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Clinical Trials in Mexico / NCT03793166
Active, not recruiting Phase 3

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

NCT03793166 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2019-06-07
Last updated
2026-08-31

Condition(s) studied

Clear Cell Renal Cell CarcinomaMetastatic Malignant Neoplasm in the BoneMetastatic Malignant Neoplasm in the Lymph NodesMetastatic Malignant Neoplasm in the Soft TissueMetastatic Malignant Neoplasm in the VisceraRhabdoid Tumor of the KidneySarcomatoid Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8

Investigational drug(s) / intervention(s)

Biospecimen CollectionBone ScanCabozantinib →Computed TomographyIpilimumab →Magnetic Resonance ImagingNivolumab →Quality-of-Life AssessmentQuestionnaire Administration

Biospecimen Collection: Undergo blood and urine sample collection

Bone Scan: Undergo bone scan

Cabozantinib: Given PO

Computed Tomography: Undergo CT scan

Ipilimumab: Given IV

Magnetic Resonance Imaging: Undergo MRI

Nivolumab: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * STEP I REGISTRATION CRITERIA * Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid or rhabdoid features * Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1 * Measurable disease as defined in the protocol * Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria (1 or more of the following): Karnofsky performance status \[KPS\] \< 80, \< 1 year from diagnosis \[including initial nephrectomy\] to systemic treatment for metastatic disease, hemoglobin less than lower limit of normal \[LLN\], corrected calcium concentration greater than upper limit of normal \[ULN\], absolute neutrophil count greater than ULN, platelet count \> ULN) * Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment * Karnofsky performance status \>= 70% * No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as \> 1 year since completion of systemic therapy * No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 \[\>28 days\]. Prior adjuvant sunitinib \>180 days since completion and prior immunotherapy as above are allowed). * No systemic cancer therapy less than 28 days prior to registration; no radiation therapy less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\< 14 days prior to registration is required * Age \>= 18 years * None of the following: * Active autoimmune disease requiring ongoing therapy * Ongoing acute toxicity \> grade 2 from previous treatment * History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies * Active hepatitis B/C, or active tuberculosis (purified protein derivative \[PPD\] response without active tuberculosis \[TB\] is allowed) * HIV-infected patients with detectable viral load within 6 months prior to registration. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible * Concurrent use of immunosuppressive medication including prednisone above 10 mg daily * Uncontrolled adrenal insufficiency * Uncontrolled hypertension (systolic blood pressure \[BP\] \> 150mmHg or diastolic BP \> 90mmHg) * Major surgery less than 28 days prior to registration * Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to registration * Any arterial thrombotic events within 180 days prior to registration * Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to registration * Cavitating pulmonary lesions or known endotracheal or endobronchial disease manifestations * Lesions encasing or invading any major blood vessels (this does not include tumor thrombus extending into/through renal vein/inferior vena cava \[IVC\]). Patients with tumor thrombus extending into/through renal vein are considered eligible * Moderate of severe hepatic impairment (child-Pugh B or C) * Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180 days prior to registration. (Any asymptomatic, treated pulmonary embolism or asymptomatic, treated deep venous thrombosis \> 30 days prior to registration allowed) * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms * Unstable cardiac arrhythmia within 6 months prior to registration * Any gastrointestinal (GI) bleeding =\< 180 days, hemoptysis, or other signs of pulmonary hemorrhage =\< 90 days prior to registration * History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration * Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome within 28 days prior to registration * Untreated hypothyroidism (treated hypothyroidism on thyroid replacement therapy is allowed. Abnormal thyroid-stimulating hormone \[TSH\] is acceptable with normal T3/free T4 if treated on thyroid replacement therapy) * Evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome * Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration Allowed anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Allowed also in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor * Significant cardiac ischemia events (ST elevation myocardial infarction \[STEMI\] or non-ST-elevation myocardial infarction \[NSTEMI\]) within 6 months or active New York (NY) Heart Association class 3-4 heart failure symptoms * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 8 g/dL * Calculated (Calc.) creatinine clearance \>= 30 mL/min * Urine protein =\< 1+ or urine protein to creatinine (UPC) ratio \< 1 * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except for patients with known or likely Gilbert's syndrome, for whom total bilirubin up to 3 mg/dL is allowed with direct bilirubin =\< 20% total bilirubin) * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =\< 2.5 x upper limit of normal (ULN) or \< 5 x ULN if hepatic metastases present * STEP 2 REGISTRATION ELIGIBILITY CRITERIA * Successful completion of at least 1 cycle of ipilimumab/nivolumab * Resolution of any treatment-related adverse events to grade 1 or less per dose modification section (this criteria does not include any adverse events \[AEs\] not attributable to treatment which are present due to disease), with prednisone-equivalent dosing at 10 mg daily or less. Exceptions for this criteria include patients receiving replacement hormone treatments (such as levothyroxine for treatment-related hypothyroidism or glucocorticoid replacement for adrenal insufficiency). Please contact study chair if further discussion is needed * No more than 80 days from last dose of ipilimumab/nivolumab

Primary outcome measure(s)

Trial sites (859)

FacilityCityRegionStatus
University of South Alabama Mitchell Cancer Institute Mobile Alabama
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
Kingman Regional Medical Center Kingman Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Highlands Oncology Group - Fayetteville Fayetteville Arkansas
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
Highlands Oncology Group - Rogers Rogers Arkansas
Highlands Oncology Group Springdale Arkansas
Kaiser Permanente-Anaheim Anaheim California
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
PCR Oncology Arroyo Grande California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Bellflower Bellflower California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Community Cancer Institute Clovis California
University Oncology Associates Clovis California
Kaiser Permanente-Fontana Fontana California
Kaiser Permanente South Bay Harbor City California
Kaiser Permanente-Irvine Irvine California
UC San Diego Moores Cancer Center La Jolla California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Kaiser Permanente West Los Angeles Los Angeles California
Kaiser Permanente-Ontario Ontario California
Kaiser Permanente - Panorama City Panorama City California
Kaiser Permanente-Riverside Riverside California
University of California Davis Comprehensive Cancer Center Sacramento California
Kaiser Permanente-Rio San Diego San Diego California
Kaiser Permanente-San Diego Zion San Diego California
Sharp Memorial Hospital San Diego California
Naval Medical Center -San Diego San Diego California
UCSF Medical Center-Mission Bay San Francisco California

+ 819 more sites — see the full list on the official registry below.

On this site

📄 Cabometyx (cabozantinib) drug profile → 📄 Opdivo (nivolumab) drug profile →

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03793166 on ClinicalTrials.gov ↗ ← All trials in Mexico