Trial Outcomes & Findings for Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma (NCT NCT03338959)

NCT ID: NCT03338959

Last Updated: 2024-07-23

Results Overview

Necrosis greater than or equal to 90% at pathologic assessment at time of surgery

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: From baseline through wound care follow-up visit (up to 8 months)
• Results posted on: 2024-07-23

Participant Flow

Participant milestones

Measure	Treatment (Pembrolizumab, Radiation Therapy) Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy
Overall Study STARTED	27
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	Treatment (Pembrolizumab, Radiation Therapy) Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy
Overall Study Patients remain in Long-Term Follow-Up	17
Overall Study Physician Decision	1

Baseline Characteristics

Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma

Baseline characteristics by cohort

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=27 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy
Age, Customized Aged Under 18 at Enrollment	0 Participants n=5 Participants
Age, Customized Aged 18-29 at Enrollment	1 Participants n=5 Participants
Age, Customized Aged 30-39 at Enrollment	1 Participants n=5 Participants
Age, Customized Aged 40-49 at Enrollment	2 Participants n=5 Participants
Age, Customized Aged 50-59 at Enrollment	4 Participants n=5 Participants
Age, Customized Aged 60-69 at Enrollment	9 Participants n=5 Participants
Age, Customized Aged 70 and Above at Enrollment	10 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline through wound care follow-up visit (up to 8 months)

Population: 24 out of 27 participants evaluable for the primary endpoint. 4 participants experienced necrosis greater than 90%.

Necrosis greater than or equal to 90% at pathologic assessment at time of surgery

Outcome measures

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=24 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy	Grade 2 Events Treatment-related Grade 2 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 3 Events Treatment-related Grade 3 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 4 Events Treatment-related Grade 4 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 5 Events Treatment-related Grade 5 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.
Rate of Complete Tumor Necrosis	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Through the wound care follow-up visit (up to 8 months)

Population: All participants evaluable for adverse events.

Treatment-related adverse events (AEs) experienced by participants evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and determined to be possibly related, probably related, or definitely related to either pembrolizumab therapy, radiation therapy, or both.

Outcome measures

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=27 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy	Grade 2 Events n=27 Participants Treatment-related Grade 2 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 3 Events n=27 Participants Treatment-related Grade 3 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 4 Events n=27 Participants Treatment-related Grade 4 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 5 Events n=27 Participants Treatment-related Grade 5 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.
Incidence of Adverse Events Dermatitis Radiation	12 events experienced	7 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Fatigue	11 events experienced	3 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Rash maculo-papular	5 events experienced	3 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Diarrhea	5 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Tumor pain	2 events experienced	2 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Lymphocyte count decreased	0 events experienced	3 events experienced	1 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Wound dehiscence	2 events experienced	1 events experienced	1 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Hypothyroidism	0 events experienced	4 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Nausea	1 events experienced	2 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Pain in extremity	1 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Anorexia	1 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Anemia	0 events experienced	1 events experienced	1 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Bullous dermatitis	2 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Skin and subcutaneous disorders - Other - Erythema	2 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Dizziness	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Alanine aminotransferase increased	0 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Aspartate aminotransferase increased	0 events experienced	0 events experienced	1 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Pneumothorax	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Dry skin	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Pruritus	0 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Dehydration	0 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Weight loss	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Peripheral sensory neuropathy	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Cough	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Hypokalemia	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Peripheral ischemia	0 events experienced	0 events experienced	0 events experienced	1 events experienced	0 events experienced
Incidence of Adverse Events Chest wall pain	0 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Blood and lymphatic system disorders - Other - Eosinophil count increased	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Thyroid Stimulating Hormone Increased	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Rectal pain	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Wound infection	0 events experienced	0 events experienced	1 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Localized edema	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Urinary urgency	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Pelvic pain	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Urinary retention	0 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Thromboembolic event	0 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Hypomagnesemia	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Vaginal hemorrhage	0 events experienced	0 events experienced	1 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Skin and subcutaneous disorders - Other - Rash	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Edema limbs	2 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Neuralgia	1 events experienced	0 events experienced	0 events experienced	0 events experienced	0 events experienced
Incidence of Adverse Events Colitis	0 events experienced	1 events experienced	0 events experienced	0 events experienced	0 events experienced

SECONDARY outcome

Timeframe: From baseline through wound care follow-up visit (up to 8 months)

Population: 26 out of 27 participants evaluable for this endpoint.

Proportion of patients who achieved a partial response based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=26 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy	Grade 2 Events Treatment-related Grade 2 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 3 Events Treatment-related Grade 3 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 4 Events Treatment-related Grade 4 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 5 Events Treatment-related Grade 5 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.
Partial Response Rate	0.08 proportion of participants Interval 0.01 to 0.25	—	—	—	—

SECONDARY outcome

Timeframe: From baseline through wound care follow-up visit (up to 8 months)

Population: 26 out of 27 participants evaluable for this endpoint.

Rate of disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm as defined per RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=26 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy	Grade 2 Events Treatment-related Grade 2 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 3 Events Treatment-related Grade 3 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 4 Events Treatment-related Grade 4 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 5 Events Treatment-related Grade 5 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.
Complete Response Rate	0.00 proportion of participants Interval 0.0 to 0.13	—	—	—	—

SECONDARY outcome

Timeframe: From baseline through wound care follow-up visit (up to 8 months)

Population: 26 out of 27 participants evaluable for this endpoint.

