Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study

Summary

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

Conditions

• Clear Cell Renal Cell Carcinoma
• Metastatic Malignant Neoplasm in the Bone
• Metastatic Malignant Neoplasm in the Lymph Nodes
• Metastatic Malignant Neoplasm in the Soft Tissue
• Metastatic Malignant Neoplasm in the Viscera
• Rhabdoid Tumor of the Kidney
• Sarcomatoid Renal Cell Carcinoma
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Cabozantinib

Given PO

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Tian Zhang · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-07

Primary Completion

2028-01-25

Completion

2028-01-25

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations