Specification of the application site (groin and axillary areas) for DCVAC/OvCa; specification of ChT toxicity management based on institutional standards or applicable national/European oncology guidelines; specification of pretreatment assessment of infection markers, if required by local/national regulations; correction of scheduling the leukapheresis procedure and prolongation of the time frame for the transport of the cells harvested during the leukapheresis procedure to the processing facility; specification of time points of the follow-up clinic visits and CA125 assessment.

Specification of methods of contraception (exclusion criterion 13); added justification of the DCVAC/OvCa dose; added definition of slow progressive disease; added information about continuation of DCVAC/OvCa administration after disease progression; specification that not only the medications must be recorded, but the doses taken/administered as well; added information regarding using a historical heart and lung X ray scan obtained prior to study entry; specification of the exclusion criterion 6 (previous or concurrent radiotherapy to the abdomen and pelvis).

Prolongation of screening period from originally up to 2 weeks to up to 4 weeks; specification of the follow-up period including definition of the EoT visit, efficacy follow-up, and survival follow up; specification of methods of contraception (exclusion criterion 13); change of inclusion criterion 3 (radiologically confirmed relapse after >6 months of remission (Pt-sensitive patients) to be found instead of originally up 2 to up to 4 weeks prior to study entry); changed the AE reporting period; definition and collection of SADRs; added determination of the sample size; added specification for patients’ replacement.

Change in randomization (to be performed within 4 weeks after screening instead of 2 weeks after screening); change in inclusion criteria 2 and 10 and in exclusion criteria 1 and 2; chest X-ray may be replaced by CT of thorax at the investigator’s decision; central reading no longer needed for evaluation of a patient’s eligibility; specification that pregnant women must pass the EoT visit; correction in follow-up procedures in the Schedule of assessments; an independent blinded radiologist to evaluate CT/MRI scans for sensitivity analyses of PFS and ORR.

Prolongation of the overall study duration by approximately 2 years as caused by extension of survival follow-up; the study is to be terminated after a sufficient number of events have been observed to evaluate mature OS. The main goal is that at least 50% of the total evaluable patients should have had a survival event. However, longer survival follow-up can be decided if deemed medically/statistically appropriate at the time of reaching the median survival (for the total group of patients in the study, i.e., without any separate study arm analysis). The item will be discussed with the trial SC (main investigators from the clinical trials SOV01, SOV02, SOV03, and a representative for the Polish sites) and the trial DMC for their recommendation to the sponsor regarding the length of the survival follow-up. Change in the frequency of telephone contacts during the survival follow-up period from 12 weeks to 6 months. Central reading of CT/MRI scans is to be considered only in case of a positive outcome of the analyses of the local evaluations or in case of a deemed need for health authority interactions. Addition of information on pharmacogenomics studies on research samples, which is relevant only for the Czech Republic (for operational reasons). (Pharmacogenomics research was approved as an addendum to the Protocol, version 4.1, in the Czech Republic. The sponsor added the already approved wording to the relevant part of the Protocol).