This is a randomized, double-blind, controlled trial to evaluate the efficacyand safety of cabozantinib in combination with nivolumab and ipilimumabversus nivolumab and ipilimumab in previously untreated subjects withintermediate- and poor-risk advanced or metastatic RCC

Phase 1

• Conditions: Metastatic Renal Cell Carcinoma; MedDRA version: 21.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004567-31-IT
• Lead Sponsor: EXELIXIS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

- Histologically confirmed advanced (not amenable to curative surgery or
radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma
with a clear-cell component.
- Intermediate- or poor-risk RCC as defined by International Metastatic
RCC Database Consortium (IMDC) criteria.
- Measurable disease per RECIST 1.1 as determined by the Investigator.
- Karnofsky Performance Status (KPS) = 70%.
- Adequate organ and marrow function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 418
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 258

Exclusion Criteria

- Prior systemic therapy for unresectable locally advanced or metastatic
RCC including investigational agents.
- Uncontrolled, significant intercurrent or recent illness including, but
not limited to serious cardiovascular disorders (including uncontrolled
hypertension defined as sustained blood pressure (BP) > 150 mm Hg
systolic or > 90 mm Hg diastolic despite optimal antihypertensive
treatment), GI disorders associated with high risk for perforation or
fistula formation, tumors invading GI tract, bowel obstruction, intraabdominal
abscess, clinically significant bleeding events, cavitating
pulmonary lesions, or lesion invading major pulmonary blood vessels.
-Other clinically significant disorders such as:
i. Any active, known or suspected autoimmune disease.
ii. Any condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednisone equivalent) or other
immunosuppressive medications within 14 days of randomization.
iii. Active infection requiring systemic treatment. Acute or chronic
hepatitis B or C infection, known human immunodeficiency virus (HIV)
or acquired
immunodeficiency syndrome (AIDS)-related illness, or known positive
test for tuberculosis infection.
-Major surgery (eg, GI surgery, removal or biopsy of brain metastasis)
within 8 weeks prior to randomization. Prior laparoscopic nephrectomy
within 4 weeks prior to randomization. Minor surgeries within 10 days
prior to randomization. Subjects must have complete wound healing
from major surgery or minor surgery before randomization.
- Any other active malignancy at time of randomization or diagnosis of
another malignancy within 3 years prior to randomization that requires
active treatment, except for locally curable cancers that have been
apparently cured, such as basal or squamous cell skin cancer, superficial
bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified