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NCT05155033 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
A Phase 2 study of Metastatic Melanoma and Metastatic Renal Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT05155033: Recruiting Phase 2 study of Metastatic Melanoma and Metastatic Renal Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05155033 is a Phase 2 study of Metastatic Melanoma and Metastatic Renal Cell Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 78 participants, roughly in line with the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155033, a Phase 2 study of Metastatic Melanoma and Metastatic Renal Cell Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma. Researchers want to see if these drugs can be used together to produce better results in people with these types of cancer. Objective: To learn if the combination of pembrolizumab and aldesleukin can be used to treat metastatic or advanced melanoma and renal cell cancer. Eligibility: Adults aged 18 years or older who have metastatic or advanced melanoma or renal cell carcinoma. Design: Participants will be screened with: * Medical history * Physical exam * Electrocardiogram * Blood and urine tests * Ability to perform tasks of daily living * Imaging scans (CT, MRI, PET, and/or X-rays). They may get a contrast agent to enhance the images. * Photographs, if needed Some of these tests will be repeated during the study. Participants will receive the study drugs by IV (a plastic tube that is put into a vein) for 4 days. A second cycle of treatment will be given 21 days later. They will stay in the hospital for each of the cycles in the first course of treatment. After 2 months, their cancer will be evaluated. They may receive a second course of pembrolizumab alone on Days 1 and 21. They will not have to stay in the hospital for this course. About 30 days after treatment ends, participants will have a safety follow-up visit. Then they will have visits every 3 months for up to 1 year, and then every 6 months for up to 4 years. Follow-up can also be done by phone, email, and mail. If their cancer gets worse, they will stop having visits. Participation will last for 5 years.
Primary Outcome
Determine the rate of objective response (using RECIST v1.1 criteria)
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Aldesleukin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2022-08-18 |
| Est. Completion | 2031-09-01 |
| Phase | Phase 2 |
What NCT05155033 shows while recruiting
NCT05155033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, roughly in line with the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target.
The record links to 4 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05155033 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05155033 about?
NCT05155033 is a clinical study titled "Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma". Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma. Researchers want to see if these drugs can be used together to produce better results in people with these types of cancer. Objective: ...
What is the current status of trial NCT05155033?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2022-08-18. Estimated completion is 2031-09-01.
What conditions does trial NCT05155033 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Advanced Locoregional Melanoma, Clear Cell Histology.
What interventions are being tested in trial NCT05155033?
The interventions under investigation include: Pembrolizumab (DRUG), Aldesleukin (DRUG).
Who is sponsoring clinical trial NCT05155033?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05155033 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05155033's enrollment target sits among peer trials
78 22nd of 91 higher than 70 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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