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8110 Gatehouse Road, Falls Church, VA 22042

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk (COSMIC 313


General Information

Age Group




Protocol Number


Background Information

The purpose of this study is to test the safety and effectiveness of cabozantinib (XL184) in combination with nivolumab plus ipilimumab, or placebo in combination with nivolumab plus ipilimumab, in patients with metastatic renal cell cancer.

Cabozantinib is an oral anticancer drug approved in the United States and in other countries. Cabozantinib tablets are approved to treat patients with certain types of advanced kidney cancer (renal cell carcinoma). Cabozantinib is currently being studied - alone or in combination with other drugs - to treat multiple types of cancer.

Nivolumab and ipilimumab are drugs given by intravenous (IV) infusion. This drug combination is approved by the U.S. FDA and other health authorities for the treatment of certain types of kidney cancer that have spread to other areas of the body.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Over the age of 18 years
  • Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component, including subjects who also have a sarcomatoid feature
  • Intermediate- or poor-risk RCC as defined by IMDC criteria (Section 3.4).
  • Measurable disease per RECIST 1.1 as determined by the Investigator. Measurable diseasemust be outside the radiation field if radiation therapy was previously administered
  • Tumor tissue material available for central laboratory PD-L1 testing (most recently obtained archival tumor sample which is less than 2 years prior to the date of informed consent). If archival tissue is not available fresh tumor tissue must be collected and submitted
  • Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. Examples of exceptions are subjects with Grade 2 neuropathy or alopecia who are allowed for trial participation
  • Additional eligibility in protocol

Ineligibility Information

  • Prior systemic therapy for unresectable locally advanced or metastatic RCC including investigational agents

    - Note: One prior adjuvant therapy is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy

    - Note: Adjuvant therapy with a PD-(L)1 inhibitor in combination with a CTLA-4 inhibitor is not permitted
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks prior to randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization. Subjects who are neurologically symptomatic or are receiving systemic corticosteroid treatment at the planned time of randomization are not eligible
  • Additional ineligibility in protocol

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