Trial Outcomes & Findings for Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer (NCT NCT02865135)

Last Updated: 2024-01-11

Results Overview

A DLT was defined as any grade 3 or greater adverse event at least possibly related to the study agent including injection site reactions; or grade 2 or greater allergic reactions which occur in a subject prior to day 50, will trigger DLT. In addition, to be considered as DLT, the adverse event must be considered at least possibly related to study treatment. Grade 3 or greater abnormal lab values lasting \<= 72 hours might be excluded as DLTs if there are no accompanying clinical signs and symptoms per investigator's discretion.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Patients were followed for 50 days.

Results posted on

2024-01-11

Participant Flow

Participants enrolled from 3/30/17 until 9/10/19.

Participant milestones

Participant milestones
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Overall Study STARTED	6	3	2
Overall Study Evaluable for T Cell Analysis	6	3	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Overall Study Death	0	1	0
Overall Study Progression	6	2	2

Baseline Characteristics

Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 Participants Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] n=2 Participants Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.	Total n=11 Participants Total of all reporting groups
Age, Continuous	52.5 years STANDARD_DEVIATION 11.9 • n=5 Participants	54.1 years STANDARD_DEVIATION 9.29 • n=7 Participants	69.5 years STANDARD_DEVIATION 1.76 • n=5 Participants	56.1 years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Score (ECOG PS) ECOG PS0	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Score (ECOG PS) ECOG PS1	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Score (ECOG PS) ECOG PS2	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Site of Disease Anal	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Site of Disease Cervical	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Site of Disease Oropharyngeal	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Patients were followed for 50 days.

Outcome measures

Outcome measures
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1b]	0 Participants	—	—

PRIMARY outcome

Timeframe: The median follow up was 2.92 months (range 1.25 - 5.88months).

The proportion of participants who experienced grade 1-2 treatment-related adverse events based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) as reported on case report forms.

Outcome measures

Outcome measures
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 Participants Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] n=2 Participants Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Grade 1-2 Treatment-Related AE Rate	0.66 proportion of participants Interval 0.22 to 0.96	1 proportion of participants Interval 0.01 to 1.0	1 proportion of participants Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: Patients were followed 22 days.

Population: Data were not collected for participants who registered after amendment 10.

'Responders' will be defined as patients with at least a two-fold increase in the number of CD 8+ T cells (dextramer, ELISpot or both methods) in the peripheral blood and tissue at the final analysis.

Outcome measures

Outcome measures
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 Participants Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue Responders	16.7 percentage of participants Interval 0.6 to 64.1	0 percentage of participants Interval 0.0 to 70.8	—
Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue Non-responder	83.3 percentage of participants Interval 35.9 to 99.6	100 percentage of participants Interval 29.2 to 100.0	—

SECONDARY outcome

Timeframe: The median follow up was 2.92 months (range 1.25 - 5.88months).

Best Overall Response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started) based on modified RECIST 1.1 and irRECIST. Per irRECIST, CR was defined as disappearance of all lesions in two consecutive observations not less than four weeks apart; PR was defined as greater than or equal to 50% decrease in tumor burden compared with baseline in two observations at least four weeks apart.

Outcome measures

Outcome measures
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 Participants Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] n=2 Participants Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Best Overall Response SD	2 Participants	1 Participants	0 Participants
Best Overall Response PD	4 Participants	1 Participants	2 Participants
Best Overall Response Unevaluable	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: The median follow up was 4.8 months (range 1.6 - 14.9 months).

Population: The analysis dataset is comprised of all enrolled participants.

Overall survival based on the Kaplan-Meier method is defined as the time the start of treatment to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.

Outcome measures

Outcome measures
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 Participants Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] n=2 Participants Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Median Overall Survival	16.5 Months Interval 1.8 to 16.5	4.8 Months Interval 3.7 to 5.9	NA Months Limited number of participants died during the time of observation.

SECONDARY outcome

Timeframe: The median follow up was 4.8 months (range 1.6 - 14.9 months).

Population: The analysis dataset is comprised of all enrolled participants

PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study or the appearance of one or more new lesions. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Outcome measures
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 Participants Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] n=2 Participants Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Median Progression-Free Survival	2.9 Months Interval 1.2 to 4.8	3.3 Months Interval 2.8 to 5.9	1.4 Months Interval 1.2 to 1.6

SECONDARY outcome

Timeframe: The median follow up was 4.8 months (range 1.6 - 14.9 months).

Population: The analysis dataset is comprised of all enrolled patients.

TTP is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Participants alive without PD were censored at the earliest of the date of the last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study or the appearance of one or more new lesions. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Outcome measures
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 Participants Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 Participants Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] n=2 Participants Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Time to Progression (TTP)	2.9 Months Interval 1.2 to 4.8	3.3 Months Interval 2.8 to 5.9	1.4 Months Interval 1.2 to 1.6

Adverse Events

DPX-E7 + Cyclophosphamide [Phase Ib Cohort]

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

DPX-E7 + Cyclophosphamide [Phase II Cohort 1]

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

DPX-E7 [Phase II Cohort 2]

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DPX-E7 + Cyclophosphamide [Phase Ib Cohort] n=6 participants at risk Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 + Cyclophosphamide [Phase II Cohort 1] n=3 participants at risk Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.	DPX-E7 [Phase II Cohort 2] n=2 participants at risk Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Cardiac disorders Myocardial infarction	0.00% 0/6 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/3 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	50.0% 1/2 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Death NOS	16.7% 1/6 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/3 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/2 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Fever	16.7% 1/6 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/3 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/2 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Infections and infestations Upper respiratory infection	0.00% 0/6 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/3 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	50.0% 1/2 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/3 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	50.0% 1/2 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/3 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	50.0% 1/2 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Vascular disorders Hypotension	0.00% 0/6 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	0.00% 0/3 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.	50.0% 1/2 • Adverse events were assessed from the time that participants signed consent and 30 days post treatment-end. Participants received a median (range) treatment duration in months 2.92 (1.25 - 5.88). Deaths were monitored until 14.9 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.

Other adverse events

Additional Information

Kartik Sehgal, MD

Dana Farber Cancer Institute (DFCI)

Phone: 617-632-3090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place