Trial · NCT03406871
Regorafenib and Nivolumab Simultaneous Combination Therapy
NCT03406871, Phase 1, Completed, Kohei Shitara; results first posted 2025-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Regorafenib and Nivolumab Simultaneous Combination Therapy. Trials, record NCT03406871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03406871
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib and Nivolumab Simultaneous Combination Therapy
- NCT number
- NCT03406871
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- Kohei Shitara
- Conditions
- Advanced and Metastatic Solid Tumor
- Interventions
- Regorafenib, Nivolumab
- First posted
- 2018-01-23
- Last updated
- 2025-01-24
- Results first posted
- 2025-01-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Dose Limiting Toxicity (DLT) for RD Determination | 4 weeks | The procedure for DLT assessment was as follows: 1. When DLT is observed in 1 out of 3 cases, 3 additional cases are added to the administration level. 2. When DLT is observed in more than 2 of 3 cases, it is judged that the administration level exceeds Maximum Tolerated Dose (MTD). 3. If the number of DLT is 1 case or less in 6 cases, shift to the next level. 4. If MTD is exceeded, shift to the next lower level. At the relevant dose, if only 3 people are evaluating DLT, add 3 cases. When the number of DLT is 1 or less out of 6, the dose is defined as MTD and RD. If it is judged that Level 1 exceeds the MTD, review the dose or consider stopping the trial. 5. MTD should be the highest dose level of DLT expression less than 1 in 6 cases. - After the RD was determined and the patient moved to the expansion cohort, G3 skin toxicity occurred, so based on the recommendation of the Data and Safety Monitoring Committee, the RD was reduced by one level and the trial was resumed. |
| Secondary | Objective Response Rate (ORR) | 2year | \*Objective Response Rate is defined as the proportion of patients whose best overall response, as per the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 and immune-related RECIST (irRECIST), is either Complete Response (CR) or Partial Response (PR). |
| Secondary | Progression-Free Survival(PFS) | 6 months | \*PFS is defined as the time from the enrollment date to either the date when disease progression is determined or the date of death from any cause, whichever came earlier. The data were compiled according to the analysis plan outlined in the protocol. No analysis was conducted to determine efficacy by cancer type or dose level. |
| Secondary | Overall Survival(OS) | 2year | \*OS is defined as the period from the date of enrollment to the date of death from any cause. Surviving patients are censored on the last confirmation date of survival (confirmation of survival by telephone is permitted; the fact that survival is confirmed is to be recorded in the medical record, etc.). Patients lost to follow-up are censored on the last date on which their survival is confirmed before being lost to follow-up. The data were compiled according to the analysis plan outlined in the protocol. No analysis was conducted to determine efficacy by cancer type or dose level. |
| Secondary | Disease Control Rate(DCR) | 2year | \*DCR is defined as the proportion of patients whose best overall response assessed based on the RECIST guideline version 1.1 and irRECIST is any of CR, PR, or Stable Disease (SD). The data were compiled according to the analysis plan outlined in the protocol. No analysis was conducted to determine efficacy by cancer type or dose level. |
| Secondary | Adverse-Events | 2 year | * The occurrences rate of each AE of the worst grade occurring in this study was evaluated based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 throughout the entire cycles will be calculated. Additionally, this study included a special note regarding abnormal laboratory values. If clinical signs and symptoms observed in this study were induced, the diagnosis and associated data were collected based on whether or not they were due to abnormal laboratory values. Therefore, for example, results of grading regarding liver dysfunction may differ between non-hematologic toxicity and laboratory values. * Adverse-Events occurrences means "prevalence proportion" of any undesirable occurrence based on investigator's medical decision in this study. |
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 | The Number of Dose Limiting Toxicity (DLT) for RD Determination | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate (ORR) | 2year | The primary objective of this study was to evaluate the RD on the basis of the safety of the combination of nivolumab and regorafenib, and the clinical trial was intended to evaluate the efficacy of this therapy secondarily. Therefore, dose-specific efficacy analyses were not preplanned or considered to evaluate this outcome measure. Ultimately, the trial was intended to provide an overall efficacy in this study. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival(PFS) | 6 months | The primary objective of this study was to evaluate the RD on the basis of the safety of the combination of nivolumab and regorafenib, and the clinical trial was intended to evaluate the efficacy of this therapy secondarily. Therefore, dose-specific efficacy analyses were not preplanned or considered to evaluate this outcome measure. Ultimately, the trial was intended to provide an overall efficacy in this study. | months | MEDIAN |
