Trial Outcomes & Findings for Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer (NCT NCT02921269)
NCT ID: NCT02921269
Last Updated: 2023-02-21
Results Overview
Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Complete Response (CR) is the disappearance of all lesions and Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) is CR+PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
Treatment (Atezolizumab, Bevacizumab)
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Atezolizumab, Bevacizumab)
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Did not complete DLT period
|
1
|
Baseline Characteristics
Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=11 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
48 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPer Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Complete Response (CR) is the disappearance of all lesions and Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) is CR+PR.
Outcome measures
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=11 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Participants With Objective Response Rate (ORR, Either Partial or Complete Response) Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to investigator determined date of progression, or death due to any cause, whichever occurs first, assessed up to 2 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm (0.5 cm) or the appearance of one or more new lesions.
Outcome measures
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=11 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Progression Free Survival
|
2.9 months
Interval 1.8 to 6.0
|
SECONDARY outcome
Timeframe: From start of treatment to death, assessed up to 2 yearsThe duration of OS will be estimated.
Outcome measures
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=11 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Survival (OS)
|
8.9 months
Interval 3.4 to 21.9
|
SECONDARY outcome
Timeframe: Up to 30 days after the last dose of study treatment, on average of 4 monthsPopulation: Overall rate of grade 3-4 adverse events attributable to study drug.
The frequency and severity of adverse events will be assessed in those patients who initiate their study treatment.
Outcome measures
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=11 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Percent of Participants With Adverse Events
|
36.4 percent of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The 8 participants with adequate pretreatment core biopsies were included in the analysis.
The efficacy of the combination of atezolizumab and bevacizumab as measured by objective response, will be described in patients according to PD-L1 positive and PD-L1 negative.
Outcome measures
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=8 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
PD-L1 Expression on Tumor and Immune Cells Measured by Semi-quantitative Immunohistochemistry
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The 8 participants with adequate pretreatment core biopsies were included in the analysis. However, there were insufficient samples to run this assay.
Will be used to describe the efficacy of the combination of atezolizumab and bevacizumab.
Outcome measures
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=8 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Intratumoral and Peripheral T-cell Receptor (TCR) Clonality Assessed by TCR Sequencing
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: The 8 participants with adequate pretreatment core biopsies were included in the analysis.
Will be used to describe the efficacy of the combination of atezolizumab and bevacizumab.
Outcome measures
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=8 Participants
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Tumor Infiltrating Lymphocyte Proportion
|
1.17 percent of CD8 in the tumor
Interval 0.06 to 2.77
|
Adverse Events
Treatment (Atezolizumab, Bevacizumab)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Atezolizumab, Bevacizumab)
n=11 participants at risk
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Cardiac disorders
Hypertension
|
18.2%
2/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Cardiac disorders
Stroke
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Cardiac disorders
Thromboembolic event
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Endocrine disorders
Hyperthyroidism
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Anorexia
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
27.3%
3/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
18.2%
2/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Lipase increased
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Alkaline phosphatase increased
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
18.2%
2/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
General disorders
Fatigue
|
54.5%
6/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
General disorders
Fever
|
27.3%
3/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
General disorders
Pain
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Musculoskeletal and connective tissue disorders
Myalagia
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Nervous system disorders
Arachnoiditis
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Nervous system disorders
Sensorineural hearing loss
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Nervous system disorders
Depression
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Nervous system disorders
Encephalopathy
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Nervous system disorders
Meningitis
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
2/11 • Up to 30 days after the last dose of study treatment, on average of 4 months.
|
Additional Information
ETCTN Grants Administrative Manager
Johns Hopkins University
Phone: 443-927-3568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60