Recurrent or Metastatic, Platinum-refractory Cervical Cancer, Squamous Cell Carcinoma (SCC)
Conditions
Brief summary
The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Interventions
DRUGCemiplimab
Intravenous (IV) administration every 3 weeks (Q3W)
IC chemotherapy options include: 1. Antifolate: Pemetrexed 2. Topoisomerase 1 inhibitor: Topotecan or Irinotecan 3. Nucleoside analogue: Gemcitabine 4. Vinca alkaloid: Vinorelbine The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The criteria listed below are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial. Key Inclusion Criteria: 1. Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy). * Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma) as defined in the protocol 2. Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer) 3. Patient must have measurable disease as defined by RECIST 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 5. ≥18 years old 6. Adequate organ or bone marrow function 7. Received prior bevacizumab therapy or had clinically documented reason why not administered 8. Received prior paclitaxel therapy or had clinically documented reason why not administered Key
Exclusion criteria
1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments 2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway 3. Prior treatment with other systemic immune-modulating agents that was 1. within fewer than 4 weeks (28 days) of the enrollment date, or 2. associated with irAEs of any grade within 90 days prior to enrollment, or 3. associated with toxicity that resulted in discontinuation of the immune modulating agent 4. Active or untreated brain metastases 5. Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo) 6. Active infection requiring therapy 7. History of pneumonitis within the last 5 years 8. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments 9. Concurrent malignancy other than cervical cancer and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug cemiplimab or IC chemo), except for tumors with negligible risk of metastasis or death, such as adequately treated cutaneous squamous cell carcinoma or basal cell carcinoma of the skin or ductal carcinoma in situ of the breast. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded. Note: Other protocol defined Inclusion/Exclusion apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From first dose up to 90 following last dose (~42 months) | Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact. |
| Overall Survival (OS) in the SCC Population | From first dose up to 90 following last dose (~42 months) | Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) Assessed Per RECIST 1.1 | Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months) | DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progressed while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate. |
| Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days) | EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 (not at all) to 4 (very much) except for the items contributing to the GHS/QoL, which are scored 1 (very poor) to 7 (excellent). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms. |
| Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months) | PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who did not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment. |
| Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | From first dose up to 90 following last dose (~36 months) | Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | From first dose up to 90 following last dose (~36 months) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A Treatment-emergent adverse event (TEAE) was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported. |
| Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | From date of randomization up to 40 months | ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm) (\<1 centimeter \[cm\]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Countries
Australia, Belgium, Brazil, Canada, Greece, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
752 participants were screened, 144 participants failed screening, 608 participants randomized to receive cemiplimab or investigator choice of chemotherapy. Control treatment determined before randomization by investigator from options per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Cemiplimab Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. | 304 |
| Investigator Choice (IC) Chemotherapy Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m\^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m\^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m\^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m\^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m\^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. | 304 |
| Total | 608 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 17 | 7 |
| Overall Study | Death | 96 | 98 |
| Overall Study | Disease Progression | 109 | 121 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Non-compliance with Study Drug | 0 | 2 |
| Overall Study | Other | 0 | 2 |
| Overall Study | Participant Decision | 35 | 43 |
| Overall Study | Physician Decision | 1 | 3 |
| Overall Study | Sponsor Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 26 |
Baseline characteristics
| Characteristic | Cemiplimab | Investigator Choice (IC) Chemotherapy | Total |
|---|---|---|---|
| Age, Continuous | 51.1 Years STANDARD_DEVIATION 11.59 | 51.2 Years STANDARD_DEVIATION 11.77 | 51.1 Years STANDARD_DEVIATION 11.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 47 Participants | 44 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 251 Participants | 250 Participants | 501 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 10 Participants | 16 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 88 Participants | 88 Participants | 176 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 12 Participants | 21 Participants |
| Race/Ethnicity, Customized Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 193 Participants | 192 Participants | 385 Participants |
| Sex: Female, Male Female | 304 Participants | 304 Participants | 608 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 234 / 300 | 249 / 290 | 2 / 8 |
| other Total, other adverse events | 239 / 300 | 253 / 290 | 4 / 8 |
| serious Total, serious adverse events | 100 / 300 | 84 / 290 | 1 / 8 |
Outcome results
Primary
Overall Survival (OS)
Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
Time frame: From first dose up to 90 following last dose (~42 months)
Population: The full analysis set (FAS) included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cemiplimab | Overall Survival (OS) | 11.7 Months |
| Investigator Choice (IC) Chemotherapy | Overall Survival (OS) | 8.5 Months |
p-value: <0.0000195% CI: [0.555, 0.796]Stratified Log-rank Test
Primary
Overall Survival (OS) in the SCC Population
Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
Time frame: From first dose up to 90 following last dose (~42 months)
Population: All randomized participants who presented SCC (Squamous cell carcinoma) histology. Here 'n' = the number of evaluable participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cemiplimab | Overall Survival (OS) in the SCC Population | 10.9 Months |
| Investigator Choice (IC) Chemotherapy | Overall Survival (OS) in the SCC Population | 8.8 Months |
p-value: 0.0002495% CI: [0.57, 0.855]Stratified Log-rank Test
Secondary
Duration of Response (DOR) Assessed Per RECIST 1.1
DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progressed while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.
