Complete Response Rate (Cohort 1)
Primary
· 26 months
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will use a one-stage binomial design.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0 |
Last reviewed · How we verify
NCT02973997
Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)
Completed
Phase 2
Results posted
Last updated 29 August 2025
What this trial tests
Phase 2 trial testing Laboratory Biomarker Analysis in Columnar Cell Variant Thyroid Gland Papillary Carcinoma in 57 participants. Completed in 8 October 2023.
Timeline
7 February 2018
Primary endpoint
15 August 2022
15 August 2022
8 October 2023
Quick facts
| Lead sponsor | Academic and Community Cancer Research United |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 57 |
| Start date | 7 February 2018 |
| Primary completion | 15 August 2022 |
| Estimated completion | 8 October 2023 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Laboratory Biomarker Analysis — full drug profile →
- Lenvatinib (LENVATINIB) — full drug profile →
- Lenvatinib Mesylate — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Columnar Cell Variant Thyroid Gland Papillary Carcinoma — all drugs for Columnar Cell Variant Thyroid Gland Papillary Carcinoma →
- Follicular Variant Thyroid Gland Papillary Carcinoma — all drugs for Follicular Variant Thyroid Gland Papillary Carcinoma →
- Metastatic Thyroid Gland Follicular Carcinoma — all drugs for Metastatic Thyroid Gland Follicular Carcinoma →
- Metastatic Thyroid Gland Papillary Carcinoma — all drugs for Metastatic Thyroid Gland Papillary Carcinoma →
Sponsor
Academic and Community Cancer Research United — full company profile →
Who can join
18 and older, any sex, with Columnar Cell Variant Thyroid Gland Papillary Carcinoma or Follicular Variant Thyroid Gland Papillary Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Confirmed Response Rate (Cohort 2)
Primary
· 27 months
Assessed by RECIST 1.1. Will use a 2-stage Simon Optimal MinMax design.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 2 | 16 |
Number of Patients Experiencing Grade 3+ Adverse Events
Secondary
· 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.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 26 | |
| Cohort 2 | 14 |
Progression Free Survival (PFS)
Secondary
· 12 months
The distribution of PFS will be estimated using the method of Kaplan-Meier.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 96.6 | 90.1 – 100.0 |
| Cohort 2 | 48.0 | 31.9 – 72.2 |
Overall Survival (OS)
Secondary
· 12 months
The distribution of survival at 12 months will be estimated using the method of Kaplan-Meier.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 96.6 | 90.1 – 100.0 |
| Cohort 2 | 76.0 | 61.0 – 94.7 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 27 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1
Serious: 16/30 (53%)
Deaths: 7/30
Cohort 2
Serious: 8/25 (32%)
Deaths: 19/25
Serious adverse events (43 terms)
| Reaction | System | Cohort 1 | Cohort 2 |
|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — |
| Skin infection | Infections and infestations | — | — |
| Lipase increased | Investigations | — | — |
| Serum amylase increased | Investigations | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Myocarditis | Cardiac disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Gastric ulcer | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Gen disord and admin site conds-Oth spec | General disorders | — | — |
| Malaise | General disorders | — | — |
| Pain | General disorders | — | — |
| Enterocolitis infectious | Infections and infestations | — | — |
| Hepatitis viral | Infections and infestations | — | — |
| Infections and infestations - Oth spec | Infections and infestations | — | — |
| Lung infection | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — |
Other adverse events (126 terms — click to expand)
| Reaction | System | Cohort 1 | Cohort 2 |
|---|---|---|---|
| Hypertension | Vascular disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Weight loss | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Palmar-plantar erythrodysesthesia syndrm | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | — | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — | — |
| Gen disord and admin site conds-Oth spec | General disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Musculoskeletal, conn tissue - Oth spec | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Pain | General disorders | — | — |
| White blood cell decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Resp, thoracic, mediastinal - Oth spec | Respiratory, thoracic and mediastinal disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Atrial fibrillation, Pancreatitis, Skin infection, Lipase increased, Serum amylase increased, Hyponatremia, Dyspnea, Hypertension.
Data from ClinicalTrials.gov NCT02973997 adverse events section.
Sponsor's own description
This phase II trial studies how well pembrolizumab and lenvatinib work in treating patients with differentiated thyroid cancer that has spread to other places in the body or has come back and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Phase IB/II Trial of Lenvatinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma, Endometrial Cancer, and Other Selected Advanced Solid Tumors.
Taylor MH, Lee CH, Makker V, Rasco D, et al · · 2020 · cited 330× · PMID 31961766 · DOI 10.1200/jco.19.01598 -
Targeted Therapy for Advanced Thyroid Cancer: Kinase Inhibitors and Beyond.
Cabanillas ME, Ryder M, Jimenez C. · · 2019 · cited 247× · PMID 31322645 · DOI 10.1210/er.2019-00007 -
Updates on the Management of Thyroid Cancer.
Araque KA, Gubbi S, Klubo-Gwiezdzinska J. · · 2020 · cited 115× · PMID 32040962 · DOI 10.1055/a-1089-7870 -
The Immune Landscape of Thyroid Cancer in the Context of Immune Checkpoint Inhibition.
Varricchi G, Loffredo S, Marone G, Modestino L, et al · · 2019 · cited 78× · PMID 31412566 · DOI 10.3390/ijms20163934 -
Molecular Alterations in Thyroid Cancer: From Bench to Clinical Practice.
Tirrò E, Martorana F, Romano C, Vitale SR, et al · · 2019 · cited 63× · PMID 31540307 · DOI 10.3390/genes10090709 -
Novel Targeted Therapies for Metastatic Thyroid Cancer-A Comprehensive Review.
Al-Jundi M, Thakur S, Gubbi S, Klubo-Gwiezdzinska J. · · 2020 · cited 56× · PMID 32751138 · DOI 10.3390/cancers12082104 -
Thyroid Cancers: From Surgery to Current and Future Systemic Therapies through Their Molecular Identities.
Lorusso L, Cappagli V, Valerio L, Giani C, et al · · 2021 · cited 51× · PMID 33803747 · DOI 10.3390/ijms22063117 -
Perspectives on the Treatment of Advanced Thyroid Cancer: Approved Therapies, Resistance Mechanisms, and Future Directions.
Porter A, Wong DJ. · · 2020 · cited 44× · PMID 33569345 · DOI 10.3389/fonc.2020.592202
Verify or expand the search:
- PubMed search for NCT02973997
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02973997 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Academic and Community Cancer Research United
- Last refreshed: 29 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02973997.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing