Trial Outcomes & Findings for PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck (NCT NCT02819752)

NCT ID: NCT02819752

Last Updated: 2025-12-18

Results Overview

To establish the maximum tolerated dose that can safely be combined with platin-based chemoradiotherapy in patients with HPV-ve and HPV+ve LA-SCCHN.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: Six weeks after the completion of chemoradiotherapy
• Results posted on: 2025-12-18

Participant Flow

During the period between July 2017 and July 2019, 3 patients were recruited to the study at the Royal Marsden Hospital in the United Kingdom.

Participant milestones

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab administered as a 30-minute infusion. Dose level 1: 100mg 3-weekly; dose level 2: 200mg 3-weekly. Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab administered as a 30-minute infusion. Dose level 1: 100mg 3-weekly; dose level 2: 200mg 3-weekly. Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Overall Study STARTED	0	3
Overall Study COMPLETED	0	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 Participants Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	Total n=3 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	—	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) White	—	3 Participants n=41 Participants	3 Participants n=88 Participants
Age, Categorical <=18 years	—	0 Participants n=41 Participants	0 Participants n=88 Participants
Age, Categorical Between 18 and 65 years	—	2 Participants n=41 Participants	2 Participants n=88 Participants
Age, Categorical >=65 years	—	1 Participants n=41 Participants	1 Participants n=88 Participants
Sex: Female, Male Female	—	1 Participants n=41 Participants	1 Participants n=88 Participants
Sex: Female, Male Male	—	2 Participants n=41 Participants	2 Participants n=88 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Asian	—	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=41 Participants	0 Participants n=88 Participants
Region of Enrollment United Kingdom	—	3 participants n=41 Participants	3 participants n=88 Participants
Eastern Cooperative Oncology Group (ECOG) 0 = Normal activity.	—	1 Participants n=41 Participants	1 Participants n=88 Participants
Eastern Cooperative Oncology Group (ECOG) 1 = Symptoms, but ambulatory.	—	2 Participants n=41 Participants	2 Participants n=88 Participants

PRIMARY outcome

Timeframe: Six weeks after the completion of chemoradiotherapy

Population: All patients registered on the trial and have received at least one treatment dose. Only three patients were treated with one of the doses and the trial terminated early. Maximum Tolerated Dose was not established.

To establish the maximum tolerated dose that can safely be combined with platin-based chemoradiotherapy in patients with HPV-ve and HPV+ve LA-SCCHN.

Outcome measures

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 Participants Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Number and Percentage of Patients With Dose Limiting Toxicities (DLT).	—	0 Participants

PRIMARY outcome

Timeframe: Up until 6 weeks after the end of chemoradiotherapy (week 14 of the study)

Population: All patients registered on the trial and have received at least one treatment dose.

Count and percentage of patients with any CTCAE graded toxicity from start of trial treatment until 6 weeks following end of treatment

Outcome measures

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 Participants Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Acute Toxicity as Measured During Treatment by CTCAE v4.0 Number of patients with any grade 2 or more toxicities	—	3 Participants
Acute Toxicity as Measured During Treatment by CTCAE v4.0 Number of patients with any grade 1 or more toxicities	—	3 Participants

SECONDARY outcome

Timeframe: Six months, one year and two years

Population: All patients registered on the trial and have received at least one treatment dose.

Calculated as percentage of evaluable patients alive and disease free at each time point.

Outcome measures

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 Participants Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Percentage of Progression Free Survival at 6, 12 and 24 Months Post Treatment Start. Number of patients progression free at 6 months	—	3 Participants
Percentage of Progression Free Survival at 6, 12 and 24 Months Post Treatment Start. Number of patient progression free at 12 months	—	3 Participants
Percentage of Progression Free Survival at 6, 12 and 24 Months Post Treatment Start. Number of patients progression free at 24 months	—	1 Participants

SECONDARY outcome

Timeframe: Six months, one year and two years

Population: All patients registered on the trial and have received at least one treatment dose.

Calculated as percentage of evaluable patients alive at each time point

Outcome measures

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 Participants Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Percentage of Overall Survival at 6, 12 and 24 Months Number of patients alive at 6 months	—	3 Participants
Percentage of Overall Survival at 6, 12 and 24 Months Number of patients alive at 12 months	—	3 Participants
Percentage of Overall Survival at 6, 12 and 24 Months Number of patients alive at 24 months	—	1 Participants

SECONDARY outcome

Timeframe: Six months, one year and two years

Population: All patients who consented and received trial treatment.

Calculated as percentage of evaluable patients with clinical benefit (CR/PR/SD) using RECIST at 6, 12 and 24 months

Outcome measures

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 Participants Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Percentage of Patients With Clinical Benefit (CR/PR/SD) Using RECIST at 6, 12 and 24 Months Number of patients with CR/PR/SD response at 12 months	—	3 Participants
Percentage of Patients With Clinical Benefit (CR/PR/SD) Using RECIST at 6, 12 and 24 Months Number of patients with CR/PR/SD response at 24 months	—	1 Participants
Percentage of Patients With Clinical Benefit (CR/PR/SD) Using RECIST at 6, 12 and 24 Months Number of patients with CR/PR/SD response at 6 months	—	3 Participants

SECONDARY outcome

Timeframe: 52 weeks from the end of radiation therapy (week 7)

Population: Patients who consented and received the combination therapy

Calculated as percentage of patients with any grade 1 toxicities from start of treatment up to 52 weeks from the end of radiotherapy.

