Trial Outcomes & Findings for A Study of Pembrolizumab And Platinum With Radiotherapy in Cervix Cancer (NCT NCT03144466)

Last Updated: 2026-05-20

Results Overview

To establish the maximum tolerated dose (MTD) of pembrolizumab that can be safely combined with radiotherapy, brachytherapy and cisplatin in the absence of dose limiting toxicities (DLTs)

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

Time from Treatment commencement date until 12 weeks following end of radiation treatment, up to 18 weeks

Results posted on

2026-05-20

Participant Flow

1 patient was recruited to the study at the Royal Marsden Hospital in the United Kingdom. The patient received 100mg of pembrolizumab with radiotherapy, brachytherapy and cisplatin.

During the period between December 2017 and October 2018, 1 patient was consented to the trial and received study treatment.

Participant milestones

Participant milestones
Measure	Part A - Starting Dose 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody
Overall Study STARTED	1	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - Starting Dose 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody
Overall Study Study termination	1	0	0

Baseline Characteristics

A Study of Pembrolizumab And Platinum With Radiotherapy in Cervix Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - Starting Dose n=1 Participants 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=30 Participants	—	—	1 Participants n=133 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Sex: Female, Male Female	1 Participants n=30 Participants	—	—	1 Participants n=133 Participants
Sex: Female, Male Male	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Race (NIH/OMB) White	1 Participants n=30 Participants	—	—	1 Participants n=133 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Region of Enrollment United Kingdom	1 participants n=30 Participants	—	—	1 participants n=133 Participants
Eastern Cooperative Oncology Group (ECOG) 0 = Normal activity. Fully active, able to carry on all pre-disease performance without restriction.	1 Participants n=30 Participants	—	—	1 Participants n=133 Participants
Eastern Cooperative Oncology Group (ECOG) 1 = Symptoms, but ambulatory.	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Eastern Cooperative Oncology Group (ECOG) 2 = In bed <50% of the time.	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Eastern Cooperative Oncology Group (ECOG) 3 = In bed > 50% of the time.	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Eastern Cooperative Oncology Group (ECOG) 4 = 100% bedridden.	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants
Eastern Cooperative Oncology Group (ECOG) 5 = Dead.	0 Participants n=30 Participants	—	—	0 Participants n=133 Participants

PRIMARY outcome

Timeframe: Time from Treatment commencement date until 12 weeks following end of radiation treatment, up to 18 weeks

Population: All patients registered on the starting and escalation dose parts A of the trial who have received at least on treatment dose. Only one patient treated with the starting dose and none treated in the escalation dose due to the early termination of the trial. Maximum Tolerated Dose was not established.

To establish the maximum tolerated dose (MTD) of pembrolizumab that can be safely combined with radiotherapy, brachytherapy and cisplatin in the absence of dose limiting toxicities (DLTs)

Outcome measures

Outcome measures
Measure	Part A - Starting Dose n=1 Participants 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody
Number and Percentage of Patients With Dose Limiting Toxicities.	0 Participants	—	—

SECONDARY outcome

Timeframe: Treatment commencement through study completion, up to 19 weeks after last dose of Pembrolizumab

Population: Patients who received at least one treatment dose in all parts of the study. Available data are reported in the table for the 1 patient treated in Part A starting dose. No patients recruited in the two other arms due to the trial early termination and no data reported in the table.

To evaluate acute toxicity as measured during treatment by CTCAE v4.0

Outcome measures

Outcome measures
Measure	Part A - Starting Dose n=1 Participants 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody
Evaluate Toxicities of Treatment Number of participants with grade 1 or more toxicities	1 Participants	—	—
Evaluate Toxicities of Treatment Number of patients with grade 2 or more toxicities	1 Participants	—	—

SECONDARY outcome

Timeframe: Assessments at week 5 and week 12 following end of radiation treatment

Population: All patients who received trial treatment and assessed for tumour response using RECIST 1.1 guidelines by physical examination, and tumour imaging by MRI with or without PET/CT. No patients recruited in the two other arms due to the trial early termination and no data reported in the table.

Counts of patients with CR/PR response. As per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Part A - Starting Dose n=1 Participants 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody
Response Rates Response at week 5 post RT	1 Participants	—	—
Response Rates Response at week 12 post RT	1 Participants	—	—

SECONDARY outcome

Timeframe: Time from treatment commencement date until 1 and 2 years assessments.

Population: All patients who consented and registered to participate in the trial. However, only one participant was enrolled, and the participant was in the study for 10 months, therefore, could not be assessed for this outcome measure at the pre-specified time points of 1 year and 2 years

To assess Overall Survival probability at 1 and 2 years post treatment start

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessment at 12 weeks following end of radiation therapy.

Population: Patients who received the combination (pembrolizumab combined with radiotherapy) treatment.

Percentage of patients with grade 1 plus late RTOG toxicity at 12 weeks post following radiation therapy (week 18)

Outcome measures

Outcome measures
Measure	Part A - Starting Dose n=1 Participants 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody
Late Radiotherapy Toxicity	0 Participants	—	—

SECONDARY outcome

Timeframe: Time from treatment commencement date until 1 and 2 years assessments.

Population: All patients who consented and registered to participate in the trial. However, Only one participant was enrolled, and the participant was in the study for 10 months, therefore, could not be assessed for this Outcome Measure at the pre-specified time points of 1 year and 2 years

To assess Progression Free Survival probability at 1 and 2 years

Outcome measures

Outcome data not reported

Adverse Events

Part A - Starting Dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A - Escalation Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B - Expansion Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A - Starting Dose n=1 participants at risk 100mg of pembrolizumab in n=3 patients, administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part A - Escalation Dose Escalation of dose to 200mg of pembrolizumab in a further n=3 patients provided no more than 1/6 patients at starting dose experience a DLT. Increase in cohort by three patients to n=6 patients provided no more than 1/3 patients experience a Dose Limiting Toxicity (DLT). Pembrolizumab: antiPD1 monoclonal antibody	Part B - Expansion Phase Recruitment of expansion cohort of n=14 patients using Maximum Tolerated Dose (MTD) of Pembrolizumab as determined in the dose escalation phase. MTD to be administered in 8 cycles every 3 weeks for a total of 18 weeks commencing two weeks prior to first fraction of radiotherapy and given in combination with Radical Radiotherapy, Brachytherapy and Cisplatin Chemotherapy. Pembrolizumab: antiPD1 monoclonal antibody
Ear and labyrinth disorders Tinnitus	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Eye disorders Blurred Vision	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Gastrointestinal disorders Gastritis	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 2 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Gastrointestinal disorders Abdominal Pain	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
General disorders Pain	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Investigations Neutrophil Count Decreased	100.0% 1/1 • Number of events 2 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Investigations Alanine Aminotransferase Increased	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Nervous system disorders Headache	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Reproductive system and breast disorders Vaginal Hemorrhage	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Reproductive system and breast disorders Dyspareunia	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.
Reproductive system and breast disorders Vaginal Discharge	100.0% 1/1 • Number of events 1 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.	— 0/0 • All adverse events were recorded from treatment commencement date until around 10 months when the single recruited participant had the last post treatment safety assessment. All-cause mortality were assessed during the same time frame. One patient recruited in the Part A Starting Dose arm. Adverse events experienced by this patients are reported in the tables. No patients were recruited to Part A Escalation Dose and Part B Expansion Phase due to early trial termination, therefore no adverse events were reported for these groups in the tables.

Additional Information

PAPAYA Senior Trial Manager

The Royal Marsden NHS Foundation Trust

Phone: (+44) 020 8915 6666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place