Trial Outcomes & Findings for Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC (NCT NCT04448886)

Last Updated: 2026-01-15

Results Overview

Compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone. PFS is defined as the time from study randomization to disease progression, according to RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first. Patients alive without disease progression are censored at the date of last disease evaluation.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

110 participants

Primary outcome timeframe

Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024.

Results posted on

2026-01-15

Participant Flow

The study was activated in September 2020 and closed accrual in January 2024. Patients were enrolled from the following sites: University of Chicago, DFCI (Boston, Milford, South Shore, Foxborough), Emory University, University of Pennsylvania, and University of North Carolina (Chapel Hill).

Prior to amendment 3 of the study protocol, the enrolled patient were initially entered into prescreen phase, to verify that their PD-L1+ was greater or equal to 10 by centrally tested 22C3 combined positive score prior to proceeding for the study. This restriction was lifted starting from amendment 3.

Participant milestones

Participant milestones
Measure	Sacituzumab Govitecan + Pembrolizumab The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Overall Study STARTED	52	52
Overall Study COMPLETED	48	51
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle	Total n=104 Participants Total of all reporting groups
Age, Continuous	56.5 Year n=14 Participants	57 Year n=10 Participants	57 Year n=24 Participants
Sex: Female, Male Female	50 Participants n=14 Participants	52 Participants n=10 Participants	102 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=14 Participants	0 Participants n=10 Participants	2 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Asian	4 Participants n=14 Participants	1 Participants n=10 Participants	5 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	4 Participants n=14 Participants	3 Participants n=10 Participants	7 Participants n=24 Participants
Race (NIH/OMB) White	40 Participants n=14 Participants	44 Participants n=10 Participants	84 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=14 Participants	4 Participants n=10 Participants	7 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=14 Participants	2 Participants n=10 Participants	4 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=14 Participants	49 Participants n=10 Participants	95 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=14 Participants	1 Participants n=10 Participants	5 Participants n=24 Participants
ER status at closest date prior to enrollment Positive (>=1% cell staining)	52 Participants n=14 Participants	52 Participants n=10 Participants	104 Participants n=24 Participants
ER status at closest date prior to enrollment Negative (<1% cell staining)	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
PR status at closest date prior to enrollment Positive (>=1% cell staining)	25 Participants n=14 Participants	27 Participants n=10 Participants	52 Participants n=24 Participants
PR status at closest date prior to enrollment Negative (<1% cell staining)	27 Participants n=14 Participants	25 Participants n=10 Participants	52 Participants n=24 Participants
Prior lines of chemotherapy for primary tumor Yes	28 Participants n=14 Participants	28 Participants n=10 Participants	56 Participants n=24 Participants
Prior lines of chemotherapy for primary tumor No	13 Participants n=14 Participants	11 Participants n=10 Participants	24 Participants n=24 Participants
Prior lines of chemotherapy for primary tumor N/A	11 Participants n=14 Participants	13 Participants n=10 Participants	24 Participants n=24 Participants
Prior lines of chemotherapy for metastatic tumor 0 line	26 Participants n=14 Participants	25 Participants n=10 Participants	51 Participants n=24 Participants
Prior lines of chemotherapy for metastatic tumor 1 line	26 Participants n=14 Participants	27 Participants n=10 Participants	53 Participants n=24 Participants
Prior CDK 4/6 inhibitor for primary tumor Yes	7 Participants n=14 Participants	11 Participants n=10 Participants	18 Participants n=24 Participants
Prior CDK 4/6 inhibitor for primary tumor No	34 Participants n=14 Participants	28 Participants n=10 Participants	62 Participants n=24 Participants
Prior CDK 4/6 inhibitor for primary tumor N/A	11 Participants n=14 Participants	13 Participants n=10 Participants	24 Participants n=24 Participants
Prior CDK 4/6 inhibitor for metastatic tumor Yes	46 Participants n=14 Participants	44 Participants n=10 Participants	90 Participants n=24 Participants
Prior CDK 4/6 inhibitor for metastatic tumor No	6 Participants n=14 Participants	8 Participants n=10 Participants	14 Participants n=24 Participants
Prior CDK 4/6 inhibitor ever (for primary or metastatic) Yes	49 Participants n=14 Participants	48 Participants n=10 Participants	97 Participants n=24 Participants
Prior CDK 4/6 inhibitor ever (for primary or metastatic) No	3 Participants n=14 Participants	4 Participants n=10 Participants	7 Participants n=24 Participants
Endocrine therapy for primary tumor Yes	37 Participants n=14 Participants	39 Participants n=10 Participants	76 Participants n=24 Participants
Endocrine therapy for primary tumor No	4 Participants n=14 Participants	0 Participants n=10 Participants	4 Participants n=24 Participants
Endocrine therapy for primary tumor N/A	11 Participants n=14 Participants	13 Participants n=10 Participants	24 Participants n=24 Participants
Brain metastasis present at enrollment/diagnosis Yes	4 Participants n=14 Participants	5 Participants n=10 Participants	9 Participants n=24 Participants
Brain metastasis present at enrollment/diagnosis No	48 Participants n=14 Participants	47 Participants n=10 Participants	95 Participants n=24 Participants
Liver metastasis present at enrollment/diagnosis Yes	40 Participants n=14 Participants	41 Participants n=10 Participants	81 Participants n=24 Participants
Liver metastasis present at enrollment/diagnosis No	12 Participants n=14 Participants	11 Participants n=10 Participants	23 Participants n=24 Participants
Presentation at metastatic diagnosis De novo MBC	11 Participants n=14 Participants	13 Participants n=10 Participants	24 Participants n=24 Participants
Presentation at metastatic diagnosis Recurrent MBC	41 Participants n=14 Participants	39 Participants n=10 Participants	80 Participants n=24 Participants
ECOG PS at enrollment 0	38 Participants n=14 Participants	31 Participants n=10 Participants	69 Participants n=24 Participants
ECOG PS at enrollment 1	14 Participants n=14 Participants	21 Participants n=10 Participants	35 Participants n=24 Participants

