IRB #

STUDY00025131

Title

[NCI CIRB] S2200 (PAPMET2): A Phase II Randomized Trial of Cabozantinib (NSC #761968) with or Without Atezolizumab (NSC #783608) in Patients with Advanced Papillary Renal Cell Carcinoma

Principal Investigator

Christopher Ryan

Study Purpose

This study is being conducted to help determine if we can lower the chance of the cancer growing or spreading by adding a drug (atezolizumab) to one of the standard treatments (cabozantinib) for papillary renal cell carcinoma (PRCC)

Medical Condition(s)

Metastatic Papillary Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

- 18 years of age and older
- Participants must have a Zubrod performance status of 0-2
- Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2
- Participants must have measurable disease, per RECIST
- Participants must not have evidence of tumor invading or encasing any major blood vessels
- Participants must not have had prior treatment with cabozantinib for any reason
- Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage
- Participants must not have evidence of tumor invading or encasing any major blood vessels, the GI tract or evidence of endotracheal or endobronchial tumor
- Participants must not have been diagnosed with a clinically significant autoimmune disease, exceptions such as diabetes, eczema, and vitiligo are allowed
- Participants must not be on steroid doses >10 mg prednisone equivalent

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

If you decide to take part in this study, you will either get the study drugs cabozantinib and atezolizumab, or you will get cabozantinib alone, until your disease gets worse, or the side effects become too severe.

After you finish your study treatment, your doctor will continue to follow your condition up to five years from when you begin the study and watch you for side effects. You will be followed for 5 years after registration or until death, whichever occurs first. If you are removed from treatment for reasons other than your cancer continuing to grow, you will continue to be followed at same intervals as if on treatment (every 3 months for the first 2 years, then every 6 months until 5 years from registration).

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503-494-1080

Sponsor

SWOG

Recruitment End

12/31/2024

Compensation Provided

No


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