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

ConditionsAdvanced Cancer Clear Cell Renal Cell Carcinoma

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

177Lu girentuximab
Drug
Given by IV (vein)
Nivolumab
Drug
Given by IV (vein)
Cabozantinib
Drug
Given by PO
ArabinoFuranosylGuanine [18F]F-AraG
Drug
Given by IV (vein)

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: Cohort 1 (Biopsy)Experimental treatment 4 interventions

Group B: Cohort 2 (Biopsy)Experimental treatment 4 interventions

Group C: Cohort 3 (Biopsy)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

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 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Collaborator

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

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