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NCT04061980 · ClinicalTrials.gov registry record · Phase 2
Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer
A Phase 2 study of Metastatic Thyroid Gland Carcinoma and Refractory Thyroid Gland Carcinoma, sponsored by Providence Health & Services.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04061980: Active Phase 2 study of Metastatic Thyroid Gland Carcinoma and Refractory Thyroid Gland Carcinoma, sponsored by Providence Health & Services.
NCT04061980 is a Phase 2 study of Metastatic Thyroid Gland Carcinoma and Refractory Thyroid Gland Carcinoma that is active but no longer recruiting, run by Providence Health & Services. The registered enrollment target is 24 participants, below the 34-participant average among 5 other Metastatic Thyroid Gland Carcinoma trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04061980, a Phase 2 study of Metastatic Thyroid Gland Carcinoma and Refractory Thyroid Gland Carcinoma, is active but no longer recruiting, sponsored by Providence Health & Services.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well encorafenib and binimetinib given with or without nivolumab works in treating patients with BRAF V600 mutation positive thyroid cancer that has spread to other places in the body (metastatic) and does not respond to radioiodine treatment (refractory). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The trial aims to find out if the combination of encorafenib and binimetinib, with and without study nivolumab, is a safe and effective way to treat metastatic radioiodine refractory thyroid cancer.
Primary Outcome
ORR is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria. ORR at 6 months will be assessed using the efficacy evaluable analysis set. A point and 90% exact binomial confidence interval will be provided for each arm.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Binimetinib
- DRUG Encorafenib
Study Locations (1)
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-10-30 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 2 |
What the registry record for NCT04061980 still lists
NCT04061980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 34-participant average among 5 other Metastatic Thyroid Gland Carcinoma trials with a reported enrollment target (29% lower).
The record links to 7 conditions, with Metastatic Thyroid Gland Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT04061980 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04061980 about?
NCT04061980 is a clinical study titled "Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer". This phase II trial studies how well encorafenib and binimetinib given with or without nivolumab works in treating patients with BRAF V600 mutation positive thyroid cancer that has spread to other places in the body (metastatic) and does not respond to radioiodine treatment (refractory). Encorafenib...
What is the current status of trial NCT04061980?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-10-30. Estimated completion is 2027-01-30.
What conditions does trial NCT04061980 study?
This clinical trial studies the following conditions: Metastatic Thyroid Gland Carcinoma, Refractory Thyroid Gland Carcinoma, BRAF V600E Mutation Present, BRAF NP_004324.2:p.V600M, Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8.
What interventions are being tested in trial NCT04061980?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Binimetinib (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04061980?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04061980 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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