Extensive-stage Small Cell Lung Cancer
Conditions
Keywords
Extensive stage small cell lung cancer
Brief summary
The purpose of the study is to determine whether adding vorolanib to atezolizumab will improve the length of time that participants are cancer-free after receiving standard chemotherapy.
Interventions
DRUGVorolanib
Vorolanib is administered orally at a dose of 200 mg on Days 1 through 21 of each 21-day cycle.
DRUGAtezolizumab
Atezolizumab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.
Sponsors
Xcovery Holdings, Inc.
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed extensive stage small cell lung cancer without prior specific systemic therapy aside from induction with platinum, etoposide, and atezolizumab. Measurable disease is not required for eligibility. * Receipt of at least 3 cycles (and no more than 4 cycles) of platinum plus etoposide and atezolizumab during the induction phase, without tumor progression as determined by CT scan and brain MRI. Patients should be able to start the study treatment no more than 6 weeks from the last dose of induction chemo/immunotherapy. This period may be extended to 8 weeks in patients requiring brain radiotherapy after completion of induction chemo/immunotherapy for brain metastases. * At least 18 years of age. * ECOG performance status ≤ 1 * Normal bone marrow and organ function as defined below: * Absolute neutrophil count ≥ 1.5 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases) * Creatinine ≤ 1.5 x IULN OR measured or calculated creatinine clearance \> 50 mL/min for patients with creatinine levels \> 1.5 x IULN * Urine protein ≤ 1+ or urine protein to creatinine ratio ≤ 1; if UPC ratio is \> 1 on urinalysis, then 24-hour urine collection for protein must be obtained and level must be \< 1,000 mg for patient enrollment * aPTT and either INR or PT ≤ 1.5 x IULN unless participant is receiving anticoagulant therapy as long as PT or a PTT is within therapeutic range of intended use of anticoagulants. * Patients receiving therapeutic non-Coumadin anticoagulation are eligible, provided they are on a stable dose (per investigator judgment) of anticoagulant. * The effects of atezolizumab and vorolanib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 31 weeks after last dose of study treatment. Women must use birth control for at least 31 weeks after last dose of study treatment. Women must not be breastfeeding. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion criteria
* A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease. * Currently receiving any other investigational agents. * Patients with untreated brain metastases are excluded. Patients with clinically evident CNS hemorrhage are excluded. Prophylactic cranial irradiation is not allowed. Patients with brain metastases treated with whole brain radiation therapy, radiosurgery, or surgery are eligible. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorolanib, atezolizumab, or other agents used in the study. * Use of chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted. * Systemic glucocorticoids with prednisone dose higher than 10 mg/day or equivalent. * Arterial or venous thromboembolic event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment. * Uncontrolled or poorly controlled hypertension with systolic blood pressure (BP)\> 160 mmHg systolic or diastolic \> 100 mmHg for \> 3 weeks prior to C1D1), despite standard medical management. * Gastrointestinal perforation, and/or fistula, or risk factors for perforation within 6 months prior to enrollment. * Grade 3 or 4 gastrointestinal bleeding within 3 months prior to enrollment. * History of active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. * History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. * Hemoptysis (defined as bright red blood or ≥ ½ teaspoon) within 28 days prior to Cycle 1 Day 1 or with radiographic evidence of intratumor cavitation or radiologically documented evidence of major blood vessel invasion or encasement by cancer. * Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to Cycle 1 Day 1. * Undergone major surgery within 28 days prior to Cycle 1 Day 1, or minor surgery/subcutaneous venous access device placement within 7 days prior to Cycle 1 Day 1, or has elective or planned major surgery to be performed during the course of the clinical trial. * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis at a level of Child-Pugh B or worse, cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (defined as ascites from cirrhosis requiring diuretics or paracentesis), fatty liver, and inherited liver disease. * Active tuberculosis. * Administration of a live, attenuated influenza vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study. * Severe infections within 2 weeks prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. * Received oral or intravenous (IV) antibiotics within 2 weeks prior to Cycle 1 Day 1. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible. * History of deep venous thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant) during the 3 months prior to Cycle 1 Day 1. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to C1D1. * Active hepatitis B (chronic or acute) defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Note: Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test are eligible. * Patients known to be HIV positive are ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months | 6 months | * Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) * Kaplan-Meier product limit estimator will be used to estimate progression-free survival (PFS) at 6 months, with the inclusion of 90% confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression-free Survival (PFS) | Through completion of follow-up for progression-free survival (median length of follow-up 81 days, full range 25-1526 days) | * Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) |
| Median Overall Survival | Through completion of follow-up (median length of follow-up 446 days, full range 93-1526 days) | Overall survival is defined as the length of time from the start of study treatment that patients diagnosed with the disease are still alive. |
| Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | From the start of treatment until 90 days after completion of treatment (median length of follow-up 165 days, full range 93-527 days). | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vorolanib + Atezolizumab Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Vorolanib + Atezolizumab |
|---|---|
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 11 |
| other Total, other adverse events | 11 / 11 |
| serious Total, serious adverse events | 3 / 11 |
Outcome results
Primary
Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months
* Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) * Kaplan-Meier product limit estimator will be used to estimate progression-free survival (PFS) at 6 months, with the inclusion of 90% confidence interval.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vorolanib + Atezolizumab | Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months | 27.3 percentage of participants-Kaplan Meier |
Secondary
Median Overall Survival
Overall survival is defined as the length of time from the start of study treatment that patients diagnosed with the disease are still alive.
