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Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers

NCT04462471 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-09-08

Study results available
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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.

Conditions

  • Thyroid Carcinoma
  • Thyroid Cancer
  • Thyroid Cancer, Follicular
  • Thyroid Cancer (Follicular Cell)
  • Thyroid Cancer, Papillary
  • BRAF V600E Mutation Positive

Interventions

DIAGNOSTIC_TEST

I-124 PET/CT lesion dosimetry

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

DRUG

Vemurafenib

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

DRUG

Copanlisib

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

Sponsors & Collaborators

Principal Investigators

  • Alan L Ho, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2023-09-29
Completion
2023-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462471 on ClinicalTrials.gov