Trial · NCT04126733
Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)
NCT04126733, Phase 2, Completed, Bayer; results first posted 2021-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable). Trials, record NCT04126733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04126733
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)
- NCT number
- NCT04126733
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Colorectal Cancer
- Interventions
- Regorafenib (Stivarga, BAY73-4506), Nivolumab (Opdivo)
- First posted
- 2019-10-15
- Last updated
- 2023-07-18
- Results first posted
- 2021-12-14
- Limitations and caveats
- Preliminary efficacy assessment suggested that the study would not meet its primary efficacy endpoint, therefore the study was stopped.
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 Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 Assessed by Investigator | Through database cut-off date of 11-NOV-2020 (Primary Completion Date) (up to 13 months) | ORR was defined as the percentage of participants with overall response of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. |
| Secondary | Duration of Response (DOR) | Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months) | DOR was defined for responders only as the time from first documentation of response (i.e. CR or PR) until disease progression or death (if death without documented disease progression). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. |
| Secondary | Disease Control Rate (DCR) at 8 and 16 Weeks | At 8, 16, 24, 32 and 40 weeks | DCR was defined as the percentage of participants with tumor response of complete response (CR), partial response (PR) or stable disease (SD). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. |
| Secondary | Progression-free Survival (PFS) | Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months) | PFS was the time from first dose of study medication to disease progression or death, whichever was earlier. |
| Secondary | Overall Survival (OS) | Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months) | OS was defined as time from first dose of the study treatment to death. For patients who did not die, OS was censored at the last time point at which the survival status was known to be alive. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Different Severity Types of TEAEs Per Common Terminology Criteria for Adverse Events (CTCAE) v5 | 30 days after last dose of regorafenib and 100 days after last dose of nivolumab until study completion (up to 30 months) | TEAEs were started during treatment or within the post-treatment time window (30 days after last dose of regorafenib and 100 days after last dose of nivolumab.). TEAEs were summarized by system organ class (SOC) and preferred term, severity (based on CTCAE v5 grades). Laboratory data considered as AE were graded according to CTCAE v5. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. |
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 | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 Assessed by Investigator | Through database cut-off date of 11-NOV-2020 (Primary Completion Date) (up to 13 months) | Full Analysis Set (FAS) | percentage (%) of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months) | Full Analysis Set (FAS) | weeks | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) at 8 and 16 Weeks | At 8, 16, 24, 32 and 40 weeks | Full Analysis Set (FAS) | percentage (%) of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months) | Full Analysis Set (FAS) | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months) | Full Analysis Set (FAS) | weeks | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Different Severity Types of TEAEs Per Common Terminology Criteria for Adverse Events (CTCAE) v5 | 30 days after last dose of regorafenib and 100 days after last dose of nivolumab until study completion (up to 30 months) | Full Analysis Set (FAS) | participants | NUMBER |
| POST_HOC | Duration of Stable Disease | Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months) | Full Analysis Set (FAS) | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group22
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 Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 Assessed by Investigator | Regorafenib Plus Nivolumab | 7.1 | 95% Confidence Interval 2.4 to 15.9 | percentage (%) of participants | |
| Duration of Response (DOR) | Regorafenib Plus Nivolumab | NA | 95% Confidence Interval 16.14 to NA | weeks | |
| Disease Control Rate (DCR) at 8 and 16 Weeks | Regorafenib Plus Nivolumab | Disease Control Rate at 8 weeks | 38.6 | 95% Confidence Interval 27.2 to 51.0 | percentage (%) of participants |
| Disease Control Rate (DCR) at 8 and 16 Weeks | Regorafenib Plus Nivolumab | Disease Control Rate at 16 weeks | 38.6 | 95% Confidence Interval 27.2 to 51.0 | percentage (%) of participants |
| Disease Control Rate (DCR) at 8 and 16 Weeks | Regorafenib Plus Nivolumab | Disease Control Rate at 24 weeks | 38.6 | 95% Confidence Interval 27.2 to 51.0 | percentage (%) of participants |
| Disease Control Rate (DCR) at 8 and 16 Weeks | Regorafenib Plus Nivolumab | Disease Control Rate at 32 weeks | 38.6 | 95% Confidence Interval 27.2 to 51.0 | percentage (%) of participants |
| Disease Control Rate (DCR) at 8 and 16 Weeks | Regorafenib Plus Nivolumab | Disease Control Rate at 40 weeks | 38.6 | 95% Confidence Interval 27.2 to 51.0 | percentage (%) of participants |
| Progression-free Survival (PFS) | Regorafenib Plus Nivolumab | 8.00 | 95% Confidence Interval 7.86 to 10.57 | weeks | |
| Overall Survival (OS) | Regorafenib Plus Nivolumab | 51.86 | 95% Confidence Interval 30.29 to 69.71 | weeks | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Different Severity Types of TEAEs Per Common Terminology Criteria for Adverse Events (CTCAE) v5 | Regorafenib Plus Nivolumab | Any AEs | 69 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Regorafenib Plus Nivolumab | 70 | |
| Treatment Period | COMPLETED | Regorafenib Plus Nivolumab | 0 | |
| Treatment Period | NOT COMPLETED | Regorafenib Plus Nivolumab | 70 | |
| Active Follow-up Period | STARTED | Regorafenib Plus Nivolumab | 39 | |
| Active Follow-up Period | COMPLETED | Regorafenib Plus Nivolumab | 19 | |
| Active Follow-up Period | NOT COMPLETED | Regorafenib Plus Nivolumab | 20 | |
| Long-term Follow-up Period | STARTED | Regorafenib Plus Nivolumab | 29 | |
| Long-term Follow-up Period | COMPLETED | Regorafenib Plus Nivolumab | 0 | |
| Long-term Follow-up Period | NOT COMPLETED | Regorafenib Plus Nivolumab | 29 |
Source ClinicalTrials.gov
Adverse events297
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 Plus Nivolumab | 13 | 70 | 24 |
| other | Hypothyroidism | Endocrine disorders | Regorafenib Plus Nivolumab | 6 | 70 | 6 |
| other | Abdominal distension | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 5 | 70 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 15 | 70 | 18 |
| other | Abdominal pain upper | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 7 | 70 | 9 |
| other | Constipation | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 11 | 70 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 14 | 70 | 18 |
| other | Dry mouth | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 7 | 70 | 7 |
| other | Nausea | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 16 | 70 | 18 |
| other | Stomatitis | Gastrointestinal disorders | Regorafenib Plus Nivolumab | 11 | 70 | 13 |
1 to 10 of 297Source ClinicalTrials.gov
See all 297 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib Plus Nivolumab | 40 | 70 |
| Total, other adverse events | Regorafenib Plus Nivolumab | 66 | 70 |
| Total, serious adverse events | Regorafenib Plus Nivolumab | 34 | 70 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37090438 | DERIVED |
Source PubMed
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.
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