Active, not recruitingNCT03793166Updated Oct 1, 2026

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

A Phase 3 interventional study of Biospecimen Collection and Bone Scan in Clear Cell Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lymph Nodes, sponsored by National Cancer Institute (NCI). Active, not recruiting at 859 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

Updated Oct 1, 20261 site added1 site removedGo to Updates ↓

Phase: Phase 3
Study type: Interventional
Enrollment: 1,175
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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.

Read the detailed description

PRIMARY OBJECTIVE:

I. To compare the overall survival (OS) in patients with metastatic renal cell cancer (RCC) treated with ipilimumab-nivolumab followed by either nivolumab versus cabozantinib-nivolumab.

SECONDARY OBJECTIVES:

I. To determine progression free survival (PFS) of patients treated with nivolumab versus nivolumab-cabozantinib.

II. To evaluate the 12-month complete response rate in patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have complete response [CR] and relapse before 12 months will not be counted as a CR at 12-months).

III. To evaluate the rates of discontinuing therapy at 1 year. IV. To compare objective response rates (ORR, assessed by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 and Immune Response Evaluation Criteria in Solid Tumors [iRECIST] criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab.

V. To document the adverse event profile of ipilimumab-nivolumab followed by cabozantinib-nivolumab.

BIOMARKER OBJECTIVES:

I. To evaluate biomarkers associated with exceptional responses in both arms (exceptional responses defined as CRs with treatment discontinuation at 12 months or 24 months).

II. To evaluate whether baseline IL-6 is predictive of outcome in patients treated with cabozantinib-containing regimen.

QUALITY OF LIFE (QOL) OBJECTIVES:

I. To compare health-related quality of life at 18 months post-registration as assessed by the Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (FKSI-19) between patients randomized to nivolumab (nivo) versus (vs) cabozantinib (cabo)/nivo.

II. To compare health-related quality of life as assessed by the FKSI-19 between patients randomized to nivo vs cabo/nivo at other time points.

III. To compare patient-reported fatigue using Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue between patients randomized to nivo vs cabo/nivo.

IV. To compare quality-adjusted survival (overall survival x utility score assessed by EuroQol five-dimensional questionnaire [EQ5D-5L]) between patients randomized to nivo vs cabo/nivo.

OUTLINE:

INDUCTION: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

TREATMENT:

Patients with unconfirmed but clinical progression of disease (iuPD) with clinical instability receive cabozantinib orally (PO) daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity.

Patients with unconfirmed CR (iCR) receive nivolumab IV between 30-60 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients with non-CR/non-PD or iuPD with clinical stability are randomized to 1 of 2 arms.

ARM A: Patients receive nivolumab IV between 30-60 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive nivolumab IV between 30-60 minutes on day 1 and cabozantinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) and blood and urine sample collection, and may also undergo a bone scan as clinically indicated throughout the study.

Conditions studied

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
Stage IV Renal Cell Cancer AJCC v8

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In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's planned enrollment of 1,175 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,175 participants (estimated)

Study arms

Active comparator
Arm A (nivolumab)
INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. TREATMENT: Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-CR/non-PD with clinical stability receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood and urine sample collection, and may also undergo a bone scan as clinically indicated throughout the study.
Procedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Biological: Ipilimumab · Procedure: Magnetic Resonance Imaging · Biological: Nivolumab · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Experimental
Arm B (nivolumab, cabozantinib)
INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. TREATMENT: Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity. Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-CR/non-PD rwith clinical stability eceive nivolumab IV over 30 minutes on day 1 and cabozantinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood and urine sample collection, and may also undergo a bone scan as clinically indicated throughout the study.
Procedure: Biospecimen Collection · Drug: Cabozantinib · Procedure: Computed Tomography · Biological: Ipilimumab · Procedure: Magnetic Resonance Imaging · Biological: Nivolumab · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