Outcome measures

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 Participants Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Percentage of Patients With Any Grade 1 Plus RTOG Toxicities	—	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion (24 months)

Population: All patients who consented and received trial treatment. Data not available for this outcome, the planned laboratory work was not performed as the smaller than planned sample size meant this was not thought to be useful.

Mean biomarker levels in patients according to the categories of RECIST response CR/PR/SD vs PD).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, week 3, week 9 and week 15

Population: All patients who consented and received trial treatment. Data not available for this outcome, the planned laboratory work was not performed as the smaller than planned sample size meant this was not thought to be useful.

Description of circulating free tumour DNA levels by time to progression.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion (24 months)

Population: All patients who consented and received trial treatment. Data not available for this outcome, the planned laboratory work was not performed as the smaller than planned sample size meant this was not thought to be useful.

Description of laboratory findings from the immunohistochemical analysis of tissue samples.

Outcome measures

Outcome data not reported

Adverse Events

HPV-ve Stage IVA/IVB SCCHN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HPV+ve Stage IVA/IVB SCCHN

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 participants at risk Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Blood and lymphatic system disorders Febrile Neutropenia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Vomiting	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Nausea	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
General disorders Fever	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 4 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Metabolism and nutrition disorders Anorexia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.

Other adverse events

Measure	HPV-ve Stage IVA/IVB SCCHN Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment	HPV+ve Stage IVA/IVB SCCHN n=3 participants at risk Pembrolizumab and Chemoradiotherapy Pembrolizumab: Pembrolizumab Radiotherapy: Radiotherapy - Standard Treatment Chemotherapy: Chemotherapy - Standard Treatment
Blood and lymphatic system disorders Anemia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 5 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Ear and labyrinth disorders Tinnitus	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	100.0% 3/3 • Number of events 7 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Ear and labyrinth disorders Ear Pain	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Ear and labyrinth disorders Hearing Impaired	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Ear and labyrinth disorders Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Mucositis Oral	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	100.0% 3/3 • Number of events 6 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Dry Mouth	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	100.0% 3/3 • Number of events 8 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Oral Pain	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 3 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Constipation	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 3 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Dysphagia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Diarrhea	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Stomach Pain	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Gastritis	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Dyspepsia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 3 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Vomiting	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Gastrointestinal disorders Nausea	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
General disorders Flu Like Symptoms	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
General disorders Fatigue	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
General disorders Neck Edema	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
General disorders Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Infections and infestations Upper Respiratory Infection	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Infections and infestations Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Injury, poisoning and procedural complications Dermatitis Radiation	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	100.0% 3/3 • Number of events 5 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations Neutrophil Count Decreased	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations Platelet Count Decreased	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations Blood Bilirubin Increased	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations Alanine Aminotransferase Increased	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 5 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations Aspartate Aminotransferase Increased	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 3 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations GGT Increased	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 6 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations Alkaline Phosphatase	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Investigations Weight Loss	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Metabolism and nutrition disorders Hypokalemia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Metabolism and nutrition disorders Dehydration	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Musculoskeletal and connective tissue disorders Myalgia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Musculoskeletal and connective tissue disorders Trismus	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Musculoskeletal and connective tissue disorders Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 4 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Musculoskeletal and connective tissue disorders Neck Pain	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Nervous system disorders Dysgeusia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 4 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Nervous system disorders Headache	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Nervous system disorders Myelitis	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Nervous system disorders Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Psychiatric disorders Insomnia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	100.0% 3/3 • Number of events 3 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Psychiatric disorders Anxiety	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Psychiatric disorders Suicidal Ideation	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Reproductive system and breast disorders Premature Menopause	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Reproductive system and breast disorders Vaginal Dryness	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Sore Throat	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Hoarseness	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Laryngeal Inflammation	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Dyspnea	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Voice Alteration	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Respiratory, thoracic and mediastinal disorders Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Skin and subcutaneous tissue disorders Rash Maculo-papular	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 2 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Skin and subcutaneous tissue disorders Alopecia	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	66.7% 2/3 • Number of events 3 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Skin and subcutaneous tissue disorders Dry Skin	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Skin and subcutaneous tissue disorders Other	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Vascular disorders Lymphedema	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Injury, poisoning and procedural complications Bruising	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
Endocrine disorders Hypothyroidism	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.
General disorders Fever	— 0/0 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.	33.3% 1/3 • Number of events 1 • Adverse events were recorded from the first dose of pembrolizumab until the patients 12 weeks safety follow-up visit. No patients were recruited to HPV-ve arm, therefore no adverse events were reported for this arm.

Additional Information

PEACH Senior Trial Manager

The Royal Marsden NHS Foundation Trust

Phone: (+44) 02089156666

Email: peach.trial@rmh.nhs.uk

Results disclosure agreements

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