Phase II Study of Atezolizumab + Bevacizumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Advanced Non-Clear Cell Kidney Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 65
- Locations
- 4
- Primary Endpoint
- Best Overall Response Rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This research study is studying the combination of Atezolizumab and Bevacizumab as a possible treatment for Advanced Non-Clear Cell Kidney Cancer.
Detailed Description
This research study is a Phase II clinical trial. In this research the investigators are studying the combination of Atezolizumab with Bevacizumab. Participants will receive both vascular endothelial targeted therapy and immunotherapy. The FDA (the U.S. Food and Drug Administration) has not approved Atezolizumab for Advanced Non-Clear Cell Kidney Cancer, but it has been approved for other uses. The FDA has approved Bevacizumab with Interferon (IFNα) as a treatment option for Advanced Kidney Cancer.
Investigators
Toni Choueiri, MD
Toni K. Choueiri, MD
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years.
- •Unresectable advanced or metastatic non-clear cell RCC to include but not limited to:
- •Papillary RCC, any type
- •Unclassified RCC
- •Translocation RCC
- •Chromophobe RCC
- •Collecting duct RCC
- •Medulary RCC
- •Clear cell RCC or any histology with \> 20% sarcomatoid features will be eligible.
- •Other non-clear cell histologies that are not included above need to be discussed with the PI.
Exclusion Criteria
- Not provided
Arms & Interventions
Bevacizumab And Atezolizumab Combination
1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Intervention: Bevacizumab
Bevacizumab And Atezolizumab Combination
1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Intervention: Atezolizumab
Outcomes
Primary Outcomes
Best Overall Response Rate
Time Frame: Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. The median (range) of treatment time was 9.5 (1-42) cycles, thus participants were assessed up to ~32 months .
The best overall response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response recorded on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CR and PR must meet the following lesion criteria without having any new lesions as well: Target Lesion: (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Non-Target Lesion: (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Non-CR/Non-Progressive Disease: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion.
Secondary Outcomes
- Median Progression Free Survival(Participants followed for up to 32 months.)
- 1-Year Overall Survival(1 year)
- Best Overall Response Rate by Histological Subtypes(Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. The median (range) of treatment time was 9.5 (1-42) cycles, thus participants were assessed up to ~32 months)
- Percentage of Participants With Treatment-related Adverse Events(Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months).)
- 6-Month Progression-Free Survival by International Metastatic Renal Cell Carcinoma Risk Group(6 months)
- 1-Year Overall Survival by International Metastatic Renal Cell Carcinoma Risk Group(1 year)
- Duration of Response(Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. Off-treatment, patients are followed every 6 months for up to two year. Participants were followed up to 32 months.)
- Immune Related Best Overall Response Rate(Measured every 6 weeks while on treatment. Off-treatment, patients are followed every 6 months for up to two year. Participants were followed up to 32 months.)
- Mean Function Assessment of Cancer Therapy-Kidney Symptom Index-19 Score(Assessed at baseline, week 3, week 5, week 7, week 9, and end of therapy.)
- Brief Fatigue Inventory Score - Items 1-3(Assessed at baseline, week 9, week 15, week 21, week 27, and end of therapy.)
- 6-Month Progression-Free Survival by Histological Subgroups(6 months)
- 1-Year Overall Survival by Sarcomatoid Differentiation(1 year)
- 1-Year Overall Survival by Histological Subgroup(1 year)
- 6-Month Progression-Free Survival by Sarcomatoid Differentiation(6 months)
- Objective Response Rate by Sarcomatoid Differentiation(Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. The median (range) of treatment time was 9.5 (1-42) cycles, thus participants were assessed up to ~32 months .)
- Objective Response Rate by International Metastatic Renal Cell Carcinoma Risk Group(Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. The median (range) of treatment time was 9.5 (1-42) cycles, thus participants were assessed up to ~32 months .)
- 6-Month Progression-Free Survival by Prior Systemic Therapy(6 months)
- 1-Year Overall Survival by Prior Systemic Therapy(1 year)
- Objective Response Rate by Prior Systemic Therapy(Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. The median (range) of treatment time was 9.5 (1-42) cycles, thus participants were assessed up to ~32 months .)