Nivolumab Plus Ipilimumab in Thyroid Cancer

Phase 2 Completed 53 enrolled Dana-Farber Cancer Institute Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This research study is studying nivolumab, an investigational drug, in combination with ipilimumab, also an investigational drug, as a possible treatment for thyroid cancer. The drugs involved in this study are: * Nivolumab (Opdivo™) * Ipilimumab (Yervoy™)

Timeline

Start: 2017-10-03
Primary completion: 2021-01-21
Completion: 2021-07-31

Outcome

Missed primary endpoint

paper The study did not meet its end point in the primary population of RAIR DTC and does not support further investigation in non-biomarker-selected DTC. PMID 39446365 ↗

Publications

Sehgal K, Pappa T, Shin KY, Schiantarelli J, Liu M, Ricker C, Besson NR, Jones SM, Welsh EL, Pfaff KL, Barletta JA, Park J, Reardon B, Doherty GM, Alexander EK, Rodig SJ, Barbie DA, O'Neill A, Van Allen E, Haddad RI, Lorch JH. Dual Immune Checkpoint Inhibition in Patients With Aggressive Thyroid Carcinoma: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2024 Dec 1;10(12):1663-1671. doi: 10.1001/jamaoncol.2024.4019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous