Trial Outcomes & Findings for Ovarian Cancer Vaccine for Patients in Remission (NCT NCT01068509)

Last Updated: 2017-05-11

Results Overview

Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Non-randomized Cvac Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained \~ 60 × 10\^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.	Randomized Cvac Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care Participants in this group did not receive any treatment during the study.
Overall Study STARTED	7	29	27
Overall Study COMPLETED	1	7	6
Overall Study NOT COMPLETED	6	22	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-randomized Cvac Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained \~ 60 × 10\^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.	Randomized Cvac Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care Participants in this group did not receive any treatment during the study.
Overall Study Death	0	0	1
Overall Study Disease Progression	5	20	18
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrew Consent	0	1	2
Overall Study Reason Not Specified	0	1	0

Baseline Characteristics

Ovarian Cancer Vaccine for Patients in Remission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-randomized Cvac n=7 Participants Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained \~ 60 × 10\^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.	Randomized Cvac n=29 Participants Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care n=27 Participants Participants in this group did not receive any treatment during the study.	Total n=63 Participants Total of all reporting groups
Age, Continuous	52.4 Years STANDARD_DEVIATION 10.3 • n=5 Participants	56.8 Years STANDARD_DEVIATION 8.5 • n=7 Participants	56.2 Years STANDARD_DEVIATION 9.5 • n=5 Participants	56.1 Years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	63 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)

Population: Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.

Outcome measures

Outcome measures
Measure	Randomized Cvac n=29 Participants Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care n=27 Participants Participants in this group did not receive any treatment during the study.
Progression-free Survival	12.89 Months Interval 7.26 to 22.77	8.64 Months Interval 4.66 to 18.33

SECONDARY outcome

Timeframe: Baseline to the end of the study (up to 4 years 10 months)

Population: Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.

Overall survival was defined as the time from randomization until death from any cause.

Outcome measures

Outcome measures
Measure	Randomized Cvac n=29 Participants Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care n=27 Participants Participants in this group did not receive any treatment during the study.
Overall Survival	NA Months The median (95% Confidence Interval) could not be calculated due to too few deaths.	NA Months The median (95% Confidence Interval) could not be calculated due to too few deaths.

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.

Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.

Outcome measures

Outcome measures
Measure	Randomized Cvac n=29 Participants Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care n=27 Participants Participants in this group did not receive any treatment during the study.
Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104 Week 104 (n's=10, 10)	-203.0 Arbitrary units Standard Deviation 4413.4	-1956.7 Arbitrary units Standard Deviation 5711.1
Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104 Week 20 (n's=21, 13)	957.2 Arbitrary units Standard Deviation 9127.3	-2854.8 Arbitrary units Standard Deviation 9411.8
Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104 Week 56 (n's=8, 6)	-1113.9 Arbitrary units Standard Deviation 12033.3	-19063.1 Arbitrary units Standard Deviation 41323.7

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.

Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.

