Trial Outcomes & Findings for Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy (NCT NCT03199040)

NCT ID: NCT03199040

Last Updated: 2024-05-28

Results Overview

* Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. * Assessment of the safety of neoantigen DNA vaccines will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

90 days after completion of treatment (approximately day 259)

Results posted on

2024-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Neoantigen DNA Vaccine + Durvalumab * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days
Overall Study STARTED	9	9
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Neoantigen DNA Vaccine + Durvalumab * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days
Overall Study Lack of Efficacy	2	0
Overall Study Withdrawal by Subject	2	0
Overall Study Adverse Event	0	1
Overall Study Only completed 5 out of 6 vaccines	0	1

Baseline Characteristics

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neoantigen DNA Vaccine + Durvalumab n=9 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine n=9 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days	Total n=18 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	9 participants n=93 Participants	9 participants n=4 Participants	18 participants n=27 Participants
Age, Continuous	54 years n=93 Participants	58 years n=4 Participants	54.5 years n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants

PRIMARY outcome

Timeframe: 90 days after completion of treatment (approximately day 259)

Outcome measures

Outcome measures
Measure	Neoantigen DNA Vaccine + Durvalumab n=9 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine n=9 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 anemia	3 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 chest pain-cardiac	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 palpitations	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 hypothyroidism	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 visual migraine	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 abdominal cramps	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 constipation	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 diarrhea	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 dyspepsia	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 gastritis	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 nausea	2 Participants	3 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 vomiting	1 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 ankle edema	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 chills	2 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 edema limbs	1 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 fatigue	3 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 fever	1 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 flu-like symptoms	1 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 injection site pain	9 Participants	9 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 localized edema	2 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 neck edema	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 COVID-19 infection	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 infection from cat bite	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 oral herpes lesions	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 port infection	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 upper respiratory infection	2 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 urinary tract infection	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 wound infection	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 broken foot	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 bruising	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 fall	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 spinal fracture	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 3-5 vascular access complication	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 alanine aminotransferase increased	1 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 lymphocyte count decreased	1 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 3-5 lymphocyte count decreased	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 neutrophil count decreased	0 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 weight gain	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 weight loss	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 white blood cell decreased	0 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 anorexia	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 hyperglycemia	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 hyperkalemia	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 hypokalemia	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 hyponatremia	1 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 arthralgia	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 bone pain	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 myalgia	7 Participants	7 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 neck pain	2 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 pain in extremity	1 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 dizziness	3 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 headache	1 Participants	2 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 neuralgia	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 peripheral sensory neuropathy	2 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 insomnia	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 breast pain	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 vaginal dryness	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 allergic rhinitis	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 chest congestion	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 cough	1 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 dyspnea	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 rhinorrhea	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 sore throat	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 blanching of fingers on left hand	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 candidal rash	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 eczema	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 nail changes	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 nodule on breast	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 rash maculo-papular	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 skin hyperpigmentation	0 Participants	1 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 bilateral breast fat grafting	1 Participants	0 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 hypertension	2 Participants	3 Participants
Safety of Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Number of Adverse Events Experienced by Patient Grade 1-2 lymphedema	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 1 year after completion of treatment (approximately 1 year and 141 days)

Population: The luminex assay was not able to be performed.

-Peripheral blood will be collected at multiple time points before and after vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year after completion of treatment (approximately 1 year and 141 days)

Population: 4 participants in the Neoantigen DNA vaccine + Durvalumab arm were not evaluable due to early withdrawal from treatment (2=lack of efficacy, 2=withdrawal by subject). 2 participants in the Neoantigen DNA vaccine arm were not evaluable due to early withdrawal from treatment (1=adverse event, 1=only 5 out of 6 vaccines received).

The ELISpot assay was performed after in vitro culture of patient PBMC with neoantigen peptide for \~12 days. The number of spot-forming T cells, a surrogate for the number of neoantigen-specific T cells, was determined after neoantigen peptide re-stimulation for the duration of the assay (48 hours) and compared to that of control cells that were not re-stimulated with neoantigen during the assay. One-way anova analysis was performed on replicate assessments.