PRIMARY outcome

Timeframe: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024.

Population: A total of 110 patients were randomized. However, 6 out of 110 patients did not start treatment (4 did not meet eligibility, 1 withdrew consent prior to starting treatment, 1 died prior to starting treatment). Therefore a total of 104 patients that started treatment were analyzed.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Progression Free Survival	8.36 Months Interval 5.3 to 11.05	6.45 Months Interval 3.95 to 8.32

SECONDARY outcome

Timeframe: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Overall Response Rate (ORR) by RECIST 1.1

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Objective Response Rate	15 Participants	10 Participants

SECONDARY outcome

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing overall survival (OS), defined as the time from randomization (or registration) to death due to any cause with censoring at date last known alive, will be reported with Kaplan Meier estimates

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Overall Survival	20.0 Months Interval 16.9 to We don't have enough number of events to reliably estimate the upper CI	18.0 Months Interval 17.1 to 20.0

SECONDARY outcome

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing clinical benefit rate (CBR). CBR defined as CR, PR or stable disease for ≥ 24 weeks according to RECIST 1.1

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Clinical Benefit Rate	26 Participants	26 Participants

SECONDARY outcome

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing time to progression

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Time to Progression	8.36 Months Interval 5.3 to 12.5	6.68 Months Interval 3.95 to 8.68

SECONDARY outcome

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the duration of response (the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death due to any cause)

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 Participants The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Duration of Response	12.93 Months Interval 4.14 to We don't have enough number of events to reliably estimate the upper CI	4.51 Months Interval 4.47 to We don't have enough number of events to reliably estimate the upper CI

