Study of Nivolumab in Combination With 177Lu-girentuximab for Kidney Cancer

Conditions

• Advanced Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Kidney Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 177Lu-labeled-girentuximab — DRUG
  The initial starting dose/Dose Level 1 of 177Lu-labeled-girentuximab is 1804 MBq/m2. if 0/3 or 1/6 DLTs, participants will be treated at Dose Level 2 177Lu-girentuximab 2405 MBq/m2. \>/= 2/6 DLTs, Dose Level -1 is 177Lu-girentuximab 1353 MBq/m2 Once the MTD is established, a Simon two-stage optimal design will commence.
• Nivolumab — DRUG
  Nivolumab 240mg q2wk
• 89Zr-girentuximab PET/CT — DIAGNOSTIC_TEST
  All patients will undergo a 89Zr-girentuximab PET/CT scan prior to every 177Lu-girentuximab administration
• 177Lu whole body (WB) planar and SPECT/CT scans — DIAGNOSTIC_TEST
  177Lu whole body (WB) planar and SPECT/CT scans will be performed after each administration of 177Lu-girentuximab

Study Details

The purpose of this study is to see if the combination of 177Lu-girentuximab and nivolumab is a safe and effective treatment for advanced clear cell renal cell carcinoma/ccRCC that has the CAIX protein.

Key Dates

First listed

Feb 15, 2022

Start date

Feb 16, 2022

Status verified

Jan 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

9 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Safety lead-in Phase: Participants with Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC
  Participants have Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC. The protocol will start with a safety-lead in phase using a 3+3 design to establish the maximal tolerated dose (MTD) of 177Lu-labeled-girentuximab in combination with standard-dose nivolumab. The initial starting dose of 177Lu-labeled-girentuximab is 1804 MBq/m2 which is 75% of the single agent dose established in prior studies and will proceed as shown in the schema below. Once the MTD is established, a Simon two-stage optimal design will commence. 10 patients will be enrolled in the first stage and if no responses are observed, the study will be terminated. If 1 or more responses are observed in the first 10 patients, we will extend enrollment to a total of 29 patients (19 additional patients) in the second stage.
• Experimental: Phase 2 Participants
  Participants have Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC. If 1 or more responses are observed in the first 10 patients, we will extend enrollment to a total of 29 patients (19 additional patients) in the second stage.

Primary Outcome Measure

Maximal tolerated dose (MTD) of 177Lu-girentuximab [ Time Frame: 24 (+/- 2) weeks ]

Locations (7)

Find similar trials in Basking Ridge, NJ

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