Trial Outcomes & Findings for Talabostat and Pembrolizumab for the Treatment of Advanced Solid Cancers (NCT NCT04171219)

NCT ID: NCT04171219

Last Updated: 2025-05-16

Results Overview

Disease control rate was defined as the percentage of patients who had complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
• Results posted on: 2025-05-16

Participant Flow

This is an open-label, single-institution, Phase 2 study of BXCL701 administered orally and daily, combined with pembrolizumab, in PD1/PDL1 or CTLA-4 naïve and PD1/PDL1 or CTLA-4 pretreated patients with advanced solid cancers at The University of Texas MD Anderson Cancer Center.

Participant milestones

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Overall Study STARTED	14	17
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	14	17

Reasons for withdrawal

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Overall Study Adverse Event	1	0
Overall Study Death	0	1
Overall Study Lack of Efficacy	9	13
Overall Study Withdrawal by Subject	1	2
Overall Study Clinical PD and extended treatment holding/ Patient choice/withdrew consent	1	1
Overall Study Clinical PD/Patient choice	1	0
Overall Study Toxicity/ Patient choice	1	0

Baseline Characteristics

Talabostat and Pembrolizumab for the Treatment of Advanced Solid Cancers

Baseline characteristics by cohort

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=14 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=17 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years

Population: To be evaluable for response, patients must have completed at least 9 weeks of treatment and received at least 70% of the total planned talabostat dose in cycles 1 and 2.

Disease control rate was defined as the percentage of patients who had complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.

Outcome measures

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=9 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=10 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Disease Control Rate Per RECIST v1.1	4 Participants	4 Participants

PRIMARY outcome

Timeframe: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years

Population: To be evaluable for response, patients must have completed at least 9 weeks of treatment and received at least 70% of the total planned talabostat dose in cycles 1 and 2.

Immune-related disease control rate was defined as the percentage of patients who had immune-related complete response (iCR), immune-related partial response (iPR), or immune-related stable disease (iSD) according to iRECIST.

Outcome measures

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=9 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=10 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Immune-related Disease Control Rate Per iRECIST	4 Participants	5 Participants

PRIMARY outcome

Timeframe: DLT was assessed during Cycle 1 (21-day cycle)

Population: DLT was assessed in the first 6 patients enrolled on the study. Unless doses were held because of DLT, a patient must have received \>70% of their BXCL701 in Cycle 1 (i.e., ≥30 of 42 planned doses) with pembrolizumab dosed on Day 1 of Cycle 1

A DLT was defined as any of the following AEs occurring during Cycle 1, regardless of investigator attribution to study treatment:

• Any Grade 4 laboratory abnormality, regardless of duration.
• Any Grade 3 laboratory abnormalities if associated with clinical symptoms regardless of duration
• Any Grade ≥3 non-hematologic AE, with the exceptions of Grade ≥3 nausea, vomiting, diarrhea, constipation, and fatigue, that resolves to Grade ≤1 within 72 hours with optimal medical management and/or supportive measures.
• Grade ≥3 thrombocytopenia with Grade >1 bleeding or requirement for platelet transfusion.
• Grade ≥3 febrile neutropenia.
• Grade ≥3 fever.
• Grade ≥3 skin rash.
• AST or ALT >3 × upper limit of normal [ULN] with concomitant total bilirubin >2 × ULN.
• Any toxicity resulting in ≥30% held/skipped doses of BXCL701 during Cycle 1.
• Delay of Cycle 2 by ≥14 days due to toxicity.
• Any other significant toxicity considered by the investigatoro be dose-limiting.

Outcome measures

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=2 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=4 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Dose-limiting Toxicities (DLTs)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years

Population: To be evaluable for response, patients must have completed at least 9 weeks of treatment and received at least 70% of the total planned talabostat dose in cycles 1 and 2.

PFS was defined as the time from administration of the first dose to the first documented disease progression by RECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.

Outcome measures

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=9 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=10 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Progression-free Survival (PFS) by RECIST v1.1	2.7 Months Interval 1.9 to 7.8	2.5 Months Interval 2.1 to 6.5

SECONDARY outcome

Timeframe: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years

Population: To be evaluable for response, patients must have completed at least 9 weeks of treatment and received at least 70% of the total planned talabostat dose in cycles 1 and 2.

PFS was defined as the time from administration of the first dose to the first documented disease progression by iRECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.

Outcome measures

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=9 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=10 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Progression-free Survival (PFS) by iRECIST	2.7 Months Interval 1.9 to 7.8	2.5 Months Interval 2.1 to 6.5

SECONDARY outcome

Timeframe: From the first date of administration of the study drug to the date of data cut-off (January 7, 2024)

Population: To be evaluable for response, patients must have completed at least 9 weeks of treatment and received at least 70% of the total planned talabostat dose in cycles 1 and 2.

