Table 2.
Ongoing clinical trials involving immunotherapy and combinations with immunotherapy in thyroid neoplasms.
| Clinicaltrials.gov Identifier | Title | Phase | N | Population | Treatment Arms | Primary Endpoint |
|---|---|---|---|---|---|---|
| NCT03753919 (70) | A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma - The DUTHY Trial. | II | 46 |
- Cohort 1: Advanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary, follicular, Hürthle. Cell and poorly differentiated thyroid carcinoma (DTC). - Cohort 2: Advanced medullary thyroid carcinoma (MTC). - Cohort 3: Advanced anaplastic thyroid cancer (ATC). |
Durvalumab (1,500 mg) plus tremelimumab (75 mg) every 4 weeks up to 4 cycles followed by durvalumab (1500 mg) every 4 weeks. |
PFS at 6 months and OS at 6 months. |
| NCT04400474 (71) | Exploratory Basket Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. CABATEN Study. | II | 144 (all cohorts) | Cohort 2: Anaplastic thyroid cancer in first-line or after progression to chemotherapy or investigational drugs. | Cabozantinib (40 mg tablets, oral, once daily) + Atezolizumab (1,200 mg intravenously, every 3 weeks). |
ORR |
| NCT04560127 | A Single-arm, Non-randomized, Single-center Study to Evaluate Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer. | II | 10 | Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hürthle cells, poorly differentiated carcinoma). | Apatinib (250 mg PO QD) + Camrelizumab (200 mg, i.v., every 2 weeks). | PFS |
| NCT03914300 | Phase II Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab (CaboNivoIpi) in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer Whose Cancer Progressed After One Prior VEGFR-Targeted Therapy. | II | 24 | Radioactive iodine (RAI)-refractory/resistant papillary thyroid cancer (PTC), follicular thyroid cancer (FTC), or Hürthle cell thyroid cancer (HTC). The patient’s disease must have progressed on one line of VEGFR-targeted therapy (including, but not limited to, sorafenib, sunitinib, vandetanib, pazopanib, or lenvatinib) | Cabozantinib + Nivolumab + Ipilimumab. | ORR |
| NCT03215095 | Radioiodine (RAI) in Combination With Durvalumab (Medi4736) for RAI-avid, Recurrent/Metastatic Thyroid Cancers. | I | 11 | Thyroid carcinoma of follicular origin (papillary, follicular, Hürthle cell or poorly differentiated) and at least one RAI-avid lesion identified on the radioiodine scan. | Durvalumab (1,500 mg i.v. every 4 weeks) + Radioiodine (100 mCi). | DLT |
| NCT03122496 | A Pilot Study of Durvalumab (MEDI4736) With Tremelimumab in Combination With Image Guided Stereotactic Body Radiotherapy (SBRT) in the Treatment of Metastatic Anaplastic Thyroid Cancer. | I | 13 | Anaplastic thyroid cancer with clinical evidence of metastatic disease not curable by either surgery or radiation therapy | Durvalumab + Tremelimumab combined with SBRT (9Gy x 3 given within 2 weeks after the completion of cycle 1 of durvalumab and tremelimumab). | OS at 1 year |
| NCT03360890 | Synergy of Pembrolizumab Anti-PD-1 Immunotherapy With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors. The iPRIME Study. | II | 46 | Cohort B: Thyroid cancer, RAI-refractory and after failure, intolerance to or refusal of anti-antiangiogenic therapy, or with evidence of dedifferentiated or anaplastic histology. | Pembrolizumab (via i.v. at 200 mg every 3 weeks) + Docetaxel (via i.v. at 75 mg/m2 every 3 weeks for 3–6 cycles). | RR |
| NCT03246958 | A Phase 2 Study of Nivolumab Plus Ipilimumab in RAI Refractory, Aggressive Thyroid Cancer With Exploratory Cohorts in Medullary and Anaplastic Thyroid Cancer. | II | 53 | Metastatic, RAI refractory, differentiated thyroid cancer (including papillary and follicular thyroid cancer and poorly differentiated thyroid cancer), with progression within 13 months prior to study registration. | Ipilimumb + Nivolumab. | RR |
| NCT02973997 | Combination Targeted Therapy With Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers: A Phase II Study. | II | 60 | Locally recurrent and unresectable and/or distant metastatic DTC (including papillary and follicular thyroid cancer and poorly differentiated thyroid cancer) | Pembrolizumab + Lenvatinib. | Complete response rate |
| NCT04061980 | Encorafenib/Binimetinib With or Without Nivolumab for Patients With Metastatic BRAF V600 Mutant Thyroid Cancer. | II | 40 | Histologically (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC) | Arm I: Encorafenib + Binimetinib Arm II: Encorafenib + Binimetinib + Nivolumab. |
ORR |
| NCT04171622 | Lenvatinib in Combination With Pembrolizumab for Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer. | II | 25 | Unresectable or metastatic anaplastic thyroid carcinoma. Patients with a BRAFV600E mutation, who are unable to dabrafenib/trametinib, are eligible. | Pembrolizumab + Lenvatinib. | OS, PFS, and RR |
| NCT03181100 | Atezolizumab Combinations With Chemotherapy for Anaplastic and Poorly Differentiated Thyroid Carcinomas. | II | 50 | Unresectable or metastatic anaplastic thyroid or poorly differentiated thyroid carcinomas. |
Cohort I: Vemurafenib + Cobimetinib + Atezolizumab. Cohort II: Cobimetinib + Atezolizumab. Cohort III: Atezolizumab + Bevacizumab. Cohort IV: Paclitaxel or Nab-Paclitaxel + Atezolizumab. |
OS |
| NCT04675710 | Pembrolizumab in Combination With Dabrafenib and Trametinib as a Neoadjuvant Strategy Prior to Surgery in BRAF-Mutated Anaplastic Thyroid Cancer. | II | 30 | BRAFV600E mutation-positive anaplastic thyroid carcinoma surgically resectable. | Dabrafenib + Trametinib + Pembrolizumab. | Complete gross surgical resection (R0 or R1 resection) and OS |
N, number of patients expected to be enrolled; PFS, progression-free survival; ORR, overall response rate; DLT, dose-limiting toxicity; OS, overall survival; RR, response rate.