Select Clinical Trials Currently Enrolling Patients with Thyroid Cancer

August 2017, Vol 7, No 8 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with thyroid cancer for inclusion in investigations of new therapies or new regimens of existing treatments for patients with thyroid cancer. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to an appropriate clinical trial.

  • 1 Lenvatinib in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer

    The objective of this randomized, parallel-assignment, phase 3 clinical trial is to compare the progression-free survival (PFS) of participants with radioiodine (131 I)-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the previous 12 months who received lenvatinib (Lenvima) 24 mg by continuous, once-daily oral dosing versus placebo. Individuals aged ≥18 years with differentiated thyroid cancer and adequate bone marrow function who have never received lenvatinib may be eligible for enrollment if other criteria are met. Patients will receive lenvatinib or placebo.

    The primary outcome measure is PFS. The secondary outcome measures include overall response rate (ORR), overall survival (OS), and the number of participants with treatment-emergent adverse events and serious adverse events. This study plans to enroll 150 patients in China. For more information, contact Eisai Medical Information at 888-274-2378 or esi_medinfo@eisai.com. The NLM Identifier is NCT02966093.

  • 2 Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer

    This nonrandomized, parallel-assignment, phase 2, open-label clinical trial will assess the efficacy and safety of pembrolizumab (Keytruda) in patients with medullary thyroid cancer. Patients aged ≥18 years who have recurrent or metastatic medullary thyroid cancer, and for whom surgery is not a curative option, may be eligible for enrollment if other criteria are met. Participants with or without previous vaccine therapy will receive pembrolizumab.

    The primary outcome measure is to determine whether administering a PD-1 inhibitor to patients with medullary thyroid cancer will permit a modest fraction to be able to experience a ≥50% decline in calcitonin levels or have a partial or complete response on imaging. The secondary outcome measures are to determine the impact of previous therapeutic cancer vaccination on response rates, evaluate immune responses in each cohort, evaluate changes in carcinoembryonic antigen and calcitonin kinetics, evaluate impact on PFS and OS, and evaluate the safety of anti–PD-1/PD-L1 therapy with pembrolizu­mab. This study expects to enroll 32 patients at the National Institutes of Health Clinical Center in Maryland. For more information, contact Myrna Rauckhorst, RN, at 240-­460-6069 or mrauckhorst@mail.nih.gov. The NLM Identifier is NCT03072160.

  • 3 GI-6207 Vaccine for Advanced Medullary Thyroid Cancer

    The purpose of this randomized, parallel-assignment, open-label, phase 2 clinical trial is to assess the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid cancer. Patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and with elevated calcitonin levels may be eligible for enrollment if other criteria are met. Eligible patients will receive GI-6207 for 1 year or will undergo 6 months of surveillance, followed by GI-6207 for 1 year.

    The primary outcome measure is calcitonin growth rate kinetics after 6 months of therapy in patients with medullary thyroid cancer. The secondary outcome measures are carcinoembryonic antigen–specific T-cells at 3 months compared with baseline and the time to disease progression. This study plans to enroll 37 patients at the National Institutes of Health Clinical Center in Maryland. For more information, contact Myrna Rauckhorst, RN, at 240-460-6069 or mrauckhorst@mail.nih.gov, or Ravi A. Madan, MD, at 301-496-3493 or rm480i@nih.gov. The NLM Identifier is NCT01856920.

  • 4 Everolimus and Lenvatinib in Patients with Metastatic Differentiated Thyroid Cancer That Progressed After Lenvatinib Monotherapy

    This single-group assignment, open-label, phase 2 study will assess the efficacy and safety of everolimus (Afinitor) in combination with lenvatinib in patients with metastatic differentiated thyroid cancer that progressed after lenvatinib monotherapy. Patients aged ≥18 years with an ECOG performance status score <2 may be eligible for enrollment if other criteria are met. Patients will receive everolimus and lenvatinib.

    The primary outcome measure is the number of patients with PFS. This study expects to enroll 40 patients at the Abramson Cancer Center of the University of Pennsylvania. For more information, contact Marcia Brose, MD, PhD, at 855-216-0098 or PennCancerTrials@emergingmed.com. The NLM Identifier is NCT03139747.

  • 5 Safety and Efficacy of MLN0128 in Metastatic Anaplastic Thyroid Cancer

    The purpose of this single-group assignment, phase 2 clinical trial is to investigate the safety and efficacy of the targeted drug MLN0128 in patients with metastatic anaplastic thyroid cancer. Patients aged ≥18 years with newly diagnosed or refractory or metastatic anaplastic thyroid cancer and with an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive MLN0128.

    The primary outcome measure is PFS. The secondary outcome measures are ORR, OS, the number of patients with serious and nonserious adverse events, and the identification of biomarkers that are predictive of response to therapy with MLN0128. This study plans to enroll 25 patients at the Dana-Farber Cancer Institute in Boston, MA. For more information, contact Jochen Lorch, MD, at 617-632-3090 or jlorch@partners.org. The NLM Identifier is NCT02244463.