Adverse Events

Sacituzumab Govitecan + Pembrolizumab

Serious events: 40 serious events

Other events: 49 other events

Deaths: 18 deaths

Sacituzumab Govitecan

Serious events: 36 serious events

Other events: 48 other events

Deaths: 22 deaths

Serious adverse events

Other adverse events

Additional Information

Se Eun Kim

DFCI

Phone: 9196228080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 participants at risk The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 participants at risk The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Investigations Neutrophil count decreased	53.8% 28/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	46.2% 24/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations White blood cell decreased	23.1% 12/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Blood and lymphatic system disorders Anemia	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	9.6% 5/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Diarrhea	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Lymphocyte count decreased	11.5% 6/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Nausea	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	9.6% 5/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
General disorders Fatigue	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Vascular disorders Hypertension	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Blood and lymphatic system disorders Febrile neutropenia	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Platelet count decreased	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Sepsis	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Alanine aminotransferase increased	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Alkaline phosphatase increased	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Aspartate aminotransferase increased	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Blood bilirubin increased	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hypokalemia	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Vascular disorders Thromboembolic event	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Vomiting	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hyponatremia	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Colitis	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Eye disorders Blurred vision	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Lung infection	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Weight gain	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Weight loss	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Renal and urinary disorders Acute kidney injury	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Appendicitis	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Bacteremia	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Psychiatric disorders Confusion	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Ejection fraction decreased	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Cardiac disorders Heart failure	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.

Other adverse events
Measure	Sacituzumab Govitecan + Pembrolizumab n=52 participants at risk The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle	Sacituzumab Govitecan n=52 participants at risk The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
Investigations Neutrophil count decreased	15.4% 8/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	15.4% 8/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations White blood cell decreased	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Blood and lymphatic system disorders Anemia	28.8% 15/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	19.2% 10/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Diarrhea	17.3% 9/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	30.8% 16/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Lymphocyte count decreased	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Nausea	26.9% 14/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	23.1% 12/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
General disorders Fatigue	34.6% 18/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	28.8% 15/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Vascular disorders Hypertension	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Platelet count decreased	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Alanine aminotransferase increased	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Alkaline phosphatase increased	13.5% 7/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Investigations Aspartate aminotransferase increased	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hypokalemia	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Abdominal pain	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	13.5% 7/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Musculoskeletal and connective tissue disorders Back pain	9.6% 5/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.6% 5/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hypophosphatemia	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	9.6% 5/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Skin and subcutaneous tissue disorders Pruritus	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Skin and subcutaneous tissue disorders Alopecia	44.2% 23/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	38.5% 20/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Anorexia	11.5% 6/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	17.3% 9/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Constipation	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Respiratory, thoracic and mediastinal disorders Cough	9.6% 5/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Gastroesophageal reflux disease	9.6% 5/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Nervous system disorders Headache	3.8% 2/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Metabolism and nutrition disorders Hypoalbuminemia	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Endocrine disorders Hypothyroidism	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Infections and infestations	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Injury, poisoning and procedural complications Infusion related reaction	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Psychiatric disorders Insomnia	11.5% 6/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Gastrointestinal disorders Mucositis oral	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Musculoskeletal and connective tissue disorders Myalgia	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
General disorders Pain	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Sinusitis	1.9% 1/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Upper respiratory infection	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	11.5% 6/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Infections and infestations Urinary tract infection	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	5.8% 3/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.
Nervous system disorders Dysgeusia	0.00% 0/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.	7.7% 4/52 • AEs were collected from enrollment to end of treatment (SG was administered until progression; pembrolizumab was administered until progression or a max. of 35 doses (24 months) was reached, whichever occurred first). End of treatment visit (SG +/- pembrolizumab) was to occur within 45 days of final administration of study treatment. Additionally, AE assessment was performed 90 days (-15/+30 days) after the last dose of pembrolizumab. As of 3/9/24 data cutoff, the max. follow-up was 26 months. For mortality information, all patients that were randomized (n=110) were included as the denominator. For other AE information, only those that started treatment (n=104) are included as the denominator. As of data cutoff of 3/9/2024, the maximum follow-up duration is 26 months.