Outcome measures

Outcome measures
Measure	Neoantigen DNA Vaccine + Durvalumab n=5 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine n=7 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days
Number of Participants With an Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Interferon-gamma ELISPOT Assay	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 1 year after completion of treatment (approximately 1 year and 141 days)

Multiparametric flow cytometry was performed as a second readout to assess neoantigen-specific T cell reactivity. Markers included CD4, CD8, IFNγ, and a viability marker. After culture, as described above, T cells were stimulated for 6 hours with/without neoantigen and stained with fluorescent antibodies specific for the various markers. Data were analyzed by comparing the percentage IFNγ+ CD4/CD8 cells between neoantigen-stimulated vs unstimulated T cells; a \>2-fold increase in percentage positive cells after neoantigen stimulation was considered positive.

Outcome measures

Outcome measures
Measure	Neoantigen DNA Vaccine + Durvalumab n=5 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine n=7 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days
Number of Participants With Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Multiparametric Flow Cytometry - CD4	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 1 year after completion of treatment (approximately 1 year and 141 days)

Outcome measures

Outcome measures
Measure	Neoantigen DNA Vaccine + Durvalumab n=5 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine n=7 Participants * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days
Number of Participants With Immune Response to Neoantigen DNA Vaccines Given Alone or in Combination With Durvalumab as Measured by Multiparametric Flow Cytometry - CD8	3 Participants	5 Participants

Adverse Events

Neoantigen DNA Vaccine + Durvalumab

Serious events: 0 serious events

Other events: 9 other events

Deaths: 1 deaths

Neoantigen DNA Vaccine

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Williams Gillanders, M.D.

Washington University School of Medicine

Phone: 314-747-0072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Neoantigen DNA Vaccine + Durvalumab n=9 participants at risk * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days * For patients who are randomized to the neoantigen DNA vaccine plus durvalumab arm, the neoantigen-specific T cell response will be assessed prior to Day 85. If a neoantigen-specific T cell response is present, durvalumab will be started on Day 85, and will be administered Q4W at a dose of 1500 mg over the course of 60 minutes. If a neoantigen-specific T cell response is not present, these patients will be replaced but may continue to receive the neoantigen DNA vaccine on study. They will not be transferred to the vaccine-only arm.	Neoantigen DNA Vaccine n=9 participants at risk * The first neoantigen DNA vaccine injection will take place following the completion of standard of care therapy. The day of the first vaccine injection will be referred to as Day 1 * The schedule of vaccination is Day 1, Day 29 ± 7, Day 57 ± 7, Day 85 ± 7, Day 113 ± 7, and Day 141 ± 7 with at least 21 days between injection days
Blood and lymphatic system disorders Anemia	33.3% 3/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Cardiac disorders Chest pain-cardiac	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Cardiac disorders Palpitations	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Endocrine disorders Hypothyroidism	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Eye disorders Visual migraine	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Gastrointestinal disorders Abdominal cramps	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Gastrointestinal disorders Constipation	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Gastrointestinal disorders Diarrhea	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Gastrointestinal disorders Gastritis	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Gastrointestinal disorders Nausea	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	33.3% 3/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Gastrointestinal disorders Vomiting	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Ankle edema	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Chills	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Edema limbs	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Fatigue	33.3% 3/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Fever	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Flu-like symptoms	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Injection site pain	100.0% 9/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	100.0% 9/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Localized edema	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
General disorders Neck edema	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Infections and infestations COVID-19 infection	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Infections and infestations Infection from cat bite	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Infections and infestations Oral herpes lesions	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Infections and infestations Port infection	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Infections and infestations Upper respiratory infection	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Infections and infestations Urinary tract infection	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Infections and infestations Wound infection	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Injury, poisoning and procedural complications Broken foot	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Injury, poisoning and procedural complications Bruising	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Injury, poisoning and procedural complications Fall	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Injury, poisoning and procedural complications Spinal fracture	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Investigations Alanine aminotransferase increased	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Investigations Lymphocyte count decreased	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	33.3% 3/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Investigations Neutrophil count decreased	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Investigations Weight gain	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Investigations Weight loss	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Investigations White blood cell decreased	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	22.2% 2/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).
Metabolism and nutrition disorders Anorexia	0.00% 0/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).	11.1% 1/9 • Adverse events were collected from start of treatment through 90 days after completion of treatment (median follow-up 242 days, full range 132-300 days). All-cause mortality is collected from start of treatment through completion of follow-up (follow-up was a total of 1378 days).