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New treatment option for Oligometastatic Renal Cell Carcinoma
Official title A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)
ClinicalTrials.gov ID: NCT06004336
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oligometastatic renal cell carcinoma.
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
- To learn if adding 1 year of therapy with pembrolizumab can help to continue to control RCC after radiation therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- In order to be eligible for trial participation, patients must have:
- The participant provides written informed consent for the trial.
- Pathologically confirmed diagnosis of RCC with a clear cell component.
- Be willing and able to undergo biopsy of a lesion planned for definitive RT. If a lesion amenable to SBRT was biopsied prior to enrollment, this...
- Patients may be allowed on this trial without a biopsy if they are deemed medically unfit for biopsy or if the biopsy poses undue risk in the opinion...
You likely can't join if
- The patient must be excluded from participating in the trial based on the following conditions: 1\. The patient must have received their last dose of...
- Known acute or chronic human immunodeficiency virus (HIV) infection
- History of primary immunodeficiency
- History of allogeneic tissue/solid organ transplant
- Current or prior use of immunosuppressive medication within 7 days before the first dose of study treatment, except for topical, ocular, intranasal...
- Diffuse metastatic processes including leptomeningeal disease, diffuse bone marrow involvement, and peritoneal carcinomatous, which by the discretion...
See the full eligibility criteria
- In order to be eligible for trial participation, patients must have:
- The participant provides written informed consent for the trial.
- Pathologically confirmed diagnosis of RCC with a clear cell component.
- Be willing and able to undergo biopsy of a lesion planned for definitive RT. If a lesion amenable to SBRT was biopsied prior to enrollment, this material can be used in lieu of a planned biopsy if the tissue is...
- Patients may be allowed on this trial without a biopsy if they are deemed medically unfit for biopsy or if the biopsy poses undue risk in the opinion of the treating physician(s).
- Be ≥18 years of age on the day of signing informed consent.
- ECOG performance status 0-1. NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is ambulatory for the purpose of assessing their performance status.
- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Oligometastatic RCC patients (≤5 metastatic lesions at the time of study entry). Per the discretion of the treating clinicians, we will not count lung lesions \<1 cm short axis and LNs \<1.5 cm short axis as these...
- CNS disease will be allowed and the number of CNS lesions counted towards the number of metastatic lesions for the purposes of study entry.
- Demonstrate adequate organ function as defined in the table below, all screening labs should be performed within 10 days prior to enrollment.
- At least one site, which in the opinion of the treating radiation oncologist, is treatable with definitive RT and can be biopsied.
- Criteria for known Hepatitis B and C positive people. Hepatitis B and C screening tests are not required unless: Known history of HBV or HCV infection
- As mandated by local health authority
- Hepatitis B positive people Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
- Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
- Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization. Table Adequate Organ Function Laboratory Values System Laboratory Value --Hematological --Absolute neutrophil count...
- The patient must be excluded from participating in the trial based on the following conditions: 1\. The patient must have received their last dose of systemic therapy ≥24 weeks prior to initiation of their first dose of...
- Known acute or chronic human immunodeficiency virus (HIV) infection
- History of primary immunodeficiency
- History of allogeneic tissue/solid organ transplant
- Current or prior use of immunosuppressive medication within 7 days before the first dose of study treatment, except for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an...
- Diffuse metastatic processes including leptomeningeal disease, diffuse bone marrow involvement, and peritoneal carcinomatous, which by the discretion of the treating physician cannot be treated definitively.
- Is pregnant, breast feeding, or expecting to conceive within the projected duration of the trial at the screening visit and at least one of the following conditions apply.
- Not a woman of childbearing potential (WOCBP) as defined in Appendix OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatment(s) (pembrolizumab and/or any...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, 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 - 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?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.