Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03793166 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT03793166 · ClinicalTrials.gov record · last posted 2026-08-04

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

StatusActive, Not Recruiting
PhasePhase 3
Started2019-06-07
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 764 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 764 times since 2019-01-03; most recent amendment 2026-07-01. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-05-16
Status change RecruitingActive, Not Recruitingv683
2021-03-31
Status change SuspendedRecruitingv225
2021-03-11
Status change RecruitingSuspendedv221
2019-05-17
Status change Not Yet RecruitingRecruitingv4
Trial Details
NCT Number NCT03793166
Lead Sponsor National Cancer Institute (NCI)
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 +1 more
Enrollment 1,175 participants
Start Date 2019-06-07
Primary Completion 2028-01-25 (estimated)
Study Completion 2028-01-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-04