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Advanced Clear Cell Renal Cell CarcinomaPhase 2NCT05361720

Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study

A Phase 2 study testing Cabozantinib, Ipilimumab and Nivolumab in people with Advanced Clear Cell Renal Cell Carcinoma and Metastatic Clear Cell Renal Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cabozantinib, Ipilimumab and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
6 sitesUnited States
Study dates
6 Dec 2022to 1 Jul 2028
Phase
Phase 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

  • Histological confirmation of RCC with a clear cell component
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer [AJCC] stage IV) RCC
  • Patient can comprehend and sign the study informed consent form
  • Male or female >= 18 years of age at the time of informed consent
  • Karnofsky performance status (KPS) of >= 70%
  • No prior systemic therapy for RCC in the neoadjuvant, adjuvant or metastatic setting
Show all 16Show fewer
  • At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Tumor tissue for ribonucleic acid (RNA)-sequencing (tumor tissue from bony metastasis is not suitable but a soft tissue component around bone is acceptable)
  • Screening tissue consent- Patient must be assigned to either Cluster 1/2 or 4/5. Patients assigned to cluster 3/6/7 will not be eligible for the treatment study
  • Adequate renal function defined as calculated creatinine clearance >= 30 mL/min per the Cockcroft and Gault formula
  • Adequate liver function defined by:
  • Total bilirubin =< 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening and prior to receiving first dose of protocol-indicated treatment
  • Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal
  • Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes

Who cannot join

  • =< 14 days before first dose of protocol-indicated treatment:
  • Major surgery requiring general anesthesia
  • Inadequately controlled hypertension (systolic blood pressure [SBP] > 160/90 mmHg)
  • Anti-hypertensive medications are permitted.
  • Active infection requiring infusional treatment
  • Has preexisting gastrointestinal or non-gastrointestinal fistula
Show all 18Show fewer
  • Proteinuria > 2 g/ 24 hours (hrs)
  • If patient has 1+ protein on urine dipstick then a 24 hr urine collection is required
  • Non-healing wounds on any part of the body (for patients assigned to Cabo/Nivo only)
  • Known clinically significant active bleeding including hemoptysis
  • Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug (for patients assigned to Cabo/Nivo only) - e.g., Crohn's disease, ulcerative colitis, chronic diarrhea (defined as > 4 loose stools per day), malabsorption, or bowel obstruction
  • Significant cardiovascular disease or condition including:
  • Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) functional criteria
  • Unstable angina pectoris (i.e., last episode =< 3 months prior to first dose of protocol-indicated treatment)
  • Myocardial infarction within 3 months prior to starting treatment
  • Subjects with central nervous system (CNS) metastases are eligible after they have completed local therapy (e.g., whole brain radiation therapy [WBRT], surgery or radiosurgery)
  • Any condition requiring systemic treatment with either systemic corticosteroids (> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment
  • In the absence of active autoimmune disease: Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g., topical, ocular, intra-articular, intranasal, and inhalational), =< 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids =< 10 mg/day prednisone or equivalent daily (e.g., hormone replacement therapy needed in patients with hypophysitis)

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vanderbilt-Ingram Service for Timely Access contact

800-811-8480

cip@vumc.org

6 sites in 1 country

United States6 sites, 6 recruiting

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

    Vanderbilt-Ingram Services for Timely Access, cip@vumc.org

    Pedro Barata, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Vanderbilt-Ingram Services for Timely Access, cip@vumc.org

    Moshe Ornstein, MD

    Recruiting

  • University of Texas, Southwestern Medical Center

    Dallas, Texas, 75390

    Vanderbilt-Ingram Services for Timely Access, 800-811-8480, cip@vumc.org

    Tian Zhang, MD

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Vanderbilt-Ingram Services for Timely Access, cip@vumc.org

    Sumantra Pal, MD

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org

    Brian I. Rini, MD

    Recruiting

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Vanderbilt-Ingram Services for Timely Access, cip@vumc.org

    Nataliya Mar, MD

    Recruiting

Other trials in United States

About this study

Official title: Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC RCC)

This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are "immunotherapies" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a "targeted therapy" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To improve objective response rate of front-line therapy in advanced renal cell carcinoma (RCC) by prospectively assigning ipilimumab/nivolumab or nivolumab/cabozantinib according to a patient's ribonucleic acid sequence (RNAseq)-defined biologic cluster.

