Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naïve Metastatic Uveal Melanoma
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|ClinicalTrials.gov Identifier: NCT05308901|
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : August 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Melanoma, Uveal||Drug: Pembrolizumab Drug: Lenvatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial Evaluating The Combination Of Lenvatinib Plus Pembrolizumab In Patients With Treatment Naive Metastatic Uveal Melanoma|
|Actual Study Start Date :||August 2, 2022|
|Estimated Primary Completion Date :||June 1, 2024|
|Estimated Study Completion Date :||June 1, 2026|
Experimental: Pembrolizumab + Lenvatinib
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
200 mg IV every 3 weeks for a maximum of 2 years.
Other Name: Keytruda
20 mg daily for a maximum of 2 years.
- Evaluate the effect of lenvatinib plus pembrolizumab on progression free survival [ Time Frame: 12 weeks post treatment discontinuation ]progression free survival, defined as the time from enrollment to the first documented evidence of disease progression or death.
- Evaluate the objective response rate resulting from treatment with lenvatinib plus pembrolizumab [ Time Frame: 6 weeks after treatment discontinuation ]Objective response rate (complete and partial responses assessed by iRECIST)
- Evaluate the effect of treatment with lenvatinib plus pembrolizumab on overall survival [ Time Frame: 12 weeks post treatment discontinuation ]Overall survival, defined as the time from enrollment to death (resulting from any cause).
- Evaluate the safety and tolerability of treatment with lenvatinib plus pembrolizumab in patients with metastatic uveal melanoma [ Time Frame: 30 days after last treatment dose ]Adverse events (per CTCAE v5.0), frequency of treatment information, dose reduction, and treatment discontinuation due to treatment related adverse events (TRAE).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308901
|Contact: Chris Fountain, RNemail@example.com|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Chris Fountain, RN|
|Principal Investigator: Matthew Taylor, MD|
|Principal Investigator:||Matthew Taylor, MD||Providence Health & Services|