Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin (ORION-02)
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|ClinicalTrials.gov Identifier: NCT04620954|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2020
Last Update Posted : December 9, 2020
This is an open-label, single-arm, phase I/II, single-center study with dose finding and dose expansion parts.
This study hypothesizes that the combination of platinum-based chemotherapy, Oregovomab and Nivolumab will improve intracellular CA 125 antigen processing and elicit a stronger systemic CA 125-specific T cell response and that it will be in a manner that is synergistic, safe and clinical efficacious in patients with relapsed platinum sensitive epithelial ovarian carcinoma (EOC).
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer||Drug: Oregovomab Drug: Nivolumab Drug: Chemotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Clinical Trial to Evaluate Platinum-based Chemotherapy, Oregovomab and Nivolumab in Patients With Platinum Sensitive Recurrent Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin|
|Actual Study Start Date :||October 7, 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
2mg of Oregovomab is administered through IV on Weeks 1, 5, 9, 17.
480mg of Nivolumab is administered through IV every 4 weeks (Weeks 9, 13, 17, 21).
Pegylated liposomal doxorubicin (PLD) and carboplatin are administered every 4 weeks through IV. The starting dose of PLD and carboplatin are 30mg/m^2 and 5 AUC (Area Under the Curve) respectively.
- Number of incidences of adverse events (AE) [ Time Frame: From time of start of treatment to the date of disease progression or death due to any cause, up to 2 years ]
- Proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) [ Time Frame: From time of start of treatment to CR or PR, up to 2 years ]Objective response rate
- Proportion of patients with best overall response of CR, PR, or Stable Disease (SD) [ Time Frame: From time of start of treatment to CR, PR or SD, up to 2 years ]Disease control rate
- Progression free survival [ Time Frame: From time of start of treatment to first documented progression or death due to any cause, up to 2 years ]
- Overall survival [ Time Frame: From time of start of treatment to time of death due to any cause, up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620954
|National Cancer Center Singapore|
|Singapore, Singapore, 169690|
|Principal Investigator:||Jack Chan, MD||National Cancer Centre, Singapore|