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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05155033
The ClinicalTrials.gov registry entry for NCT05155033 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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