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Oligometastatic Renal Cell CarcinomaPhase 2NCT06004336

A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)

A Phase 2 study testing Pembrolizumab and Radiation therapy in people with Oligometastatic Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To learn if adding 1 year of therapy with pembrolizumab can help to continue to control RCC after radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oligometastatic Renal Cell Carcinoma
What is being tested?
Pembrolizumab and Radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteUnited States
Study dates
31 Oct 2023to 1 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 available for review at MD Anderson.
  • 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.
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  • 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 lesions are often equivocal.
  • 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 subjects. 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 subjects • 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 (ANC) ≥1500/µL --Platelets ≥100 000/µL --Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La --Renal --Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN Hepatic --Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN --AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
  • --Coagulation International normalized ratio (INR) OR prothrombin time (PT)
  • --Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
  • --ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase);
  • -- AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); ----GFR=glomerular filtration rate; ULN=upper limit of normal.
  • a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
  • b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.

Who cannot join

  • 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 RT if this therapy included immunotherapy (e.g. pembrolizumab, nivolumab, ipilimumab, etc.) or ≥4 weeks prior to initiation of the first dose of radiation if this systemic therapy did not include immunotherapy.
  • 2. Immunocompromising conditions, as follows:
  • Known acute or chronic human immunodeficiency virus (HIV) infection
  • History of primary immunodeficiency
  • History of allogeneic tissue/solid organ transplant
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  • 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 equivalent dose ≤10 mg of prednisone daily.
  • 3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and/or member of the study team.
  • 4. Patients with a prior history of grade 3 or worse immune-related adverse events attributed to checkpoint inhibitors (PD-1, PD-L1, or CTLA-4), except endocrine adverse events with appropriate hormone replacement.
  • 5. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • 6. Per the opinion of the treating physician of study team has cognitive impairments such that appropriate informed consent cannot be obtained or that he/she cannot participate in required study activities.
  • 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 active comparator/combination) plus 30 days (a menstruation cycle) after the last dose of study treatment.
  • 3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chad Tang, MD contact

(713) 745-7179

ctang1@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Chad Tang, MD, 713-745-7179, ctang1@mdanderson.org

    Chad Tang, MD

    Recruiting

Other trials in United States

About this study

To learn if adding 1 year of therapy with pembrolizumab can help to continue to control RCC after radiation therapy.

Read the detailed description

Primary Objectives:

  • To evaluate PFS in patients randomized to definitive RT followed by pembrolizumab versus definitive RT followed by observation.

Secondary Objectives:

Secondary Objective #1:

  • To evaluate overall survival (OS) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation.

Secondary Objective #2:

  • To evaluate time to next line systemic therapy (defined as systemic therapy given after pembrolizumab) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation.

Secondary Objective #3:

  • To evaluate local recurrence free survival (LRFS) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation.

Secondary Objective #4:

  • To evaluate distant recurrence free survival (DRFS) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation.

Secondary Objective #5:

  • To evaluate estimate PFS2, LRFS2, and DRFS2 in patients who crossed over from one randomization arm to the other arm.

Secondary Objective #6:

  • To evaluate frequency of adverse events (AEs) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation.

Exploratory Objectives:

Exploratory Objective #1:

  • To determine the association of translational biomarkers including peripheral blood markers and tissue markers with patient outcomes.

Exploratory Objective #2:

  • To determine changes in translational biomarkers including peripheral blood markers and tissue markers after receipt of definitive RT.

Exploratory Objective #3:

-To estimate PFS2, LRFS2, and DRFS2 in patients who crossed over from one randomization arm to the other arm.

Being tested
Pembrolizumab, Radiation therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Given by vein (IV)

  • Radiation therapyRadiation

    Given by vein (IV)

Study groups in NCT06004336
Study groupRoleWhat they receive
Radiation therapy (Control Arm)ExperimentalParticipants will be asked to receive radiation therapy and be randomly assigned to receive pembrolizumab or not after that.
Receives: Drug: Pembrolizumab; Radiation: Radiation therapy
Radiation Therapy and PembrolizumabExperimentalParticipants will be asked to receive radiation therapy and be randomly assigned to receive pembrolizumab or not after that.
Receives: Drug: Pembrolizumab; Radiation: Radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: through study completion; an average of 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start31 Oct 2023
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004336
Sponsor's protocol ID
2023-0006
Other IDs
NCI-2023-06314
Status last verified
Jul 2026
First submitted
15 Aug 2023
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Radiation therapy in people with Oligometastatic Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chad Tang, MD ((713) 745-7179, ctang1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06004336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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