A Study of Atezolizumab in Combination With Bevacizumab in Untreated Locally Advanced or Metastatic Clear Cell or Non-Clear Cell Renal Cell Carcinoma

Roche

Status and phase

Withdrawn

Phase 3

Conditions

Renal Cell Carcinoma

Treatments

Drug: Bevacizumab

Drug: Atezolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03693573

MO39939

Details and patient eligibility

About

Study MO39939 is an open-label, single-arm, multicenter trial in patients with unresectable, locally-advanced or metastatic, clear or non-clear cell renal cell carcinoma (RCC) who have not received prior systemic therapy (who are treatment naïve in either the [neo]adjuvant or advanced/metastatic setting for clear and non-clear cell RCC). The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit occurring approximately 30 days after the last dose of study medication, and a Follow-Up Period of 4 years after last patient enrolled.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Unresectable, advanced or metastatic RCC with clear cell or non-clear cell histology
No prior treatment with active or experimental systemic agents for RCC
Measurable and/or non-measurable but evaluable baseline disease per RECIST v1.1
Confirmed diagnosis of RCC
Karnofsky Performance Score (KPS) ≥ 60
Adequate hematologic and end-organ function
Patients with asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
- Evaluable disease outside the CNS
- No history of intracranial or spinal cord hemorrhage
- No evidence of significant vasogenic edema
- No stereotactic radiation within 7 days or whole-brain radiation or neurosurgical resection within 2 weeks before the start of study treatment
- Have had a screening CNS radiography ≥ 2 weeks since completion of radiotherapy or surgical resection
For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm

Exclusion criteria

Prior treatment for RCC with active or experimental systemic agents, including treatment in the neoadjuvant or adjuvant setting - Confirmed prior treatment with placebo in the (neo)adjuvant setting is allowed
Radiotherapy ongoing at the time of study entry
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Patients with indwelling catheters are allowed
Uncontrolled or symptomatic hypercalcemia - Patients who are currently receiving bisphosphonate therapy without current hypercalcemia are eligible
History of malignancy other than RCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Life expectancy of < 12 weeks
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Active tuberculosis
Significant renal disorder requiring dialysis
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
Patients with active hepatitis B or hepatitis C
Current treatment with anti-viral therapy for HBV
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications