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NCT03793166 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
1,175
Enrollment target
20
Study locations

NCT03793166 is a Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 1,175 participants, above the 177-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (564% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT03793166, a Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,175 participants
Enrollment target
20
Study locations

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 Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Bone Scan
  • DRUG Cabozantinib
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

Arkansas

  • Highlands Oncology Group - Fayetteville - Fayetteville
  • Mercy Hospital Fort Smith - Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • Highlands Oncology Group - Rogers - Rogers
  • Highlands Oncology Group - Springdale

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • PCR Oncology - Arroyo Grande

Arizona

  • Kingman Regional Medical Center - Kingman
  • Cancer Center at Saint Joseph's - Phoenix

Alabama

  • University of South Alabama Mitchell Cancer Institute - Mobile

Trial Details

FieldValue
Enrollment Target 1,175 participants
Start Date 2019-06-07
Est. Completion 2028-01-25
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03793166

The ClinicalTrials.gov registry entry for NCT03793166 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,175 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 177-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (564% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03793166 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, Arkansas, California.

Frequently Asked Questions

What is clinical trial NCT03793166 about?

NCT03793166 is a clinical study titled "Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study". 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 ...

What is the current status of trial NCT03793166?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,175 participants. The study started on 2019-06-07. Estimated completion is 2028-01-25.

What conditions does trial NCT03793166 study?

This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Metastatic Malignant Neoplasm in the Bone, Stage III Renal Cell Cancer AJCC v8, Metastatic Malignant Neoplasm in the Lymph Nodes.

What interventions are being tested in trial NCT03793166?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Cabozantinib (DRUG), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03793166?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03793166 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.