Rate of participants who experienced a Complete Response (CR) + Partial Reponse (PR) as defined per RECIST v1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=26 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy	Grade 2 Events Treatment-related Grade 2 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 3 Events Treatment-related Grade 3 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 4 Events Treatment-related Grade 4 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.	Grade 5 Events Treatment-related Grade 5 Adverse Events (AEs) experienced by participants as defined by CTCAE 5.0 criteria.
Overall Response Rate	0.08 proportion of participants Interval 0.01 to 0.25	—	—	—	—

Adverse Events

Treatment (Pembrolizumab, Radiation Therapy)

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=27 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy
Gastrointestinal disorders Abdominal Pain	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Investigations Aspartate aminotransferase increased	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Colonic perforation	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Psychiatric disorders Delirium	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Gastrointestinal disorders - Other	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Psychiatric disorders Hallucinations	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Lung infection	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Nausea	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Vascular disorders Peripheral ischemia	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Presyncope	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Injury, poisoning and procedural complications Wound dehiscence	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Infections and infestations Wound infection	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.

Other adverse events

Measure	Treatment (Pembrolizumab, Radiation Therapy) n=27 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy
General disorders Fatigue	63.0% 17/27 • Number of events 18 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Injury, poisoning and procedural complications Dermatitis Radiation	51.9% 14/27 • Number of events 16 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Diarrhea	40.7% 11/27 • Number of events 11 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Nausea	33.3% 9/27 • Number of events 9 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Anorexia	29.6% 8/27 • Number of events 8 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Pain in extremity	22.2% 6/27 • Number of events 8 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Skin and subcutaneous tissue disorders Rash maculo-papular	18.5% 5/27 • Number of events 9 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Constipation	18.5% 5/27 • Number of events 5 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Presyncope	14.8% 4/27 • Number of events 4 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Cough	18.5% 5/27 • Number of events 5 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Metabolism and nutrition disorders Hypomagnesemia	18.5% 5/27 • Number of events 5 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Injury, poisoning and procedural complications Wound dehiscence	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	14.8% 4/27 • Number of events 5 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Endocrine disorders Hypothyroidism	14.8% 4/27 • Number of events 4 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Investigations Lymphocyte count decreased	11.1% 3/27 • Number of events 7 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Skin and subcutaneous tissue disorders Dermatitis Radiation	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Skin and subcutaneous tissue disorders Dry Skin	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Skin and subcutaneous tissue disorders Pruritus	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
General disorders Edema Limbs	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Abdominal Pain	3.7% 1/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Neuralgia	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Psychiatric disorders Anxiety	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Back pain	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Vascular disorders Hypotension	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Blood and lymphatic system disorders Anemia	11.1% 3/27 • Number of events 5 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Metabolism and nutrition disorders Hypokalemia	11.1% 3/27 • Number of events 3 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Skin and subcutaneous tissue disorders Bullous dermtitis	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
General disorders Pain	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Vomiting	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Dizziness	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Dysgeusia	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Sore throat	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Psychiatric disorders Confusion	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Muscle cramp	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Vascular disorders Thromboembolic event	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Infections and infestations Urinary tract infection	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Eye disorders Blurred vision	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Renal and urinary disorders Urinary retention	7.4% 2/27 • Number of events 2 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Investigations Alanine aminotransferase increased	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Investigations Thyroid stimulating hormone increased	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Investigations Weight loss	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Skin and subcutaneous tissue disorders Eczema	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
General disorders Fever	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
General disorders Injection site reaction	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
General disorders Irritability	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
General disorders Localized edema	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
General disorders Non-cardiac chest pain	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Colitis	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Dyspepsia	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Dysphagia	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Enterocolitis	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Esophageal obstruction	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Gastrointestinal disorders Rectal pain	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Headache	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Memory impairment	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Peripheral sensory neuropathy	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Nervous system disorders Phantom pain	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Injury, poisoning and procedural complications Bruising	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Injury, poisoning and procedural complications Fall	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Injury, poisoning and procedural complications Seroma	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Apnea	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Phemothorax	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Psychiatric disorders Insomnia	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Arthralgia	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Arthritis	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Buttock pain	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Chest wall pain	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Cardiac disorders Sinus bradycardia	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Investigations Investigations - Other	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Infections and infestations Gum infection	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Infections and infestations Sinusitis	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Infections and infestations Upper respiratory infection	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Infections and infestations Vaginal infection	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Metabolism and nutrition disorders Dehydration	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Renal and urinary disorders Dysuria	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Renal and urinary disorders Urinary frequency	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Renal and urinary disorders Urinary urgency	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Reproductive system and breast disorders Pelvic pain	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Reproductive system and breast disorders Vaginal hemorrhage	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Endocrine disorders Hyperthyroidism	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Immune system disorders Allergic reaction	3.7% 1/27 • Number of events 1 • All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months) Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.

Additional Information

Lee Cranmer, MD, PhD, Sarcoma Program Director

University of Washington

Phone: 206-606-7439

Email: ldcranme@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60