Trial · NCT04381650
A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors
NCT04381650, Phase 1, Phase 2, Completed, Takeda; results first posted 2025-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors. Trials, record NCT04381650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04381650
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors
- NCT number
- NCT04381650
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 161 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Advanced or Metastatic Solid Tumors
- Interventions
- TAK-981, Pembrolizumab
- First posted
- 2020-05-11
- Last updated
- 2025-12-10
- Other registries' IDs
- eudract:2020-004325-23
- Results first posted
- 2025-12-10
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Up to approximately 24 months | An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS. |
| Primary | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to Cycle 1 (each cycle was of 21 days) | DLTs were evaluated according to NCI CTCAE Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS. |
| Primary | Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | Up to approximately 24 months | AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT Consensus Grading for CRS. |
| Primary | Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs) | Up to approximately 24 months | An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. |
| Primary | Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation | Up to approximately 24 months | An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. |
| Primary | Phase 1: Number of Participants With Clinically Significant Laboratory Values | Up to approximately 24 months | Laboratory parameters included clinical chemistry, hematology, and urinalysis. Participants with at least 1 Grade 3 or 4 Lab Abnormalities were reported. |
| Primary | Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to RECIST, Version 1.1 | Up to approximately 25 months | ORR is defined as the percentage of participants who achieve Complete Response (CR) and Partial Response (PR) (determined by the investigator) during the study according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. |
| Secondary | Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Up to approximately 24 months | Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to Cycle 1 (each cycle was of 21 days) | The DLT-evaluable Analysis Set included participants enrolled in Phase 1b of the study and who experienced a DLT at any time after receiving the first dose of TAK-981 during the DLT assessment period (Cycle 1) or who received all planned TAK-981 doses and 1 administration of pembrolizumab in Cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | Up to approximately 24 months | Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs) | Up to approximately 24 months | Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation | Up to approximately 24 months | Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Clinically Significant Laboratory Values | Up to approximately 24 months | Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to RECIST, Version 1.1 | Up to approximately 25 months | Response-Evaluable Analysis Set included participants who had received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | Pharmacokinetic (PK) Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Number of participants analyzed is the number of participants available for analysis during the specified time-point. | nanograms per milliliter (ng/ml) | MEAN |
| SECONDARY | Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | PK Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Number of participants analyzed is the number of participants available for analysis during the specified time-point. | hours | MEDIAN |
| SECONDARY | Phase 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | PK Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants with data available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point. | hours*ng/mL | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group270
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Dose Escalation: TAK-981 40 mg | 3 | Participants | ||
| Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Dose Escalation: TAK-981 60 mg | 6 | Participants | ||
| Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Dose Escalation: TAK-981 90 mg | 33 | Participants | ||
| Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Dose Escalation: TAK-981 120 mg | 19 | Participants | ||
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Dose Escalation: TAK-981 40 mg | 0 | Participants | ||
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Dose Escalation: TAK-981 60 mg | 0 | Participants | ||
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Dose Escalation: TAK-981 90 mg | 2 | Participants | ||
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Dose Escalation: TAK-981 120 mg | 1 | Participants | ||
| Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | Dose Escalation: TAK-981 40 mg | 0 | Participants | ||
| Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | Dose Escalation: TAK-981 60 mg | 2 | Participants |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b (Dose Escalation) | STARTED | Dose Escalation: TAK-981 40 mg | 3 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Escalation: TAK-981 60 mg | 6 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Escalation: TAK-981 90 mg | 33 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Escalation: TAK-981 120 mg | 19 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg | 0 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg | 0 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg | 0 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg | 0 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg | 0 | |
| Phase 1b (Dose Escalation) | STARTED | Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events3,575
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 | Abdominal distension | Gastrointestinal disorders | Dose Escalation: TAK-981 40 mg | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation: TAK-981 60 mg | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation: TAK-981 90 mg | 1 | 33 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation: TAK-981 120 mg | 0 | 19 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg | 0 | 14 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg | 0 | 9 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg | 0 | 21 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg | 2 | 9 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg | 0 | 28 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg | 0 | 15 |
1 to 10 of 3,575Source ClinicalTrials.gov
See all 3,575 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation: TAK-981 40 mg | 2 | 3 |
| Total, all-cause mortality | Dose Escalation: TAK-981 60 mg | 2 | 6 |
| Total, all-cause mortality | Dose Escalation: TAK-981 90 mg | 8 | 33 |
| Total, all-cause mortality | Dose Escalation: TAK-981 120 mg | 4 | 19 |
| Total, all-cause mortality | Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg | 2 | 14 |
| Total, all-cause mortality | Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg | 4 | 9 |
| Total, all-cause mortality | Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg | 9 | 21 |
| Total, all-cause mortality | Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg | 2 | 9 |
| Total, all-cause mortality | Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg | 8 | 28 |
| Total, all-cause mortality | Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg | 2 | 15 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04381650
GET https://conductscience.org/api/trials/v1/NCT04381650/registered?page=2