Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
Conditions
Keywords
Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV, CS-1008, Paclitaxel, Carboplatin
Brief summary
This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer.
Detailed description
This trial assessed CS-1008 administered in combination with paclitaxel/carboplatin to patients with Stage IIIC or IV ovarian cancer who had suboptimal debulking surgery with residual measurable/evaluable disease and who had not received prior therapy for their disease. The effect of this first-line treatment in patients was assessed by complete response rate.
Interventions
DRUGCS-1008
CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6
DRUGPaclitaxel
Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles
DRUGCarboplatin
Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles
Sponsors
Daiichi Sankyo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed, epithelial carcinoma of the ovary or primary peritoneal carcinoma (International Federation of Gynecology and Obstetrics \[FIGO\] Stage IIIC or IV). (Participants with the following histologic epithelial cell types are eligible for the study: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified.) * Enrollment within 6 weeks after surgical resection (debulking). * Residual tumor masses \> 1 cm and objectively measurable/evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * No prior therapy for ovarian cancer (ie, chemotherapy or radiotherapy \[RT\] to the abdomen or pelvis) other than surgical debulking of disease. * At least 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Adequate organ and bone marrow function as evidenced by: * Absolute neutrophil count ≥ 1,500/µL (equivalent to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 grade 1) * Platelet count ≥ 100,000/µL (CTCAE grade 0 to 1) * Hemoglobin ≥ 9 g/dL * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) (CTCAE grade 1) * Bilirubin ≤ 1.5 x ULN (CTCAE grade 1) * Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN (CTCAE grade 1) * Adequate neurologic function (ie, sensory and motor neuropathy ≤ CTCAE grade 1). * Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months thereafter. * All subjects of childbearing potential must have a negative pregnancy test (serum or urine) result ≤ 72 hours before initiating study treatment. * Participants must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an institutional review board-approved informed consent form (ICF) before performance of any study-specific procedures or tests.
Exclusion criteria
* Prior invasive malignant disease within 5 years except for squamous cell or basal cell carcinoma. * Current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential) or recurrent ovarian epithelial cancer. * Positive human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) because of the potential for additional toxicity from the treatment regimen. * Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study. * History of any of the following conditions within 6 months before study enrollment: myocardial infarction; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic obstructive pulmonary disease or asthma). * Clinically active brain metastasis (ie, untreated, still requiring therapy with steroids or RT, or with progression within 4 weeks after completion of RT); an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. * Pregnant or lactating. * Prior treatment with CS-1008, other agonistic DR5 antibodies, or tumor necrosis factor-related apoptosis inducing ligand (TRAIL). * Known history of hypersensitivity reactions to any of the components of CS-1008, paclitaxel (or docetaxel), or carboplatin formulations. * Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Baseline up to first documented objective response, disease progression, or study withdrawal, up to 1 year 10 months | The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdraws from the study. If there is no tumor assessment after the first dose of study drug, the best overall response is classified as Inevaluable. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. Objective response rate was defined as confirmed CR and confirmed PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Sum of Longest Diameters of Target Lesions Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Baseline to Cycle 3, Week 3 Day 1; Cycle 6, Week 3 Day 1 (each cycle 21 days) up to end of study, approximately 1 year 10 months postdose | A sum of the diameters for all target lesions will be calculated and reported as the baseline sum of diameters, defined as the last non-missing value before initial administration of study treatment. The baseline sum of diameters will be used as reference for characterization of the objective tumor response. The change from baseline in the sum of longest diameters of target lesions is being reported. Negative values indicate an improvement in tumor reduction. |
| Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Baseline up to 30 days after last dose, up to 1 year 10 months postdose | Treatment-emergent adverse events (TEAEs) were defined as those events that occur, having been absent before the study, or worsen in severity after the initiation of CS-1008 and/or paclitaxel/docetaxel/carboplatin administration. All adverse events (AEs) were graded (1 to 5) according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0, where Grade 1 was mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening or disabling, and Grade 5 death related to AE. |
Countries
United States
Participant flow
Recruitment details
A total of 24 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment at 3 clinic sites in the United States.
Pre-assignment details
Following debulking surgery, participants with suboptimal resection (ie, residual tumor \> 1 cm) and measurable/evaluable tumor by imaging techniques were eligible for participation in this study. Debulking surgery occurred within 6 weeks before enrollment in the study.
