15 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab + LOAd703 | 0 | 2 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Regorafenib (Control) | 0 | 19 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Atezolizumab + Imprime PGG + Bevacizumab | 0 | 15 | 0 |
1 to 10 of 1,888Source ClinicalTrials.gov
See all 1,888 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib (Control) | 18 | 24 |
| Total, all-cause mortality | Atezolizumab + Imprime PGG + Bevacizumab | 15 | 15 |
| Total, all-cause mortality | Atezolizumab + Isatuximab | 15 | 15 |
| Total, all-cause mortality | Atezolizumab + Selicrelumab + Bevacizumab | 4 | 6 |
| Total, all-cause mortality | Atezolizumab + Idasanutlin | 4 | 4 |
| Total, all-cause mortality | Atezolizumab + Regorafenib | 11 | 15 |
| Total, all-cause mortality | Atezolizumab + Regorafenib + AB928 | 12 | 15 |
| Total, all-cause mortality | Atezolizumab + LOAd703 | 1 | 2 |
| Total, other adverse events | Regorafenib (Control) | 19 | 19 |
| Total, other adverse events | Atezolizumab + Imprime PGG + Bevacizumab | 15 | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03555149
GET https://conductscience.org/api/trials/v1/NCT03555149/results?page=2