Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).

Eligibility criteria

Qualifiers

Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515

Age ≥ 18 years

Has locally advanced or metastatic RCC with predominantly clear cell subtype

Has at least one measurable lesion as defined by RECIST version 1.1

Disqualifiers

Has received treatment with any frontline systemic therapy for metastatic RCC

Has a history of leptomeningeal disease or spinal cord compression

Has a history of autoimmune disease requiring active therapy

Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND

Trial design

Treatments tested in this trial

  • 177Lu girentuximab
  • Nivolumab
  • Cabozantinib
  • ArabinoFuranosylGuanine [18F]F-AraG

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Collaborator

United States Department of Defense

Collaborator