Bevacizumab
DrugOther names: Avastin
NCT Number: NCT02724878
This research study is studying the combination of Atezolizumab and Bevacizumab as a possible treatment for Advanced Non-Clear Cell Kidney Cancer.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
University of California, San Diego Moores Cancer Center, La Jolla, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
•Prior treatment with CD137 agonists, anti- cytotoxic T-lymphocyte-associated protein 4, anti-PD-1, or anti-PDL1 therapeutic antibody or pathway targeting agents.
Prior IFNα or IL-2 is allowed following 4 week washout from treatment end date.
Other names: Avastin
Other names: RG-7446
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.
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. Please see the primary endpoint "Best Overall Response Rate" description for the definition of CR and PR.
Non-clear cell renal cell carcinoma includes different histologic and genetic subtypes to include: papillary, chromophobe, collecting duct, unclassified, translocation, and medullary carcinoma. These subtypes are measured using established methods.
Time frame: Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months).
Assessed by -Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All treatment-related all-grade adverse events occurring in >10% of participants.
Treatment Related is discerned as follows:
Time frame: 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.
The duration of overall response (based on RECIST 1.1) is measured from the time measurement criteria are met for CR and PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented taking as reference for progressive disease the smallest measurements recorded since the treatment started or death due to any cause. Participants without events reported are censored at the last disease evaluation.
Time frame: 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.
The best overall Immune-Related Complete Response (irCR) or Immune-Related Partial Response (irPR) is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
irCR: Complete disappearance of all target lesions in two consecutive observations not less than 4 weeks apart. This category encompasses exactly the same subjects as complete response (CR).
irPR: Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters (SPD) of all target and all new measurable lesions in two consecutive observations not less than 4 weeks apart. Note: the appearance of new measurable lesions is factored into the overall tumor burden, but does not automatically qualify as progressive disease until the SPD increases by > 25% when compared to SPD at nadir.
Time frame: Participants followed for up to 32 months.
Progression free survival (PFS) is defined as the time from start of treatment to disease progression (PD) or death from any cause as estimated by Kaplan Meier methods. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST) as follows:
OR
-Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment.
Time frame: 1 year
1-Year Overall Survival (OS) is defined as the probability of survival at 1 year from treatment start date. Survival probability is estimated using Kaplan Meier methods. An event is considered to be death due to any cause. Participants who are lost to follow-up before the 1 year mark are censored at date last known alive.
Time frame: Assessed at baseline, week 3, week 5, week 7, week 9, and end of therapy.
The Function Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) is a 19 item questionnaire with each item scored on a scale of 0-4 for a total score of 0-76 with higher scores indicating fewer symptom.
Time frame: Assessed at baseline, week 9, week 15, week 21, week 27, and end of therapy.
The Brief Fatigue Inventory Score (BFI) is a 9 item questionnaire with each items 1-3 scored on a scale of 0-10 Scores are categorized is mild (1-3), moderate (4-6), or severe (7-10). A global fatigue score can be found by averaging the score obtained on each test item completed. Items 1-3 of the 9 are reported here.
Time frame: 6 months
6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows:
OR
-Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment.
Histological subgroups are categorized using established methods.
Time frame: 1 year
1-Year Overall Survival (OS) is defined as the probability of survival at 1 year from treatment start date. Survival probability is estimated using Kaplan Meier methods. An event is considered to be death due to any cause. Participants who are lost to follow-up before the 1 year mark are censored at date last known alive.
Time frame: 6 months
6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows:
OR
-Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment.
Sarcomatoid Differentiation are categorized using established methods
Time frame: 1 year
1-Year Overall Survival (OS) is defined as the probability of survival at 1 year from treatment start date. Survival probability is estimated using Kaplan Meier methods. An event is considered to be death due to any cause. Participants who are lost to follow-up before the 1 year mark are censored at date last known alive.
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 objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response on treatment using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1).
CR and PR must meet the following 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): >=30% decrease in the sum of the diameters of target lesion, taking as reference the baseline sum diameter.
Non-Target Lesion:
(CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological (<10 mm short axis) Non-CR/Non-Progressive Disease: Persistence of 1+ non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion Sarcomatoid Differentiation are categorized using established methods
Time frame: 6 months
6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows:
OR
-Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at next assessment at investigator discretion if patient is benefiting from treatment.
International Metastatic Renal Cell Carcinoma Risk Group determined by established methods
Time frame: 1 year
1-Year Overall Survival (OS) is defined as the probability of survival at 1 year from treatment start date. Survival probability is estimated using Kaplan Meier methods. An event is considered to be death due to any cause. Participants who are lost to follow-up before the 1 year mark are censored at date last known alive.
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 objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response on treatment using RECIST 1.1.
CR and PR must meet the following 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): >=30% decrease in the sum of the diameters of target lesion, taking as reference the baseline sum diameter.
Non-Target Lesion:
(CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological (<10 mm short axis).
Non-CR/Non-Progressive Disease: Persistence of 1+ non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion.
International Metastatic Renal Cell Carcinoma Risk Group are categorized using established methods
Time frame: 6 months
6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows:
OR
-Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment.
Prior systemic therapy group determined by established methods,
Time frame: 1 year
1-Year Overall Survival (OS) is defined as the probability of survival at 1 year from treatment start date. Survival probability is estimated using Kaplan Meier methods. An event is considered to be death due to any cause. Participants who are lost to follow-up before the 1 year mark are censored at date last known alive.
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 objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response on treatment using RECIST 1.1.
CR and PR must meet the following 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): >=30% decrease in the sum of the diameters of target lesion, taking as reference the baseline sum diameter.
Non-Target Lesion:
(CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological (<10 mm short axis).
Non-CR/Non-Progressive Disease: Persistence of 1+ non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion.
Dana-Farber Cancer Institute
Other
Phase II Study of Atezolizumab + Bevacizumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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