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Renal Cell CarcinomaPhase 1/2NCT03172754

Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

A Phase 1/2 study testing Nivolumab and Axitinib in people with Renal Cell Carcinoma, run by Fox Chase Cancer Center at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Nivolumab and Axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
4 sitesUnited States
Study dates
12 Jun 2017to 6 Apr 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed advanced RCC with predominantly clear cell subtype.
  • Archival tumor biospecimen (when available) must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study.
  • Formalin fixed, paraffin embedded [FFPE] tissue block(s) or at least 12 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.
  • At least one measurable lesion as defined by RECIST version 1.1.
  • Age > 18 years.
  • ECOG performance status 0 or 1
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  • Adequate bone marrow, kidney, and liver function as defined by: WBC ≥ 2000/μL. Neutrophils ≥ 1500/μL. Platelets ≥ 100 x103/μL. Hemoglobin > 9.0 g/dL. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula): Female CrCl = (140 - age in years) x (weight in kg x 0.85)/(72 x serum creatinine in mg/dL). Male CrCl = (140 - age in years) x (weight in kg x 1.00)/(72 x serum creatinine in mg/dL). AST/ALT ≤ 3 x ULN. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
  • No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart. The baseline systolic BP readings must be ≤ 150 mm Hg, and the baseline diastolic BP readings must be ≤ 90 mm Hg
  • Patients enrolled to the prior treatment arm of the expansion cohort must have been exposed to a TKI for metastatic disease OR treated with the combination of ipilimumab and nivolumab in the 1st line setting for metastatic disease. Exposure to TKI as part of (neo)adjuvant treatment that completed within 1 year of study qualifies as prior exposure as well. Prior high dose interleukin-2 is allowed and patients who received this as their only prior line of treatment for metastatic disease may be included in the treatment naïve group.

Who cannot join

  • Prior therapy with axitinib
  • Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to the expansion cohort, treatment naïve arm. If prior (neo)adjuvant treatment given as part of a clinical trial, this would be allowed as long as last dose was > 1 year prior to start of treatment
  • Patients enrolled to the prior treatment arm of the dose escalation cohort must not have received anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
  • Patients are excluded if they have active, symptomatic brain metastases or leptomeningeal metastases. Subjects with known brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for four weeks (after treatment is complete and within 28 days prior to study drug administration.
  • Second malignancy requiring active systemic treatment
  • Diagnosis of immunodeficiency
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  • Active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Patients have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Major surgery <4 weeks or radiation therapy <2 weeks of study entry. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
  • Gastrointestinal abnormalities including: Inability to take oral medication; Requirement for intravenous alimentation; Prior surgical procedures affecting absorption including total gastric resection; Treatment for active peptic ulcer disease in the past 6 months; Active gastrointestinal bleeding as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; Malabsorption syndromes.
  • Evidence of inadequate wound healing.
  • Active bleeding disorder or other history of significant bleeding episodes within 30 days before study entry.
  • Known prior or suspected hypersensitivity to study drugs or any component in their formulations.
  • Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.
  • Current use or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.
  • As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatotoxicity should be used with caution in patients treated with nivolumab-containing regimen.
  • Known hepatitis B virus (HBV) or hepatitis C virus (HBV) infection.
  • Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • History of any of the following cardiovascular conditions within 12 months of screening: Myocardial infarction, Unstable angina pectoris, Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association, Cerebrovascular accident or transient ischemic attack
  • History of deep vein thrombosis or pulmonary embolism within 6 months of screening. Patients who are currently taking anticoagulation therapy for a prior history (> 6 months from screening) of thrombosis may still be eligible.
  • Pregnant or breast feeding.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • US Oncology and Hematology

    Albany, New York, 12206

  • Johns Hopkins

    Baltimore, Maryland, 21231

  • Cornell

    New York, New York, 10021

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Phase I/II Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naïve patients.

Being tested
Nivolumab, Axitinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    PD-1 inhibitor

  • AxitinibDrug

    Tyrosine kinase inhibitor

Study groups in NCT03172754
Study groupRoleWhat they receive
Phase I patientsExperimentalPhase I patients must have received at least 1 prior tyrosine kinase inhibitor for RCC.
Receives: Drug: Nivolumab; Drug: Axitinib
Phase II patients: cohort 1ExperimentalPhase II cohort 1 patients must have received at least 1 prior tyrosine kinase inhibitor for RCC.
Receives: Drug: Nivolumab; Drug: Axitinib
Phase II patients: cohort 2ExperimentalPhase II cohort 2 patients must not have received prior systemic therapy for advanced RCC.
Receives: Drug: Nivolumab; Drug: Axitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-related adverse events

    To be assessed by CTCAE v4.03. Will be used to establish recommended phase II dose (RP2D)

    Measured: Up to 15 months

  2. Overall response rate (ORR)

    To be assessed by RECIST 1.1

    Measured: Up to 12 months

Secondary outcomes (7)

  1. Duration of response (DOR)

    DOR is the time from first partial response or complete response until progressive disease as assessed by RECIST 1.1

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks

  2. Progression free survival (PFS)

    PFS is the time from initiation of treatment to confirmed disease progression per RECIST 1.1

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks

  3. Overall survival (OS)

    OS is the time from initiation of treatment to death or when the patient is lost to follow up

    Measured: From date of initiation of treatment to death or when the patient is lost to follow up, approximately 25 months on average

  4. Safety profile as assessed by CTCAE 4.03

    Summarized by type, frequency, and severity

    Measured: Up to 15 months

  5. PD-L1 expression on tumor biospecimens

    Descriptive statistics from analysis of patient samples

    Measured: Up to 12 months

  6. Tumor infiltrating lymphocyte assessments on tumor biospecimens

    Descriptive statistics from analysis of patient samples

    Measured: Up to 12 months

  7. Pharmacodynamic effect of study treatment including cytokines

    Descriptive statistics from analysis of patient samples

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2017
  2. Study start12 Jun 2017
  3. Primary completion6 Nov 2026 (estimated)
  4. Study completion6 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03172754
Sponsor's protocol ID
GU-102
Other IDs
17-1009
Status last verified
May 2026
First submitted
11 Apr 2017
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab and Axitinib in people with Renal Cell Carcinoma, run by Fox Chase Cancer Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse events (time frame: Up to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03172754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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