S2200: A Phase II Randomized Trial of Cabozantinib (NSC #761968) with or without Atezolizumab (NSC #783608) in Patients with Advanced Papillary Renal Cell Carcinoma (PAPMET2)
Lay Description
To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib with atezolizumab versus cabozantinib alone
Category
- Urinary Tract and Kidney
- IRB Number
- STUDY00000340
- NCT Number
- NCT # not yet entered
Eligibility
- Eligible Ages
- 18
- Eligible Genders
- All
- Accepts Healthy Volunteers
Inclusion Criteria
Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2. (NOTE: A designation of type 1 or type 2 should be made by the local pathologist if possible but is not required). Mixed histologies which contain type 1 or type 2 along with any other RCC histology/histologies will be allowed provided that they contain a papillary component. b. Participants must have measurable disease per RECIST 1.1 criteria (see Section 10.1). All measurable lesions must be assessed by CT or MRI within 28 days prior to registration. All non-measurable lesions must be assessed by CT or MRI, or nuclear medicine bone scan within 42 days prior to registration. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality as defined in S2200 Section 10.1.c. If there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan must be performed at baseline (within 42 days prior to registration). c. Participants with new or progressive brain metastases (active brain metastases) must not require immediate CNS specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling. d. Participants with measurable disease, per RECIST v1.1, must be present outside the CNS. e. Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage. f. Participants must not have undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment. g. Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease. h. Participants, if needed, must receive a stable dose of anti-convulsant therapy. i. Participants must not have cavitating pulmonary lesions. j. Participants must not have uncontrolled pleural effusions, pericardial effusions, or ascites requiring recurrent drainage procedures (once monthly or more frequently. Participants with indwelling catheters (e.g., PleurX) are allowed k. Participants must not have tumor invading the GI tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration. l. Participants must not have evidence of tumor invading or encasing any major blood vessels.
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Jessica Villarreal
villarreal24@uthscsa.edu
Principal Investigator
Montaser Shaheen