Participants by arm
| Arm | Count |
|---|---|
| CS-1008 in Combination With Paclitaxel/Carboplatin Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not achieve a complete response | 18 |
| Overall Study | Disease progression | 3 |
| Overall Study | Investigator's discretion | 1 |
| Overall Study | Participant relocated to another state | 1 |
| Overall Study | Serious adverse event or adverse event | 1 |
Baseline characteristics
| Characteristic | CS-1008 in Combination With Paclitaxel/Carboplatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 59.3 years STANDARD_DEVIATION 9.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 22 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 11 / 24 |
| serious Total, serious adverse events | 9 / 24 |
Outcome results
Primary
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdraws from the study. If there is no tumor assessment after the first dose of study drug, the best overall response is classified as Inevaluable. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. Objective response rate was defined as confirmed CR and confirmed PR.
Time frame: Baseline up to first documented objective response, disease progression, or study withdrawal, up to 1 year 10 months
Population: Best overall tumor response and objective response rate were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Confirmed CR after 6 cycles (18 weeks) of treatment | 0 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Confirmed CR | 0 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Confirmed PR | 12 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Objective Response (Confirmed CR + Confirmed PR) | 12 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Unconfirmed CR | 0 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Unconfirmed PR | 4 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Stable disease (SD) | 5 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Progressive disease (PD) | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Inevaluable | 2 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Best overall response of SD or better | 21 Participants |
Secondary
Change From Baseline in the Sum of Longest Diameters of Target Lesions Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
A sum of the diameters for all target lesions will be calculated and reported as the baseline sum of diameters, defined as the last non-missing value before initial administration of study treatment. The baseline sum of diameters will be used as reference for characterization of the objective tumor response. The change from baseline in the sum of longest diameters of target lesions is being reported. Negative values indicate an improvement in tumor reduction.
Time frame: Baseline to Cycle 3, Week 3 Day 1; Cycle 6, Week 3 Day 1 (each cycle 21 days) up to end of study, approximately 1 year 10 months postdose
Population: The sum of longest diameters of target lesions was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CS-1008 in Combination With Paclitaxel/Carboplatin | Change From Baseline in the Sum of Longest Diameters of Target Lesions Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Cycle 3, Week 3 Day 1 | -39.0 mm | Standard Deviation 41.73 |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Change From Baseline in the Sum of Longest Diameters of Target Lesions Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Cycle 6, Week 3 Day 1 | -52.4 mm | Standard Deviation 41.56 |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Change From Baseline in the Sum of Longest Diameters of Target Lesions Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Minimum post-treatment value | -48.3 mm | Standard Deviation 41.65 |
Secondary
Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Treatment-emergent adverse events (TEAEs) were defined as those events that occur, having been absent before the study, or worsen in severity after the initiation of CS-1008 and/or paclitaxel/docetaxel/carboplatin administration. All adverse events (AEs) were graded (1 to 5) according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0, where Grade 1 was mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening or disabling, and Grade 5 death related to AE.
Time frame: Baseline up to 30 days after last dose, up to 1 year 10 months postdose
Population: Treatment-emergent adverse events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any TEAE ≥Grade 3 | 22 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Blood and Lymphatic System Disorders | 20 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Anaemia | 6 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Febrile neutropenia | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Leukopenia | 2 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Neutropenia | 18 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Pancytopenia | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Thrombocytopenia | 7 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Gastrointestinal Disorders | 6 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Abdominal pain | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Ascites | 2 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Constipation | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Enterocolitis | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Gastrooesophageal reflux disease | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Small intestinal obstruction | 3 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within General Disorders and Administration Site Conditions | 2 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Chills | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Fatigue | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Infections and Infestations | 3 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Abdominal abscess | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Urinary tract infection | 3 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Wound infection staphylococcal | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Investigations | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Prothrombin time prolonged | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Metabolism and Nutrition Disorders | 5 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Dehydration | 2 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Electrolyte imbalance | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Hyperglycaemia | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Hypokalaemia | 2 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Hyponatraemia | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Hypophosphataemia | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Musculoskeletal and Connective Tissue Disorders | 2 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Arthralgia | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Back pain | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Musculoskeletal pain | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Renal and Urinary Disorders | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Renal vein thrombosis | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Any Preferred Term Within Vascular Disorders | 1 Participants |
| CS-1008 in Combination With Paclitaxel/Carboplatin | Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer | Venous thrombosis | 1 Participants |