CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
Vemurafenib +2 moredrug
Likely dose
Vemurafenib 960 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04462471
NCT04462471Phase 1Completed
CompareCT.gov

A Phase Ib Trial of Vemurafenib Plus Copanlisib to Enhance Radioiodine Avidity in Radioiodine-Refractory Thyroid Cancers

Memorial Sloan Kettering Cancer Center·interventional·Posted Jul 8, 2020·Updated Sep 8, 2025

In Brief

A Phase 1 clinical trial evaluating I-124 PET/CT lesion dosimetry, Vemurafenib, and 1 other intervention for Thyroid Carcinoma and 5 related conditions. Completed, enrolled 8 participants across 7 sites.

Detailed Summary

The purpose of this study is to develop a new drug treatment to reverse tumor resistance to radioiodine in BRAF mutant tumors so that radioiodine can be given to shrink tumors. This study is also being done to find out the highest doses of copanlisib and vemurafenib that, when given in combination, do not cause serious side effects, and whether the study treatment will make radioiodine therapy work better in patients with BRAF-mutant thyroid cancers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Carcinoma, Thyroid Cancer, Thyroid Cancer, Follicular, Thyroid Cancer (Follicular Cell), Thyroid Cancer, Papillary, BRAF V600E Mutation Positive
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 8, 2020
Enrollment StartJun 26, 2020
Primary CompletionSep 29, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.0 years ago

Interventions

I-124 PET/CT lesion dosimetryother

I-124 PET/CT scans will be performed during this process to quantify baseline RAI avidity in index metastatic lesion(s)

Vemurafenibdrug

Dose level 1 \& 2: 960 mg PO bid Dose level -1: 720 mg PO bid Dose level -2: 480 mg PO bid

Copanlisibdrug

Dose level 2: 60 mg IV weekly Dose level 1, -1, -2: 45 mg IV weekly