Trial · NCT05014828
To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors
NCT05014828, Phase 2, Completed, BeiGene; results first posted 2025-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors. Trials, record NCT05014828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05014828
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors
- NCT number
- NCT05014828
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Advanced Solid Tumor
- Interventions
- lenvatinib, Tislelizumab
- First posted
- 2021-08-20
- Last updated
- 2025-08-24
- Results first posted
- 2025-08-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Run-in: Number of Participants With Adverse Events (AEs) | From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose. | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement. A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator. |
| Primary | Overall Response Rate (ORR) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Progression Free Survival (PFS) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Duration of Response (DOR) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm. |
| Secondary | Disease Control Rate (DCR) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | DCR was defined as the percentage of participants who demonstrated a confirmed complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, in accordance with the RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions with no new lesions observed. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum of diameters as the reference. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), using the smallest sum of diameters recorded while on study as the reference. |
| Secondary | Overall Survival (OS) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | OS was defined as the time from randomization to the documented date of death for participants who died on or before the data cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the data cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first. |
| Secondary | Number of Participants Experiencing Adverse Events (AEs) | From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months) | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. |
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 | Safety Run-in: Number of Participants With Adverse Events (AEs) | From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose. | The Safety run-in set is defined as all participants in the safety run-in stage. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate (ORR) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | Safety Analysis Set: Participants who received ≥ 1 dose of study drug(s) Evaluable Analysis Set: Participants who received ≥ 1 dose of study drug(s), have evaluable disease at baseline, and have ≥ 1 evaluable postbaseline tumor response assessment unless any clinical progressive disease or death occurred before the first postbaseline tumor assessment. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | Safety analysis set | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | Evaluable Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in this analysis, | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | Evaluable analysis set and Safety Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) | Safety Analysis Set | Month | MEDIAN |
| SECONDARY | Number of Participants Experiencing Adverse Events (AEs) | From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months) | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Run-in: Number of Participants With Adverse Events (AEs) | Safety Run-In | Number of Participants with any TEAEs | 6 | Participants | |
| Safety Run-in: Number of Participants With Adverse Events (AEs) | Safety Run-In | Number of Participants with any SAEs | 4 | Participants | |
| Safety Run-in: Number of Participants With Adverse Events (AEs) | Safety Run-In | Number of Participants with any DLTs | 0 | Participants | |
| Overall Response Rate (ORR) | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Safety Analysis Set | 29.6 | 95% Confidence Interval 13.8 to 50.2 | Percentage of participants |
| Overall Response Rate (ORR) | Renal Cell Carcinoma (RCC) | Safety Analysis Set | 60.9 | 95% Confidence Interval 38.5 to 80.3 | Percentage of participants |
| Overall Response Rate (ORR) | Non-Small Cell Lung Cancer (NSCLC) | Safety Analysis Set | 20.0 | 95% Confidence Interval 0.5 to 71.6 | Percentage of participants |
| Overall Response Rate (ORR) | Gastric Cancer (GC) | Safety Analysis Set | 33.3 | 95% Confidence Interval 0.8 to 90.6 | Percentage of participants |
| Overall Response Rate (ORR) | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Evaluable Analysis Set | 33.3 | 95% Confidence Interval 15.6 to 55.3 | Percentage of participants |
| Overall Response Rate (ORR) | Renal Cell Carcinoma (RCC) | Evaluable Analysis Set | 66.7 | 95% Confidence Interval 43.0 to 85.4 | Percentage of participants |
| Overall Response Rate (ORR) | Non-Small Cell Lung Cancer (NSCLC) | Evaluable Analysis Set | 20.0 | 95% Confidence Interval 0.5 to 71.6 | Percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 27 | |
| Overall Study | STARTED | Renal Cell Carcinoma (RCC) | 23 | |
| Overall Study | STARTED | Non-Small Cell Lung Cancer (NSCLC) | 5 | |
| Overall Study | STARTED | Gastric Cancer (GC) | 3 | |
| Overall Study | Treated | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 27 | |
| Overall Study | Treated | Renal Cell Carcinoma (RCC) | 23 | |
| Overall Study | Treated | Non-Small Cell Lung Cancer (NSCLC) | 5 | |
| Overall Study | Treated | Gastric Cancer (GC) | 3 | |
| Overall Study | Enrolled in Safety Run-in Stage | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 2 | |
| Overall Study | Enrolled in Safety Run-in Stage | Renal Cell Carcinoma (RCC) | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events868
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 | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 7 | 27 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Renal Cell Carcinoma (RCC) | 5 | 23 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Non-Small Cell Lung Cancer (NSCLC) | 1 | 5 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Gastric Cancer (GC) | 0 | 3 | 0 |
| other | Hypercoagulation | Blood and lymphatic system disorders | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 0 | 27 | 0 |
| other | Hypercoagulation | Blood and lymphatic system disorders | Renal Cell Carcinoma (RCC) | 1 | 23 | 1 |
| other | Hypercoagulation | Blood and lymphatic system disorders | Non-Small Cell Lung Cancer (NSCLC) | 0 | 5 | 0 |
| other | Hypercoagulation | Blood and lymphatic system disorders | Gastric Cancer (GC) | 0 | 3 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 0 | 27 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Renal Cell Carcinoma (RCC) | 3 | 23 | 4 |
1 to 10 of 868Source ClinicalTrials.gov
See all 868 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 11 | 27 |
| Total, all-cause mortality | Renal Cell Carcinoma (RCC) | 6 | 23 |
| Total, all-cause mortality | Non-Small Cell Lung Cancer (NSCLC) | 0 | 5 |
| Total, all-cause mortality | Gastric Cancer (GC) | 0 | 3 |
| Total, other adverse events | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 27 | 27 |
| Total, other adverse events | Renal Cell Carcinoma (RCC) | 21 | 23 |
| Total, other adverse events | Non-Small Cell Lung Cancer (NSCLC) | 5 | 5 |
| Total, other adverse events | Gastric Cancer (GC) | 3 | 3 |
| Total, serious adverse events | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | 17 | 27 |
| Total, serious adverse events | Renal Cell Carcinoma (RCC) | 11 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT05014828
GET https://conductscience.org/api/trials/v1/NCT05014828/results?page=2