Metastatic Renal Cell Carcinoma study: IMSA101
Official title Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
ClinicalTrials.gov ID: NCT06601296
What this study is testing
What is IMSA101?
IMSA101 is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for metastatic renal cell carcinoma ( mrcc).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding a special immune‑boosting drug and targeted radiation helps control kidney cancer that has spread.
- Who it's for
- You may be able to join if you have kidney cancer that has spread and only a few spots are getting worse.
- What's involved
- You would keep taking a maintenance medicine called Nivolumab. You would also receive a new drug called IMSA101 that wakes up the immune system, and you would get precise radiation to the few growing spots. You will have doctor visits and tests to see how you do.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have metastatic ccRCC.
- Patients must have oligoprogressive disease (up to 5 progressing lesions) on any ongoing or prior check-point inhibitor regimen that are all amenable...
- Karnofsky Performance Status (KPS) of at least 50%.
- Life expectancy of at least 6 months.
- Age ≥ 18 years.
You likely can't join if
- Prior high-grade toxicity from check-point inhibitors deemed to place he patient at high risk for toxicity recurrence with re-challenge with...
- Prior STING agonist use.
- Any condition requiring systemic treatment with corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within...
- Uncontrolled adrenal insufficiency.
See the full eligibility criteria
- Patients must have metastatic ccRCC.
- Patients must have oligoprogressive disease (up to 5 progressing lesions) on any ongoing or prior check-point inhibitor regimen that are all amenable to radiation including one lesion suitable for IMSA101 injection.
- Karnofsky Performance Status (KPS) of at least 50%.
- Life expectancy of at least 6 months.
- Age ≥ 18 years.
- Patients must have adequate organ and marrow function within 14 days prior to study entry.
- All IMDC risk categories are allowed.
- Prior high-grade toxicity from check-point inhibitors deemed to place he patient at high risk for toxicity recurrence with re-challenge with check-point inhibitors.
- Prior STING agonist use.
- Any condition requiring systemic treatment with corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug.
- Uncontrolled adrenal insufficiency.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.