Trial · NCT02860546
A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC
NCT02860546, Phase 2, Completed, Taiho Oncology, Inc.; results first posted 2021-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC. Trials, record NCT02860546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02860546
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC
- NCT number
- NCT02860546
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Refractory Metastatic Colorectal Cancer
- Interventions
- TAS-102, nivolumab
- First posted
- 2016-08-09
- Last updated
- 2024-09-03
- Results first posted
- 2021-07-26
- Limitations and caveats
- After interim analysis, per study design plan, the trial was stopped for futility before enrollment into Stage 2.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune-Related Overall Response Rate (irORR) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | irORR was defined as the percentage of participants achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. Per irRC criteria, Complete Response (irCR) was defined as the disappearance of all tumor lesions (measurable or not, and no new lesions)., Partial Response (irPR) was defined as a decrease in the sum of the products of the two largest perpendicular diameters (SPD) by 50 percent (%) or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) was defined as the failure to meet criteria for irCR or irPR in absence of progressive disease (irPD), irPD was defined as at least 25% increase in SPD relative to nadir. |
| Secondary | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (each cycle is of 4 weeks) | DLT: defined as occurrence of any of the following- Hematological toxicities: * Grade 4 neutropenia lasting greater than(\>)7 days * Grade 4 febrile neutropenia and fever greater than or equal to (\>=)38 degree celsius for over 1 hour * Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding or requiring transfusions Non-hematological toxicities: * Grade 3 or grade 4 non-hematologic toxicity (excluding alopecia, nausea, vomiting, diarrhea) * Grade 3 or grade 4 nausea/vomiting lasting \>48 hours and uncontrolled by aggressive anti-emetic therapy, including serotonin 5-HT3 receptor antagonists (e.g, ondansetron) * Grade 3 or grade 4 diarrhea lasting \> 48 hours and unresponsive to antidiarrheal medication Drug-related toxicities: * Any drug-related toxicity resulting in \> 2 weeks delay in initiation of Cycle 2 (i.e, cannot start Cycle 2 until Day 43 or later) * Any drug-related toxicity that prevents completion of 80% compliance for either drug in Cycle 1 |
| Secondary | Recommended Phase 2 Dose (RP2D) | Cycle 1 (each cycle is of 4 weeks) | RP2D of TAS-102 was evaluated based on the safety and tolerability of the combination therapy of TAS-102 and Nivolumab. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | An adverse event (AE) was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs: AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. |
| Secondary | Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Hematological and chemistry laboratory tests abnormalities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE). |
| Secondary | Overall Response Rate (ORR) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) version 1.1.CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (\<)10 millimeters (mm). PR was defined as at least a 30 % decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. |
| Secondary | Progression-Free Survival (PFS) Based on Immune Related Response-Criteria (irRC) | From the first dose of study treatment to disease progression or death (up to 53 weeks) | Immune-related progression free survival was defined as the time (in months) from the date of first dose of study treatment until the date of the investigator-assessed radiological disease progression (based on irRC) or death due to any cause. Participants who were alive with no disease progression at the moment of the analysis cut-off date was censored at the date of the last tumor assessment. Per irRC criteria disease progression defined as at least 25% increase in SPD relative to nadir. Analysis was performed using Kaplan-Meier estimates. |
| Secondary | Progression-Free Survival (PFS) Based on RECIST Criteria | From the first dose of study treatment to disease progression or death (up to 53 weeks) | Progression free survival was defined as the time (in months) from the date of first dose of study treatment until the date of the investigator-assessed radiological disease progression (based on RECIST 1.1) or death due to any cause. Per RECIST criteria disease progression defined as least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicated progression. |
| Secondary | Disease Control Rate (DCR) Based on irRC Criteria | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | DCR was defined as the percentage of participants with objective evidence of radiologic complete response (CR), partial response (PR), or stable disease (SD) and was based on the overall best response from each participant as determined from investigator response assessments and following irRC criteria. Per irRC criteria, CR was defined as the disappearance of all tumor lesions (measurable or not, and no new lesions). PR was defined as a decrease in the sum of the products of the two largest perpendicular diameters by 50% or greater by a consecutive assessment at least 4 weeks after first documentation. SD was defined as the failure to meet criteria for irCR or irPR in absence of in absence of irPD. |