Time frame: Through completion of follow-up (median length of follow-up 446 days, full range 93-1526 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vorolanib + Atezolizumab | Median Overall Survival | 14.6 months |
Secondary
Median Progression-free Survival (PFS)
* Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Time frame: Through completion of follow-up for progression-free survival (median length of follow-up 81 days, full range 25-1526 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vorolanib + Atezolizumab | Median Progression-free Survival (PFS) | 2.7 months |
Secondary
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Time frame: From the start of treatment until 90 days after completion of treatment (median length of follow-up 165 days, full range 93-527 days).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 periorbital edema | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 teeth sensitivity | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hypotension | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 hypotension | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 anemia | 9 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 anemia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 eosinophilia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 leukocytosis | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 sinus tachycardia | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 vertigo | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 adrenal insufficiency | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 allergic conjunctivitis (discharge from eyes due to allergies) | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 bilateral eye drainage - intermittent | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 abdominal pain | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 bloating | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 constipation | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 diarrhea | 5 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 diarrhea | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 dry mouth | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 nausea | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 nausea | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 typhitis | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 vomiting | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 vomiting | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 toothache | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 edema limbs | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 non cardiac chest pain | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 generalized weakness | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 chills | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 fatigue | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 fatigue | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 fever | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 gait disturbance | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 malaise | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 malaise | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 allergic reaction (poison sumac) | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 COVID-19 infection | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 urinary tract infection | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 lung infection | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 sepsis | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 thrush | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 sunburn | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 bruising | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 neutrophil count decreased | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 neutrophil count decreased | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 transaminitis | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 activated partial thromboplastin time prolonged | 4 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 alanine aminotransferase increased | 5 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 alanine aminotransferase increased | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 alkaline phosphatase | 4 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 aspartate aminotransferase increased | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 aspartate aminotransferase increased | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 blood bilirubin increased | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 blood lactate dehydrogenase increased | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 creatinine increased | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 INR increased | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 lipase increased | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 lymphocyte count decreased | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 platelet count decreased | 5 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-4 platelet count decreased | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 white blood cell decreased | 4 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 malnutrition | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 anorexia | 4 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hyperglycemia | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hypertriglyceridemia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hypoalbuminemia | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hypocalcemia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 hypocalcemia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hypoglycemia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hypokalemia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 hypokalemia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hyponatremia | 4 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 hyponatremia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 groin pain | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 groin pain | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 muscle aches | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 arthralgia | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 back pain | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 flank pain | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 generalized muscle weakness | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 generalized muscle weakness | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 dizziness | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 headache | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 paresthesia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 seizure | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 insomnia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 chronic kidney disease (decreased eGFR) | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 glucosuria | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hematuria | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 proteinuria | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 orthopnea | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 acute hypoxemic respiratory failure | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 allergic rhinitis | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 cough | 3 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 dyspnea | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 dyspnea | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 epistaxis | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 hypoxia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 pleural effusion | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 rhinorrhea | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 sore throat | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 rash maculo-papular | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 alopecia | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 dry skin | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hair color changes | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 pruritus | 1 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 1-2 hypertension | 2 Participants |
| Vorolanib + Atezolizumab | Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events | Grade 3-5 hypertension | 2 Participants |