Outcome measures

Outcome measures
Measure	Randomized Cvac n=29 Participants Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care n=27 Participants Participants in this group did not receive any treatment during the study.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IFNg in CD4+ cells (n's=2, 2)	-1.2676 Arbitrary units Standard Deviation 0.4039	-1.2676 Arbitrary units Standard Deviation 0.4039
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IL2 in CD8+ cells (n's=2, 2)	-0.9438 Arbitrary units Standard Deviation 0.0057	-0.9438 Arbitrary units Standard Deviation 0.0057
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IL4 in CD8+ cells (n's=2, 2)	0.0622 Arbitrary units Standard Deviation 0.0950	-0.0622 Arbitrary units Standard Deviation 0.0950
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IL17 in CD8+ cells (n's=2, 2)	-0.0396 Arbitrary units Standard Deviation 0.0136	-0.0396 Arbitrary units Standard Deviation 0.0136
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: TNF in CD8+ cells (n's=2, 2)	-5.8027 Arbitrary units Standard Deviation 3.2811	-5.8027 Arbitrary units Standard Deviation 3.2811
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IFNg in CD8+ cells (n's=2, 2)	-5.9300 Arbitrary units Standard Deviation 3.7024	-5.9300 Arbitrary units Standard Deviation 3.7024
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IL2 in CD4+ cells (n's=3, 1)	-2.3179 Arbitrary units Standard Deviation 1.8772	-1.4545 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IL2 in CD4+ cells (n's=21, 14)	-1.4022 Arbitrary units Standard Deviation 0.9730	-1.1842 Arbitrary units Standard Deviation 1.0945
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IL4 in CD4+ cells (n's=21, 14)	-0.0702 Arbitrary units Standard Deviation 0.3781	-0.1651 Arbitrary units Standard Deviation 0.2876
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IL17 in CD4+ cells (n's=21, 14)	-1.0544 Arbitrary units Standard Deviation 1.1481	-0.3960 Arbitrary units Standard Deviation 0.4052
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: TNF in CD4+ cells (n's=21, 14)	-2.7106 Arbitrary units Standard Deviation 2.1428	-1.8939 Arbitrary units Standard Deviation 1.7481
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IFNg in CD4+ cells (n's=21, 14)	-1.3576 Arbitrary units Standard Deviation 1.5922	-1.0243 Arbitrary units Standard Deviation 1.2047
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IL2 in CD8+ cells (n's=21, 14)	-0.3724 Arbitrary units Standard Deviation 0.3808	-0.4562 Arbitrary units Standard Deviation 0.5527
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IL4 in CD8+ cells (n's=21, 14)	-0.1495 Arbitrary units Standard Deviation 0.1218	-0.5607 Arbitrary units Standard Deviation 1.4552
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IL17 in CD8+ cells (n's=21, 14)	-0.8268 Arbitrary units Standard Deviation 1.6737	-0.1232 Arbitrary units Standard Deviation 0.1367
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: TNF in CD8+ cells (n's=21, 14)	-2.0802 Arbitrary units Standard Deviation 2.0004	-1.9156 Arbitrary units Standard Deviation 2.1254
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 20: IFNg in CD8+ cells (n's=21, 14)	-2.8385 Arbitrary units Standard Deviation 2.5259	-2.3178 Arbitrary units Standard Deviation 2.1022
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IL2 in CD4+ cells (n's=2, 2)	-1.6798 Arbitrary units Standard Deviation 2.1394	-1.6798 Arbitrary units Standard Deviation 2.1394
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IL4 in CD4+ cells (n's=2, 2)	-0.3824 Arbitrary units Standard Deviation 0.1417	-0.3824 Arbitrary units Standard Deviation 0.1417
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: IL17 in CD4+ cells (n's=2, 2)	-0.9413 Arbitrary units Standard Deviation 0.6249	-0.9413 Arbitrary units Standard Deviation 0.6249
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 56: TNF in CD4+ cells (n's=2, 2)	-5.9500 Arbitrary units Standard Deviation 3.3064	-5.9500 Arbitrary units Standard Deviation 3.3064
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IL4 in CD4+ cells (n's=3, 1)	-0.3328 Arbitrary units Standard Deviation 0.1972	-0.2912 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IL17 in CD4+ cells (n's=3, 1)	-1.1783 Arbitrary units Standard Deviation 0.5970	-1.0044 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: TNF in CD4+ cells (n's=3, 1)	-6.4140 Arbitrary units Standard Deviation 2.3691	-2.9642 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IFNg in CD4+ cells (n's=3, 1)	-1.3833 Arbitrary units Standard Deviation 0.3474	-1.5452 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IL2 in CD8+ cells (n's=3, 1)	-1.1586 Arbitrary units Standard Deviation 0.3643	-0.1277 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IL4 in CD8+ cells (n's=3, 1)	-0.1241 Arbitrary units Standard Deviation 0.0688	-0.1282 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IL17 in CD8+ cells (n's=3, 1)	-0.2485 Arbitrary units Standard Deviation 0.3395	-0.4682 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: TNF in CD8+ cells (n's=3, 1)	-5.1697 Arbitrary units Standard Deviation 2.6055	-1.6795 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104 Week 104: IFNg in CD8+ cells (n's=3, 1)	-5.1340 Arbitrary units Standard Deviation 3.0755	-2.3506 Arbitrary units Standard Deviation NA The standard deviation could not be calculated as there was only 1 participant.

Adverse Events

Non-randomized Cvac

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Randomized Cvac

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

Observational Standard of Care

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-randomized Cvac n=7 participants at risk Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained \~ 60 × 10\^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.	Randomized Cvac n=26 participants at risk Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.	Observational Standard of Care n=24 participants at risk Participants in this group did not receive any treatment during the study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/7 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	7.7% 2/26 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	0.00% 0/24 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).
Gastrointestinal disorders Abdominal pain	0.00% 0/7 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	3.8% 1/26 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	0.00% 0/24 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).
General disorders Disease progression	0.00% 0/7 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	3.8% 1/26 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	0.00% 0/24 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/7 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	3.8% 1/26 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	0.00% 0/24 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).
Reproductive system and breast disorders Ovarian epithelial cancer metastatic	0.00% 0/7 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	3.8% 1/26 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).	0.00% 0/24 Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).

Other adverse events

Additional Information

Marc Voigt

PrimaBioMed, Ltd.

Phone: 49 173 6771602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For study centers in Australia, no publication of the study results may be made until publication of the results of the study from all centers or until 2 years after study completion, whichever is sooner. For study centers in the USA, no submission for publication or public disclosure of the results by will be made until the results from all centers have been received and analyzed by the sponsor, or the multi-center study has been terminated or abandoned at all centers.
Publication restrictions are in place

Restriction type: OTHER