Time frame: Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months)
Population: The FAS included all randomized participants with confirmed CR or PR. Here 'n' = number of evaluable participants at a specified timeframe.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cemiplimab | Duration of Response (DOR) Assessed Per RECIST 1.1 | 18.7 Months |
| Investigator Choice (IC) Chemotherapy | Duration of Response (DOR) Assessed Per RECIST 1.1 | 7.2 Months |
Secondary
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.
Time frame: From first dose up to 90 following last dose (~36 months)
Population: The SAF included all randomized participants who received any study drug. Here 'n' = number of evaluable participants at a specified timeframe.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cemiplimab | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Hematology (Grades 3/4) | 84 Participants |
| Cemiplimab | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Electrolytes (Grades 3/4) | 47 Participants |
| Cemiplimab | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Chemistry (Other) (Grades 3/4) | 12 Participants |
| Cemiplimab | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Liver Function (Grades 3/4) | 28 Participants |
| Investigator Choice (IC) Chemotherapy | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Liver Function (Grades 3/4) | 23 Participants |
| Investigator Choice (IC) Chemotherapy | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Hematology (Grades 3/4) | 137 Participants |
| Investigator Choice (IC) Chemotherapy | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Chemistry (Other) (Grades 3/4) | 10 Participants |
| Investigator Choice (IC) Chemotherapy | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Electrolytes (Grades 3/4) | 32 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A Treatment-emergent adverse event (TEAE) was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.
Time frame: From first dose up to 90 following last dose (~36 months)
Population: The safety analysis set (SAF) included all randomized participants who received any study drug. Here 'n' = number of evaluable participants at a specified timeframe.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cemiplimab | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Participants with any TEAE | 269 Participants |
| Cemiplimab | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Participants with any Serious TEAE | 96 Participants |
| Cemiplimab | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Participants with any TEAE leading to Death | 5 Participants |
| Investigator Choice (IC) Chemotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Participants with any TEAE | 266 Participants |
| Investigator Choice (IC) Chemotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Participants with any Serious TEAE | 78 Participants |
| Investigator Choice (IC) Chemotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Participants with any TEAE leading to Death | 2 Participants |
Secondary
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm) (\<1 centimeter \[cm\]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From date of randomization up to 40 months
Population: The FAS included all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cemiplimab | Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | 52 Participants |
| Investigator Choice (IC) Chemotherapy | Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | 19 Participants |
p-value: 0.0000295% CI: [1.798, 5.468]Stratified Cochran-Mantel-Haenszel test
Secondary
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who did not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.
Time frame: Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)
Population: The FAS included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cemiplimab | Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 2.8 Months |
| Investigator Choice (IC) Chemotherapy | Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 2.9 Months |
p-value: 0.0003195% CI: [0.623, 0.882]Stratified Log-rank Test
Secondary
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales
EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 (not at all) to 4 (very much) except for the items contributing to the GHS/QoL, which are scored 1 (very poor) to 7 (excellent). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.
Time frame: From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
Population: The FAS included all randomized participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Cemiplimab | Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL | 0.46 Score on a Scale |
| Cemiplimab | Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning | -0.27 Score on a Scale |
| Investigator Choice (IC) Chemotherapy | Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning | -8.86 Score on a Scale |
| Investigator Choice (IC) Chemotherapy | Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL | -8.54 Score on a Scale |