  • 6 Two Different Doses of Cabozantinib in Progressive, Metastatic Medullary Thyroid Cancer: EXAMINER Clinical Trial

    This randomized, parallel-assignment, phase 4 clinical trial will evaluate the efficacy and safety of cabozantinib (Cabometyx) at 60 mg daily versus 140 mg daily in patients with progressive, metastatic medullary thyroid cancer. Patients aged ≥18 years with a histologically confirmed diagnosis of medullary thyroid cancer and with an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive cabozantinib 140 mg or 60 mg daily as capsules and placebo tablets administered orally once daily.

    The primary outcome measure is PFS. The secondary outcome measure is objective response rate. Other outcome measures include safety and tolerability. This study plans to enroll 188 patients at multiple locations abroad. For more information, contact Exelixis Clinical Trials at 888-393-5494. The NLM Identifier is NCT01896479.

  • 7 Vemurafenib Neoadjuvant Therapy in Locally Advanced Thyroid Cancer

    The purpose of this nonrandomized, parallel-assignment, open-label, phase 2 clinical trial is to assess how vemurafenib (Zelboraf) may affect certain biomarkers in patients with primary papillary thyroid cancer. Biomarkers are found in the blood or tissue and may be related to how well patients respond to the study drug. Patients aged ≥18 years with stage T3 or T4 primary papillary thyroid cancer and an ECOG performance status ≤2 may be eligible for enrollment if other criteria are met. All patients will first receive vemurafenib before surgery. Next, patients will receive vem­urafenib after surgery; no vemurafenib after surgery; or continue vemurafenib, unless there is evidence of progressive disease, in which case these patients will undergo surgery and follow the protocol of the patients in the other 2 groups.

    The primary outcome measure is the percentage change in extracellular-signal–regulated kinase phosphorylation and tumor size. The secondary outcome measure is the objective response rate. This study plans to enroll 22 patients at the University of Texas M.D. Anderson Cancer Center. For more information, contact Madonna M. Pool, MSN, at 713-792-9851. The NLM Identifier is NCT01709292.

  • 8 Sorafenib Therapy with and without Everolimus in Patients with Advanced Hurthle-Cell Thyroid Cancer

    The purpose of this randomized, crossover-assignment, phase 2 clinical trial is to assess the effects of using sorafenib (Nexavar) with or without everolimus (Afinitor) in patients with Hurthle-cell thyroid cancer that is refractory to radioactive iodine therapy.

    Patients aged ≥18 years who have metastatic or locally advanced and unresectable Hurthle-cell thyroid cancer and an ECOG performance status ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive sorafenib alone or in combination with everolimus.

    The primary outcome measure is PFS. The secondary outcome measures are OS, confirmed response rate, and the occurrence of adverse events. This study plans to enroll 34 patients at multiple locations across the United States. For more information, contact Eric Sherman, MD, at 646-888-4234. The NLM Identifier is NCT02143726.

  • 9 Gemcitabine plus Oxaliplatin for Advanced Refractory Thyroid Cancer

    The purpose of this single-group assignment, open-label, phase 2 clinical trial is to evaluate the response rate with gemcitabine (Gemzar) plus oxaliplatin (Eloxatin) in patients with advanced radioiodine-refractory differentiated thyroid cancer after antiangiogenic agents or in case of contraindication to antiangiogenic therapy. Patients aged ≥18 years with differentiated or poorly differentiated thyroid cancer that is metastatic or unresectable and with an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive gemcitabine plus oxaliplatin.

    The primary outcome measure is ORR. The secondary outcome measures include the number of adverse events and serious adverse events, early metabolic response on 18F-FDG-TEP/CT, disease control rate, the time to disease progression, PFS, OS, and quality of life. This study expects to enroll 30 patients at the Groupe Hospitalier Pitié Salpetriere in France. For more information, contact Laurence Leenhardt, MD, PhD, at laurence.leenhardt@psl.aphp.fr, or Johanna Wassermann at johanna.wassermann@psl.fr. The NLM Identifier is NCT02472080.

  • 10 Regorafenib as Second- or Third-Line Therapy in Metastatic Medullary Thyroid Cancer

    This open-label, single-group assignment, phase 2 clinical trial is assessing the targeted therapy drug regorafenib (Stivarga) as a possible treatment option for thyroid cancer. Patients aged ≥18 years with a life expectancy of at least 3 months and an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive regorafenib.

    The primary outcome measures are response and PFS. The secondary outcome measures are safety variables (eg, adverse events, laboratory changes), radiographic response, and biomarkers associated with response. This study plans to enroll 33 patients at the Dana-Farber Cancer Institute in Boston, MA. For more information, contact Jochen Lorch, MD, at 617-632-3090 or jlorch@partners.org. The NLM Identifier is NCT02657551.