Overall survival was measured from the first date of administration of the study drug to the date of death due to any cause. Patients who were alive at the last follow-up examination were censored.

Outcome measures

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=9 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=10 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Overall Survival (OS)	16.4 Months Interval 4.4 to 30.1	26.1 Months Interval 8.6 to not estimated

SECONDARY outcome

Timeframe: Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years.

Population: All patients who received at least one dose of study drug were included in safety analysis.

All safety data from all patients, who received at least one dose of study drug were included in safety analysis. Each AE (as defined by NCI CTCAE v5) was counted only once for a given subject. In the event a patient experienced repeated episodes of the same AE, then the event with the highest severity and/or strongest causal relationship to study treatment was used for purposes of tabulations.

Outcome measures

Measure	Cohort A: PD-1/PD-L1 and/or CTLA-4 Inhibitor Treatment naïve n=14 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days	Cohort B: PD-1/PD-L1 and/or CTLA-4 Inhibitor Pretreated n=17 Participants BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Treatment-related Adverse Event (TRAE)	10 Participants	9 Participants

Adverse Events

All Patients Treated on This Study.

Serious events: 17 serious events

Other events: 29 other events

Deaths: 26 deaths

Serious adverse events

Measure	All Patients Treated on This Study. n=31 participants at risk BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Gastrointestinal disorders Abdominal pain	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Back pain	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Vascular disorders Hypotension	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Creatinine increased	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Edema limbs	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Fever	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Diarrhea	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Cough	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hyperglycemia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Abdominal distension	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Infections and infestations Lung infection	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Non-cardiac chest pain	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Pain	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Syncope	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Infections and infestations Vulval infection	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.

Other adverse events

Measure	All Patients Treated on This Study. n=31 participants at risk BXCL701: 0.3 mg orally twice a day on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg administered IV on Day 1 every 21 days
Vascular disorders Hypotension	25.8% 8/31 • Number of events 8 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.6% 7/31 • Number of events 7 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Pain	22.6% 7/31 • Number of events 7 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Fatigue	19.4% 6/31 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders General disorders and administration site conditions - Other, specify	19.4% 6/31 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Blood and lymphatic system disorders Anemia	16.1% 5/31 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Abdominal pain	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Diarrhea	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Edema limbs	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Fever	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hypercalcemia	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Nausea	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Renal and urinary disorders Renal and urinary disorders - Other, specify	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Vomiting	12.9% 4/31 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Back pain	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Constipation	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Cough	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Injury, poisoning and procedural complications Fall	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hyperglycemia	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Vascular disorders Hypertension	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hyponatremia	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Platelet count decreased	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	9.7% 3/31 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Abdominal distension	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Anorexia	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Aspartate aminotransferase increased	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Creatinine increased	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hyperkalemia	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Endocrine disorders Hypothyroidism	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Blood and lymphatic system disorders Leukocytosis	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Infections and infestations Lung infection	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Neutrophil count decreased	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Peripheral sensory neuropathy	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Skin and subcutaneous tissue disorders Pruritus	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Syncope	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations White blood cell decreased	6.5% 2/31 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Alanine aminotransferase increased	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Ascites	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Eye disorders Blurred vision	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Cardiac disorders Cardiac disorders - Other, specify	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Infections and infestations Catheter related infection	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Dizziness	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Dysphagia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Skin and subcutaneous tissue disorders Erythema multiforme	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Eye disorders Eye disorders - Other, specify	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Injury, poisoning and procedural complications Fracture	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Gastroesophageal reflux disease	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Generalized edema	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Glucose intolerance	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Headache	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hyperlipidemia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hyperphosphatemia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hypoalbuminemia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Metabolism and nutrition disorders Hypoglycemia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Infections and infestations Infections and infestations - Other, specify	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Psychiatric disorders Insomnia	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Vascular disorders Lymphedema	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Lymphocyte count decreased	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Muscle cramp	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
General disorders Non-cardiac chest pain	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Peripheral motor neuropathy	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Psychiatric disorders Psychiatric disorders - Other, specify	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Skin and subcutaneous tissue disorders Rash acneiform	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Seizure	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Nervous system disorders Spinal cord compression	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Gastrointestinal disorders Stomach pain	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Infections and infestations Upper respiratory infection	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Renal and urinary disorders Urinary retention	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Eye disorders Vision decreased	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Infections and infestations Vulval infection	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.
Investigations Weight gain	3.2% 1/31 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years. All AEs were reported to regulatory authorities and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs to the IND Office, within 5 working days and all life-threatening or fatal events, unexpected and drug-related within 24 hours of knowledge of the event to the Safety Project Manager in the IND Office. Percentages are calculated using the number of patients in the safety population as the denominator.

Additional Information

Aung Naing, MD

M.D. Anderson Cancer Center

Phone: 713-563-3885

Email: anaing@mdanderson.org

Results disclosure agreements

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