ProcedureBiospecimen Collection
Undergo blood and urine sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
ProcedureBone Scan
Undergo bone scan
Also known as: Bone Scintigraphy
DrugCabozantinib
Given PO
ProcedureComputed Tomography
Undergo CT scan
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
BiologicalIpilimumab
Given IV
Also known as: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016, Ipilimumab Biosimilar CS1002, MDX 010, MDX-010, MDX-CTLA4, MDX010, Yervoy
ProcedureMagnetic Resonance Imaging
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
BiologicalNivolumab
Given IV
Also known as: ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo
OtherQuality-of-Life Assessment
Ancillary studies
Also known as: Quality of Life Assessment
OtherQuestionnaire Administration
Ancillary studies

What researchers measure

Primary outcomes

Overall survival (OS)
OS of patients who achieve complete response (CR) and progressive disease (PD) from ipilimumab-nivolumab induction phase will be summarized. The stratified log-rank statistic will be the primary analysis to compare the hypothesis on OS with the stratification factors (presence of bone metastases and IMDC risk criteria). The Kaplan-Meier product-limit estimator will be used to estimate the OS. A stratified proportional hazards model will be used to generate estimates for the OS hazard ratio. For the randomized patients, OS will be calculated and compared from the time of randomization until the time of an OS event or time of last-follow-up, whatever occurs first. For the patients who were initially CR or PD, OS will be measured from the time of study registration. A comparison of OS will be made across the patient groups (randomized patients, patients initially CR, and patients initially PD).
Time frame: From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years

Secondary outcomes

Progression-free survival (PFS)
Progression will be defined using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. PFS of patients who achieve CR and PD from ipilimumab-nivolumab induction phase will be summarized (secondary analysis). The Kaplan-Meier product-limit estimator will be used to estimate the PFS distribution. A stratified proportional hazards model will be used to generate estimates for the PFS hazard ratio. For the randomized patients, PFS will be calculated and compared from the time of randomization until the time of a PFS event or time of last-follow-up, whatever occurs first. For the patients who were initially CR or PD, PFS will be measured from the time of study registration. A comparison of PFS will be made across the patient groups (randomized patients, patients initially CR, and patients initially PD). For this comparison, PFS will be measured from time of study registration all the patients, regardless of whether they were randomized or not.
Time frame: From date of registration to date of progression (or disease recurrence) or death due to any cause, whichever occurs first, assessed up to 5 years
Complete response (CR) (randomized patients)
Patients who had a CR prior to 12 months but have experienced a disease recurrence prior to 12 months, will not be considered to be a CR at 12 months. The Cochran-Mantel-Haenszel test will be used to compare the two arms on the proportion of patients who have a 12-month CR adjusting on the stratification factors.
Time frame: At 12 months from date of randomization
Objective response
Defined as the best response observed that has been confirmed by a scan performed 4 or more weeks after the observation of the initial response. The objective response will be confirmed using RECIST 1.1. In addition, objective responses will also be confirmed using Immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Time frame: Up to 5 years
Proportion of patients who discontinue protocol-directed treatment prior to 1 year from date of study registration
Patients who stop their protocol directed treatment for any reason prior to one year from study registration will be considered to have discontinued their treatment. The Cochran-Mantel-Haenszel test will also be used to compare the proportion of patients who discontinue their treatment prior to one-year after study registration.
Time frame: Up to 5 years
Incidence of adverse events
Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. A Fisher's exact test will be used to compare the two treatment arms on the proportion of patient with a grade 3 or higher adverse event.
Time frame: Up to 5 years

Other outcomes

Estimates of OS by sex
Estimates of OS and the corresponding 95% confidence intervals (CIs) by sex will be provided (with an understanding that sometimes the CI or estimate will not be computable because of scant data).
Time frame: From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years
Estimates of OS by race
Estimates of OS and the corresponding 95% CIs by race will be provided (with an understanding that sometimes the CI or estimate will not be computable because of scant data).
Time frame: From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years
Estimates of OS by ethnicity
Estimates of OS and the corresponding 95% CIs by ethnicity will be provided (with an understanding that sometimes the CI or estimate will not be computable because of scant data).
Time frame: From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years

