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

Conditions

• Oligometastatic Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Given by vein (IV)
• Radiation therapy — RADIATION
  Given by vein (IV)

Study Details

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

Key Dates

Start date

Oct 31, 2023

Status verified

Jan 2026

Primary completion

Jan 1, 2029

Completion

Jan 1, 2029

Study Design

Enrollment

144 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Radiation therapy (Control Arm)
  Participants will be asked to receive radiation therapy and be randomly assigned to receive pembrolizumab or not after that.
• Experimental: Radiation Therapy and Pembrolizumab
  Participants will be asked to receive radiation therapy and be randomly assigned to receive pembrolizumab or not after that.

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. ]

Central Contacts

• Chad Tang, MD
  (713) 745-7179
  [email protected]

Locations (1)

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