| Secondary | Disease Control Rate (DCR) Based on RECIST Criteria | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | DCR was defined as the percentage of participants with objective evidence of radiologic CR, PR, or SD and was based on the overall best response from each participant as determined from investigator response assessments and following RECIST Criteria version 1.1. Per RECIST Criteria CR defined as disappearance of all target lesions. Reduction in any pathological lymph nodes in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameters during study. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune-Related Overall Response Rate (irORR) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population (all participants who received at least 1 dose of study drug) who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (each cycle is of 4 weeks) | DLT Evaluable (DLTE) population included all participants in the safety population in Stage 1, prior to confirming the recommended dose, who completed at least 1 cycle (28 days) of study treatment with at least 80% of the study treatment administered, unless the treatment was interrupted because of a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Recommended Phase 2 Dose (RP2D) | Cycle 1 (each cycle is of 4 weeks) | DLTE population included all participants in the safety population in Stage 1, prior to confirming the recommended dose, who completed at least 1 cycle (4 weeks) of study treatment with at least 80% of the study treatment administered, unless the treatment was interrupted because of a DLT. | mg/m^2 | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Safety population included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Safety population included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) Based on Immune Related Response-Criteria (irRC) | From the first dose of study treatment to disease progression or death (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Based on RECIST Criteria | From the first dose of study treatment to disease progression or death (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Based on irRC Criteria | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Based on RECIST Criteria | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immune-Related Overall Response Rate (irORR) | TAS-102 + Nivolumab | 0 | percentage of participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | TAS-102 + Nivolumab | 0 | Participants | ||
| Recommended Phase 2 Dose (RP2D) | TAS-102 + Nivolumab | 35 | mg/m^2 | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TAS-102 + Nivolumab | Participants with TEAEs | 18 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TAS-102 + Nivolumab | Participants with TESAEs | 6 | participants | |
| Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | TAS-102 + Nivolumab | Grade 4: Neutropenia (neutrophils low) | 3 | participants | |
| Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | TAS-102 + Nivolumab | Grade 4: Anemia (hemoglobin low) | 1 | participants | |
| Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | TAS-102 + Nivolumab | Grade 4: Leukopenia (leukocytes low) | 0 | participants | |
| Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | TAS-102 + Nivolumab | Grade 4: Lymphopenia (lymphocytes low) | 0 | participants | |
| Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | TAS-102 + Nivolumab | Grade 4: Thrombocytopenia (platelets low) | 0 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAS-102 + Nivolumab | 18 | |
| Overall Study | COMPLETED | TAS-102 + Nivolumab | 0 | |
| Overall Study | NOT COMPLETED | TAS-102 + Nivolumab | 18 |
Source ClinicalTrials.gov
Adverse events72
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 | TAS-102 + Nivolumab | 5 | 18 | 11 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | TAS-102 + Nivolumab | 1 | 18 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | TAS-102 + Nivolumab | 3 | 18 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TAS-102 + Nivolumab | 2 | 18 | 2 |
| other | Tinnitus | Ear and labyrinth disorders | TAS-102 + Nivolumab | 1 | 18 | 1 |
| other | Lacrimation increased | Eye disorders | TAS-102 + Nivolumab | 1 | 18 | 1 |
| other | Photopsia | Eye disorders | TAS-102 + Nivolumab | 1 | 18 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | TAS-102 + Nivolumab | 1 | 18 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | TAS-102 + Nivolumab | 5 | 18 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | TAS-102 + Nivolumab | 2 | 18 | 2 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS-102 + Nivolumab | 0 | 18 |
| Total, other adverse events | TAS-102 + Nivolumab | 18 | 18 |
| Total, serious adverse events | TAS-102 + Nivolumab | 6 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33544407 | 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.
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