Trial · NCT02973997
Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)
NCT02973997, Phase 2, Completed, Academic and Community Cancer Research United; results first posted 2023-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC). Trials, record NCT02973997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02973997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)
- NCT number
- NCT02973997
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
Columnar Cell Variant Thyroid Gland Papillary Carcinoma, Follicular Variant Thyroid Gland Papillary Carcinoma, Metastatic Thyroid Gland Follicular Carcinoma, Metastatic Thyroid Gland Papillary Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Follicular Carcinoma, Recurrent Thyroid Gland Papillary Carcinoma, Stage III Differentiated Thyroid Gland Carcinoma AJCC v7, Stage III Thyroid Gland Follicular Carcinoma AJCC v7, Stage III Thyroid Gland Papillary Carcinoma AJCC v7, Stage IV Thyroid Gland Follicular Carcinoma AJCC v7, Stage IV Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7, Tall Cell Variant Thyroid Gland Papillary Carcinoma, Thyroid Gland Hurthle Cell Carcinoma, Unresectable Differentiated Thyroid Gland Carcinoma, Unresectable Thyroid Gland Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Lenvatinib, Lenvatinib Mesylate, Pembrolizumab
- First posted
- 2016-11-28
- Last updated
- 2025-08-29
- Results first posted
- 2023-10-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate (Cohort 1) | 26 months | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will use a one-stage binomial design. |
| Primary | Confirmed Response Rate (Cohort 2) | 27 months | Assessed by RECIST 1.1. Will use a 2-stage Simon Optimal MinMax design. |
| Secondary | Number of Patients Experiencing Grade 3+ Adverse Events | 27 months | Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. All patients that have initiated treatment will be considered evaluable for assessing adverse events. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the grade 2+ adverse events will be assessed, regardless of relationship to the study treatment. |
| Secondary | Progression Free Survival (PFS) | 12 months | The distribution of PFS will be estimated using the method of Kaplan-Meier. |
| Secondary | Overall Survival (OS) | 12 months | The distribution of survival at 12 months will be estimated using the method of Kaplan-Meier. |
| Other | Biomarker Levels Analysis Following Pembrolizumab and Lenvatinib Combination Therapy | Up to 3 years | All analyses with respect to the translational component of this study are intended to be hypothesis-generating and descriptive in manner. Clinical data (i.e. CR rates confirmed response rates, PFS, OS, etc.) will be correlated with tumor marker data of interest (CD8+, PD-L1, PD-L2, T cell functional capacity markers, anti-thyroglobulin antibody levels, tumor mutation status, and other markers). The Chi-Square (or Fisher's Exact test) will be used to assess the association of categorical clinical data with categorical biomarker data. Time-to-event clinical data (PFS, OS) will be correlated with biomarker data using Kaplan-Meier methodology and Cox regression models. Logistic regression models will also be used to predict binary clinical data with baseline biomarker data. Finally, graphical methods and descriptive statistics will be used to summarize the data as well. Two-sided p-values \< 0.05 will be considered statistically significant. |
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 | Complete Response Rate (Cohort 1) | 26 months | All evaluable patients in cohort 1 were analyzed for this endpoint. | percentage of participants | NUMBER |
| PRIMARY | Confirmed Response Rate (Cohort 2) | 27 months | All evaluable patients in cohort 2 were analyzed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Number of Patients Experiencing Grade 3+ Adverse Events | 27 months | All evaluable patients were analyzed for this endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | 12 months | All evaluable patients were analyzed for this endpoint. | percentage of patients alive and PF | NUMBER |
| SECONDARY | Overall Survival (OS) | 12 months | All evaluable patients were analyzed for this endpoint. | percentage of patients alive | NUMBER |
| OTHER_PRE_SPECIFIED | Biomarker Levels Analysis Following Pembrolizumab and Lenvatinib Combination Therapy | Up to 3 years |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate (Cohort 1) | Cohort 1 | 0 | percentage of participants | ||
| Confirmed Response Rate (Cohort 2) | Cohort 2 | 16 | percentage of participants | ||
| Number of Patients Experiencing Grade 3+ Adverse Events | Cohort 1 | 26 | Participants | ||
| Number of Patients Experiencing Grade 3+ Adverse Events | Cohort 2 | 14 | Participants | ||
| Progression Free Survival (PFS) | Cohort 1 | 96.6 | 95% Confidence Interval 90.1 to 100.0 | percentage of patients alive and PF | |
| Progression Free Survival (PFS) | Cohort 2 | 48.0 | 95% Confidence Interval 31.9 to 72.2 | percentage of patients alive and PF | |
| Overall Survival (OS) | Cohort 1 | 96.6 | 95% Confidence Interval 90.1 to 100.0 | percentage of patients alive | |
| Overall Survival (OS) | Cohort 2 | 76.0 | 95% Confidence Interval 61.0 to 94.7 | percentage of patients alive |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 30 | |
| Overall Study | STARTED | Cohort 2 | 25 | |
| Overall Study | COMPLETED | Cohort 1 | 8 | |
| Overall Study | COMPLETED | Cohort 2 | 2 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 22 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 23 |
Source ClinicalTrials.gov
Adverse events338
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 | Anemia | Blood and lymphatic system disorders | Cohort 1 | 4 | 30 | 13 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2 | 4 | 25 | 26 |
| other | Atrial fibrillation | Cardiac disorders | Cohort 1 | 0 | 30 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Cohort 2 | 2 | 25 | 36 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Cohort 1 | 1 | 30 | 1 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Cohort 2 | 0 | 25 | 0 |
| other | Chest pain - cardiac | Cardiac disorders | Cohort 1 | 0 | 30 | 0 |
| other | Chest pain - cardiac | Cardiac disorders | Cohort 2 | 1 | 25 | 2 |
| other | Heart failure | Cardiac disorders | Cohort 1 | 0 | 30 | 0 |
| other | Heart failure | Cardiac disorders | Cohort 2 | 1 | 25 | 2 |
1 to 10 of 338Source ClinicalTrials.gov
See all 338 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 7 | 30 |
| Total, all-cause mortality | Cohort 2 | 19 | 25 |
| Total, other adverse events | Cohort 1 | 30 | 30 |
| Total, other adverse events | Cohort 2 | 25 | 25 |
| Total, serious adverse events | Cohort 1 | 16 | 30 |
| Total, serious adverse events | Cohort 2 | 8 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33720068 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: Number of Patients Experiencing Grade 3+ Adverse Events | Trial comparisons |
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: serious adverse events | Trial comparisons |
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/NCT02973997
GET https://conductscience.org/api/trials/v1/NCT02973997/events?page=2