| SECONDARY | Overall Survival(OS) | 2year | The primary objective of this study was to evaluate the RD on the basis of the safety of the combination of nivolumab and regorafenib, and the clinical trial was intended to evaluate the efficacy of this therapy secondarily. Therefore, dose-specific efficacy analyses were not preplanned or considered to evaluate this outcome measure. Ultimately, the trial was intended to provide an overall efficacy in this study. | median of months | MEDIAN |
| SECONDARY | Disease Control Rate(DCR) | 2year | The primary objective of this study was to evaluate the RD on the basis of the safety of the combination of nivolumab and regorafenib, and the clinical trial was intended to evaluate the efficacy of this therapy secondarily. Therefore, dose-specific efficacy analyses were not preplanned or considered to evaluate this outcome measure. Ultimately, the trial was intended to provide an overall efficacy in this study. | percentage of participants | NUMBER |
| SECONDARY | Adverse-Events | 2 year | This protocol specifies that secondary endpoint were not analysed separately for colorectal cancer and gastric cancer, and cases both the dose escalation cohort and the expansion cohort were included. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Dose Limiting Toxicity (DLT) for RD Determination | Dose Escalation Cohort Regorafenib 80mg | 0 | Participants | ||
| The Number of Dose Limiting Toxicity (DLT) for RD Determination | Dose Escalation Cohort Regorafenib 120mg | 0 | Participants | ||
| The Number of Dose Limiting Toxicity (DLT) for RD Determination | Dose Escalation Cohort Regorafenib 160mg | 3 | Participants | ||
| The Number of Dose Limiting Toxicity (DLT) for RD Determination | Expansion Cohort : Regorafenib 120mg | 5 | Participants | ||
| Objective Response Rate (ORR) | Final Analysis | 42.0 | 95% Confidence Interval 28.2 to 56.8 | percentage of participants | |
| Progression-Free Survival(PFS) | Final Analysis | 6.3 | 95% Confidence Interval 3.9 to 10.4 | months | |
| Overall Survival(OS) | Final Analysis | 14.4 | 95% Confidence Interval 9.8 to 21.7 | median of months | |
| Disease Control Rate(DCR) | Final Analysis | 86.0 | 95% Confidence Interval 73.3 to 94.2 | percentage of participants | |
| Adverse-Events | Final Analysis: Regorafenib 80mg | 22 | Participants | ||
| Adverse-Events | Final Analysis: Regorafenib 120mg | 25 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Cohort | STARTED | Regorafenib 80mg/Day | 4 | |
| Dose Escalation Cohort | STARTED | Regorafenib 120mg/Day | 7 | |
| Dose Escalation Cohort | STARTED | Regorafenib 160mg/Day | 3 | |
| Dose Escalation Cohort | COMPLETED | Regorafenib 80mg/Day | 3 | |
| Dose Escalation Cohort | COMPLETED | Regorafenib 120mg/Day | 6 | |
| Dose Escalation Cohort | COMPLETED | Regorafenib 160mg/Day | 3 | |
| Dose Escalation Cohort | NOT COMPLETED | Regorafenib 80mg/Day | 1 | |
| Dose Escalation Cohort | NOT COMPLETED | Regorafenib 120mg/Day | 1 | |
| Dose Escalation Cohort | NOT COMPLETED | Regorafenib 160mg/Day | 0 | |
| Expansion Cohort(Final Analysis) | STARTED | Regorafenib 80mg/Day | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events126
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 | palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Final Analysis: Regorafenib 80mg/Day | 13 | 22 | |
| other | palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Final Analysis: Regorafenib 120mg/Day | 20 | 25 | |
| other | palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Final Analysis: Regorafenib 160mg | 2 | 3 | |
| other | hypertension | Vascular disorders | Final Analysis: Regorafenib 80mg/Day | 11 | 22 | |
| other | hypertension | Vascular disorders | Final Analysis: Regorafenib 120mg/Day | 14 | 25 | |
| other | hypertension | Vascular disorders | Final Analysis: Regorafenib 160mg | 0 | 3 | |
| other | malaise | General disorders | Final Analysis: Regorafenib 80mg/Day | 11 | 22 | |
| other | malaise | General disorders | Final Analysis: Regorafenib 120mg/Day | 10 | 25 | |
| other | malaise | General disorders | Final Analysis: Regorafenib 160mg | 2 | 3 | |
| other | fever | General disorders | Final Analysis: Regorafenib 80mg/Day | 10 | 22 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Final Analysis: Regorafenib 80mg/Day | 0 | 22 |
| Total, all-cause mortality | Final Analysis: Regorafenib 120mg/Day | 1 | 25 |
| Total, all-cause mortality | Final Analysis: Regorafenib 160mg | 0 | 3 |
| Total, other adverse events | Final Analysis: Regorafenib 80mg/Day | 22 | 22 |
| Total, other adverse events | Final Analysis: Regorafenib 120mg/Day | 25 | 25 |
| Total, other adverse events | Final Analysis: Regorafenib 160mg | 3 | 3 |
| Total, serious adverse events | Final Analysis: Regorafenib 80mg/Day | 4 | 22 |
| Total, serious adverse events | Final Analysis: Regorafenib 120mg/Day | 5 | 25 |
| Total, serious adverse events | Final Analysis: Regorafenib 160mg | 2 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32343640 | 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.
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/NCT03406871
GET https://conductscience.org/api/trials/v1/NCT03406871/events?page=2