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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05663710
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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

Key Dates

Start date
Jun 30, 2023
Status verified
Apr 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (Biopsy)
    Participants within 2 weeks of starting the first dose of 177Lu-girentuximab
  • Experimental: Cohort 2 (Biopsy)
    Participants within 2 weeks of Cycle 4
  • Experimental: Cohort 3 (Biopsy)
    Participants at the time of progression or at 20 months post treatment

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 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Eric Jonasch, MD
[email protected]
713-563-7232
Eric Jonasch, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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