Study locations

859 sites

University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36688, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska 99508, United States
Katmai Oncology Group
Anchorage, Alaska 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska 99508, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701, United States
Kingman Regional Medical Center
Kingman, Arizona 86401, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004, United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas 72703, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas 72758, United States
Highlands Oncology Group
Springdale, Arkansas 72762, United States
Kaiser Permanente-Anaheim
Anaheim, California 92806, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420, United States
PCR Oncology
Arroyo Grande, California 93420, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California 90706, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505, United States
Community Cancer Institute
Clovis, California 93611, United States
University Oncology Associates
Clovis, California 93611, United States
Kaiser Permanente-Fontana
Fontana, California 92335, United States
Kaiser Permanente South Bay
Harbor City, California 90710, United States
Kaiser Permanente-Irvine
Irvine, California 92618, United States
UC San Diego Moores Cancer Center
La Jolla, California 92093, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027, United States
Kaiser Permanente West Los Angeles
Los Angeles, California 90034, United States
Kaiser Permanente-Ontario
Ontario, California 91761, United States
Kaiser Permanente - Panorama City
Panorama City, California 91402, United States
Kaiser Permanente-Riverside
Riverside, California 92505, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817, United States
Kaiser Permanente-Rio San Diego
San Diego, California 92108, United States
Kaiser Permanente-San Diego Zion
San Diego, California 92120, United States
Sharp Memorial Hospital
San Diego, California 92123, United States
Naval Medical Center -San Diego
San Diego, California 92134, United States
UCSF Medical Center-Mission Bay
San Francisco, California 94158, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401, United States
Kaiser Permanente-San Marcos
San Marcos, California 92078, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012, United States
The Medical Center of Aurora
Aurora, Colorado 80012, United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045, United States
Boulder Community Foothills Hospital
Boulder, Colorado 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado 80112, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909, United States
Memorial Hospital North
Colorado Springs, Colorado 80920, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado 80204, United States
Kaiser Permanente-Franklin
Denver, Colorado 80205, United States
National Jewish Health-Main Campus
Denver, Colorado 80206, United States
UCHealth - Cherry Creek
Denver, Colorado 80206, United States
The Women's Imaging Center
Denver, Colorado 80209, United States
AdventHealth Porter
Denver, Colorado 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220, United States
Rose Medical Center
Denver, Colorado 80220, United States
Western Surgical Care
Denver, Colorado 80220, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado 81301, United States
Mercy Medical Center
Durango, Colorado 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado 80113, United States
Swedish Medical Center
Englewood, Colorado 80113, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado 80401, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado 81501, United States
Banner North Colorado Medical Center
Greeley, Colorado 80631, United States
UCHealth Greeley Hospital
Greeley, Colorado 80631, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129, United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado 80026, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado 80026, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado 80228, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120, United States
AdventHealth Littleton
Littleton, Colorado 80122, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado 80124, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado 80124, United States
UCHealth Lone Tree Health Center
Lone Tree, Colorado 80124, United States
Longmont United Hospital
Longmont, Colorado 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501, United States
Medical Center of the Rockies
Loveland, Colorado 80538, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado 80539, United States
AdventHealth Parker
Parker, Colorado 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004, United States
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado 80260, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado 80401, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut 06904, United States

Showing the first 100 of 859 sites across 2 countries.

References and documents

Publications

Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5. No abstract available. PubMed 35383907 ↗
Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18. PubMed 35304832 ↗

Study documents

Informed consent form · Nov 8, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Updates

1 registry update since Sep 25, 2026

Sites

1 site added, 1 site removed

Show site

Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States

Show 1 removed

West Virginia University Charleston Division · Charleston, United States

Oct 1, 2026

Show all 1 update

Oct 1, 2026
1 site added, 1 site removed
Show site
- Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
Show 1 removed
- West Virginia University Charleston Division · Charleston, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03793166
Lead sponsor: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jan 4, 2019
Start date: Jun 7, 2019
Primary completion: Jan 25, 2028 (estimated)
Completion: Jan 25, 2028 (estimated)
Last update: Oct 1, 2026

Study contacts

Tian Zhang

principal investigator · Alliance for Clinical Trials in Oncology

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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