Trial · NCT04696055
Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors
NCT04696055, Phase 2, Completed, Bayer; results first posted 2023-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors. Trials, record NCT04696055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04696055
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors
- NCT number
- NCT04696055
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 95 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Pembrolizumab, Regorafenib (Stivarga, BAY73-4506)
- First posted
- 2021-01-06
- Last updated
- 2025-05-13
- Other registries' IDs
- eudract:2020-003555-16
- Results first posted
- 2023-05-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment | Up to 15 months. Data up to 38 months are now available and are also reported for full transparency. | Overall response rate (ORR) is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR). ORR per RECIST 1.1 by independent central assessment is reported). RECIST 1.1: response evaluation criteria in solid tumors version 1.1 |
| Secondary | Overall Response Rate (ORR) Per RECIST 1.1 by Investigator Assessment | Up to 38 months | Overall response rate (ORR) is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR). ORR by RECIST 1.1 investigator review is reported. RECIST 1.1: response evaluation criteria in solid tumors version 1.1 |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment | Up to 38 months | Duration of response (DOR) for partial response (PR) and complete response (CR) was defined as the time from the first documented objective response of PR or CR, whichever noted earlier, to disease progression or death (if death occurs before progression was documented). DOR was defined for confirmed responders only, i.e., participants with a CR or PR. RECIST 1.1: response evaluation criteria in solid tumors version 1.1 |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 38 months | An AE was considered as treatment-emergent (TEAE) if arising or worsening after start of first study intervention administration until 30 days after administration of any study intervention. In addition, any AEs qualifying as a serious adverse event (SAE) were collected for 90 days after the last dose of pembrolizumab, unless a new anti-cancer therapy had been initiated. |
| Secondary | Number of Participants With Safety-relevant Changes in Clinical Parameters | Up to 38 months | Number of participants with clinically relevant trends observed in laboratory data, ECG data, or ECOG performance status is reported. |
| Secondary | Percentage of Participants With Dose Modification | Up to 38 months | Dose modification included dose interruption, dose reduction, dose discontinuation. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment | Up to 15 months. Data up to 38 months are now available and are also reported for full transparency. | Full Analysis Set (FAS) | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) Per RECIST 1.1 by Investigator Assessment | Up to 38 months | Full Analysis Set (FAS) | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment | Up to 38 months | Confirmed responders in Full Analysis Set (FAS) | Days | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 38 months | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Safety-relevant Changes in Clinical Parameters | Up to 38 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Participants With Dose Modification | Up to 38 months | Full Analysis Set (FAS) | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | Up to 15 months (primary outcome as previously reported) | 5.9 | 95% Confidence Interval 1.6 to 14.4 | Percentage of participants |
| Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | Up to 15 months (primary outcome as previously reported) | 11.1 | 95% Confidence Interval 2.4 to 29.2 | Percentage of participants |
| Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | Up to 38 months (as of study completion) | 7.4 | 95% Confidence Interval 2.4 to 16.3 | Percentage of participants |
| Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | Up to 38 months (as of study completion) | 14.8 | 95% Confidence Interval 4.2 to 33.7 | Percentage of participants |
| Overall Response Rate (ORR) Per RECIST 1.1 by Investigator Assessment | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | 7.4 | 95% Confidence Interval 2.4 to 16.3 | Percentage of participants | |
| Overall Response Rate (ORR) Per RECIST 1.1 by Investigator Assessment | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | 18.5 | 95% Confidence Interval 6.3 to 38.1 | Percentage of participants | |
| Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | Central assessment | 210 | Full Range 158 to 937 | Days |
| Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | Central assessment | 195 | Full Range 83 to 280 | Days |
| Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | Investigator assessment | 431 | Full Range 82 to 893 | Days |
| Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | Investigator assessment | 364 | Full Range 117 to 839 | Days |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | 68 | |
| Overall Study | STARTED | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | 27 | |
| Overall Study | COMPLETED | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | 0 | |
| Overall Study | COMPLETED | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | 68 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | 27 |
Source ClinicalTrials.gov
Adverse events228
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+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 11 | 68 | 22 |
| other | Anaemia | Blood and lymphatic system disorders | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 2 | 27 | 12 |
| other | Hypothyroidism | Endocrine disorders | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 5 | 68 | 5 |
| other | Hypothyroidism | Endocrine disorders | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 0 | 27 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 15 | 68 | 17 |
| other | Abdominal pain | Gastrointestinal disorders | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 5 | 27 | 9 |
| other | Abdominal pain upper | Gastrointestinal disorders | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 4 | 68 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 4 | 27 | 6 |
| other | Ascites | Gastrointestinal disorders | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 5 | 68 | 9 |
| other | Ascites | Gastrointestinal disorders | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 3 | 27 | 3 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 53 | 68 |
| Total, all-cause mortality | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 20 | 27 |
| Total, other adverse events | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 63 | 68 |
| Total, other adverse events | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 27 | 27 |
| Total, serious adverse events | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | 37 | 68 |
| Total, serious adverse events | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 11 | 27 |
Source ClinicalTrials.gov
Papers0
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) vs Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]): Number of Participants With Safety-relevant Changes in Clinical Parameters | Trial comparisons |
| Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] vs Regorafenib+Pembrolizumab [Any Other IO Containing Treatment]: deaths from any cause | Trial comparisons |
| Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] vs Regorafenib+Pembrolizumab [Any Other IO Containing Treatment]: serious adverse events | Trial comparisons |
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/NCT04696055
GET https://conductscience.org/api/trials/v1/NCT04696055/results?page=2