Introduction

This clinical trial summary provides a general overview of the Children’s Oncology Group (COG) study AREN1721. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form. You can get this from your oncologist.

This study will be combining the resources of the Children’s Oncology Group (COG) and other adult cooperative groups through the National Clinical Trials Network (NCTN) and will be open to pediatric and adult patients.

AREN1721 is a Phase 2 clinical trial. A trial is another word for a study. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about treatment – its safety and how well it works. The purpose of a Phase 2 trial is to learn if a new treatment works in treating a specific type of cancer and how it affects the body.

In a Phase 2 trial, patients with a specific type of cancer receive a new treatment using a dose that was found to be safe in a Phase I trial. Patients are checked for side effects of the treatment and to see whether the cancer shrinks or goes away.

Phase 2 trials are offered to patients whose disease has not responded to standard types of treatments or to patients whose disease doesn’t have a standard treatment.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at www.childrensoncologygroup.org. Always discuss any questions that you may have with your health care team.

Study Number

AREN1721

Study Title

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups.

Study Opening Date

AREN1721 opened on 10/9/2018. This study will enroll approximately 87 patients and will remain open until all patients are enrolled.

General Patient Eligibility

  • Age: 12 months and older
  • Diagnosis: TFE/Translocation Renal Cell Carcinoma (tRCC)
  • Tumor cannot be surgically removed (unresectable) or has spread to other parts of the body (metastatic)
  • Patients may be newly diagnosed or have received cancer therapy before
  • As of amendment 2A, prior therapy with one line of non-axitinib anti-VEGF based therapy is acceptable
  • Patients with the following are not eligible:
    • Patients who are not able to swallow whole tablets
    • Patients with certain pre-existing conditions or who have received certain therapies

Please consult your doctor to determine whether you or your child may participate in this study.

General Background and Study Goal

There are no formal treatment recommendations for a diagnosis of tRCC. New ways, other than traditional chemotherapy, are needed to treat tRCC. This study will see how well the medications Axitinib and Nivolumab work in the treatment of tRCC. These medications are not chemotherapy, but targeted cancer therapies. Targeted cancer therapies block the growth and spread of cancer by focusing on specific processes that play an important role in cancer cell growth. They target these processes so that cancer cells lose the ability to grow.

The goal of this randomized three-arm study is to see how well axitinib and nivolumab given on their own, or given together, work for the treatment of tRCC.

Summary of the Treatment

  • All patients will now be randomly assigned to either arm A or arm C per below:
    • Arm A: Axitinib + Nivolumab
    • Arm B: Axitinib alone (Closed as of Amendment 2A)
    • Arm C: Nivolumab alone
  • Axitinib is given by mouth twice a day for 28 days
  • Nivolumab is given intravenously (by IV) every two weeks
  • Each cycle consists of 28 days for all arms
  • Patients may remain on study up to 2 years or after completing 26 cycles, whichever comes first.

 

Special Considerations

  • If randomly assigned to the Axitinib-containing arm (Arm A), patients will be monitored weekly during cycle 1 for hypertension (high blood pressure).
  • Participating patients receiving Axitinib must be able to swallow whole tablets.
  • Participating patients of reproductive age who are sexually active must agree to use an effective method of contraception throughout the study and continue this until 5 months (females) and 7 months (males) after the last dose of axitinib or nivolumab.

 

Risks and Side Effects

Cancer therapy can cause side effects during and after treatment. All patients will be closely monitored for possible side effects of the medicines. All risks and side effects will be explained by your treatment team during the consent process. They can answer any questions that you may have about giving permission for you or your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your or your child's oncologist and nurses are the best sources for further information.

Study Chair

James Geller, MD
Cincinnati Children’s Hospital Medical Center

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS

Initial development Name Date
Written by (protocol nurse) Denise Mills RN, MN NP, CPHON August 14, 2019
Reviewed/approved by (PI) James Geller, MD April 14, 2020
Ongoing review
Reviewed and updated by