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NCT04171622 · ClinicalTrials.gov registry record · Phase 2
Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer
A Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Metastatic Thyroid Gland Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04171622: Active Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Metastatic Thyroid Gland Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04171622 is a Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Metastatic Thyroid Gland Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 29-participant average among 6 other Poorly Differentiated Thyroid Gland Carcinoma trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04171622, a Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Metastatic Thyroid Gland Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well lenvatinib and pembrolizumab work in treating patients with anaplastic thyroid cancer that is stage IVB and has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable), or stage IVC that has spread to other places in the body (metastatic). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Given lenvatinib and pembrolizumab may work better than giving either one alone in treating stage IVB or C anaplastic thyroid cancer.
Primary Outcome
Kaplan-Meier method will be used to estimate the overall survival distribution. 95% confidence intervals for median and probabilities will be computed.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lenvatinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-11-04 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
What the registry record for NCT04171622 still lists
NCT04171622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 29-participant average among 6 other Poorly Differentiated Thyroid Gland Carcinoma trials with a reported enrollment target (14% lower).
The record links to 6 conditions, with Poorly Differentiated Thyroid Gland Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04171622 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04171622 about?
NCT04171622 is a clinical study titled "Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer". This phase II trial studies how well lenvatinib and pembrolizumab work in treating patients with anaplastic thyroid cancer that is stage IVB and has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable), or stage IVC that has spread to other places...
What is the current status of trial NCT04171622?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2021-11-04. Estimated completion is 2027-08-31.
What conditions does trial NCT04171622 study?
This clinical trial studies the following conditions: Poorly Differentiated Thyroid Gland Carcinoma, Metastatic Thyroid Gland Carcinoma, Unresectable Thyroid Gland Carcinoma, Thyroid Gland Squamous Cell Carcinoma, Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8.
What interventions are being tested in trial NCT04171622?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT04171622?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04171622 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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