SECONDARY OBJECTIVE:

  1. To assess clinical outcome of cluster-assigned treatment in front-line metastatic renal cell carcinoma (mRCC).

EXPLORATORY OBJECTIVE:

  1. To assess tissue and peripheral blood for pharmacodynamic correlations with response to treatment.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I:

INDUCTION: Patients receive ipilimumab and nivolumab intravenously (IV) on day 1. Cycles repeat every 21 days for 4 cycles.

MAINTENANCE: Patients receive nivolumab IV on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV on day 1 and cabozantinib orally (PO) once a day (QD). Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 30 days from last dose.

Medical subject headings
Clear-cell metastatic renal cell carcinoma, Carcinoma, Renal Cell

What participants receive

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

  • CabozantinibDrug

    Given PO

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010

    Given IV

  • NivolumabBiological

    Also called BMS-936558, CMAB819, MDX-1106, NIVO

    Given IV

Study groups in NCT05361720
Study groupRoleWhat they receive
Arm I (ipilimumab, nivolumab)ExperimentalINDUCTION: Patients receive ipilimumab and nivolumab IV on day 1. Cycles repeat every 21 days for 4 cycles. MAINTENANCE: Patients receive nivolumab IV on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Ipilimumab; Biological: Nivolumab
Arm II (nivolumab, cabozantinib)ExperimentalPatients receive nivolumab IV on day 1 and cabozantinib PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cabozantinib; Biological: Nivolumab

What is being measured

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

  1. Overall response rate (ORR) (Arm 1)

    Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. ORR = complete response (CR) + partial response (PR). The Agresti-Coull two-sided 95% confidence intervals (CIs) for the success rate will be reported.

    Measured: Up to 4 years

  2. Overall response rate (Arm 2)

    Assessed per RECIST 1.1. ORR = CR + PR. The Agresti-Coull two-sided 95% CIs for the success rate will be reported.

    Measured: Up to 4 years

Secondary outcomes (3)

  1. Progression free survival

    Possible risk factors will be compared for survival with Kaplan-Meier estimates and log-rank tests. The proportional hazards model will be used for adjusting tests of significance and estimating the hazard ratios. Will apply the generalized estimating equation (GEE) statistical procedure for longitudinal binary data analysis with multiple observable vectors for the same subject. For the continuous multiple time points or correlated data, will use the mixed effects model to conduct the profile analysis. The adjusted 95% CIs will be reported.

    Measured: Up to 4 years

  2. Depth of response > 80%

    Will apply the GEE statistical procedure for longitudinal binary data analysis with multiple observable vectors for the same subject. For the continuous multiple time points or correlated data, will use the mixed effects model to conduct the profile analysis. The adjusted 95% CIs will be reported.

    Measured: At 6 months

  3. Incidence of immune-related adverse events

    Adverse medical events will be tabulated. National Cancer Institute toxicity grade 3 and grade 4 laboratory abnormalities will be listed.

    Measured: Up to 4 years

Timeline

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

  1. First posted5 May 2022
  2. Study start6 Dec 2022
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Jul 2028 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05361720
Sponsor's protocol ID
VICCURO21103
Other IDs
NCI-2022-03150, VICCURO21103, P30CA068485, CDMRP-KC210255
Status last verified
Aug 2026
First submitted
25 Apr 2022
Last updated
19 Aug 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 2 study testing Cabozantinib, Ipilimumab and Nivolumab in people with Advanced Clear Cell Renal Cell Carcinoma and Metastatic Clear Cell Renal Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 6 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 16 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 phase mean?

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?

Contact Vanderbilt-Ingram Service for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (Arm 1) (time frame: Up to 4 years). 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 NCT05361720.

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 19 Aug 2026.

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