Cabozantinib In Combo With NIVO + IPI In Advanced NCCRCC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Bradley A. McGregor, MD
Study ID
NCT04413123
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chromophobe Renal Cell Carcinoma
  • Collecting Duct Renal Cell Carcinoma
  • Metastatic Ncc Renal Cell Carcinoma
  • Papillary Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Translocation Renal Cell Carcinoma
  • Unclassified Renal Cell Carcinoma
  • Unresectable Advanced Renal Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Cabozantinib predetermined protocol dosage po daily
  • Nivolumab — DRUG
    Nivolumab predetermined protocol dosage via IV every 3 weeks
  • Ipilimumab — DRUG
    Ipilimumab predetermined protocol dosage via IV every 3 weeks

Study Details

This research study will assess whether cabozantinib, nivolumab and ipilimumab in combination are safe and effective in slowing down the growth of kidney cancer(renal cell carcinoma or RCC) that has advanced or spread to other areas the body.

Key Dates

First listed
Jun 2, 2020
Start date
Nov 5, 2020
Status verified
Jan 2026
Primary completion
Dec 20, 2026
Completion
Jun 20, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Eligible patients will be enrolled and receive treatment with * Cycle 1-4 (cycles of 21 days) * Cabozantinib predetermined protocol dosage po daily * Nivolumab predetermined protocol dosage via IV every 3 weeks * Ipilimumab predetermined protocol dosage via IV every 3 weeks * After the first four cycles of therapy, * Cabozantinib determined protocol dosage po daily * Nivolumab predetermined protocol dosage via IV every 3 weeks (cycles of 28 days)

Primary Outcome Measure

Overall Response Rate [ Time Frame: tart of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started up to 21 Months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Brigham & Woman's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
UT Southwestern MedicalDallasTexas75390-

Find similar trials in Boston, MA

Nationwide
Kidney cancer trialsOncology trialsUrology trials
By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham & Woman's Hospital· Boston, MADana Farber Cancer Institute· Boston, MAUT Southwestern Medical· Dallas, TX

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