- |||||||||| OvaRex (oregovomab) / CanariaBio
P2 data, Journal: OPERA: a phase II trial of oregovomab plus non-platinum chemotherapy in PARP inhibitor/platinum-resistant ovarian cancer. (Pubmed Central) - Jun 28, 2024 P2 Herein, we described the rationale and design of OPERA/KGOG 3065/APGOT-OV6, a multicenter, investigator-initiated, two-cohort, single-arm phase II trial, aimed at examining the efficacy of oregovomab plus non-platinum-based chemotherapy in patients with PARPi/platinum-resistant ovarian cancer. The primary end point was the objective response rate, according to RECIST 1.1.Clinical Trial Registration: NCT05407584 (ClinicalTrials.gov).
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Biomarker, Preclinical, Journal, PARP Biomarker, PARP Companion diagnostic: The OVAREX study: Establishment of ex vivo ovarian cancer models to validate innovative therapies and to identify predictive biomarkers. (Pubmed Central) - Jun 8, 2024 P=N/A This clinical study aims at generating PDX and ex vivo models (PDTO, ADS, and explants) from tumors or ascites of ovarian cancer patients who will undergo surgical procedure or paracentesis. We aim at demonstrating the predictive value of ex vivo models for their potential use in routine clinical practice as part of precision medicine, as well as establishing a collection of relevant ovarian cancer models that will be useful for the evaluation of future innovative therapies.
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Enrollment closed, Trial primary completion date, Surgery, Metastases: FLORA-5: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (clinicaltrials.gov) - Jun 26, 2023 P3, N=615, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> May 2024 | Trial primary completion date: May 2023 --> Sep 2023 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2024 --> Sep 2025
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Oregovomab and non-platinum chemotherapy in PARP inhibitor-resistant ovarian, fallopian tube, or primary peritoneal cancer patients not candidates for platinum retreatment: A multicenter, two-cohort, single-arm phase 2 trial (OPERA/KGOG 3065/APGOT-OV6). (On Demand | Hall A; Poster Bd # 311b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2261; P2 The trial includes patients with recurrent EOC who have experienced disease progression despite treatment with PARPis and who have either received bevacizumab or are not eligible for bevacizumab treatment...Patients who have received one to three prior lines of chemotherapy are to be assigned to Cohort 1 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + pegylated liposomal doxorubicin [PLD] 40 mg/m2 q4w, n = 28), while patients who have received more than three prior lines of chemotherapy are to be assigned to Cohort 2 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + weekly paclitaxel 80 mg/m2 [D1,8,15 q4w], n = 28)...The study is registered with Clinicaltrials.gov (NCT05407584). Clinical trial information: NCT05407584.
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OREGOVOMAB AND NON-PLATINUM SINGLE AGENT CHEMOTHERAPY IN PARP INHIBITORRESISTANT OVARIAN CANCER PATIENTS NOT CANDIDATE FOR PLATINUM RETREATMENT: A MULTI-COHORT PHASE II STUDY (KGOG 3065/ APGOT-OV6) () - Sep 9, 2022 - Abstract #IGCS2022IGCS_1067; Patients were assigned to one of the followings: Cohort 1 (prior 1-3 lines of therapy), PLD (40 mg/m2 q4w till PD) + Oregovomab 2 mg (C1,2,3,5,7 for 5 doses) or Cohort 2 (>3 prior lines of therapy), weekly paclitaxel (80 mg/m2 D1,8,15 q4w till PD) + Oregovomab 2 mg (C1,2,3,5,7 for 5 doses). Trial in progress: there are no available results at the time of submission.
- |||||||||| OvaRex (oregovomab) / Quest PharmaTech
FLORA-5/GOG3035: Frontline chemo-immunotherapy (paclitaxel-carboplatin-oregovomab [PCO] versus chemotherapy (paclitaxel-carboplatin-placebo [PCP]) in patients with advanced epithelial ovarian cancer (EOC)—Phase III, double-blind, placebo-controlled, global, multinational study. (Available On Demand; 486a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5447; P3 The study is actively enrolling in the US, Canada, Belgium, Italy, Spain, Czech Republic, Hungary, Poland, Korea, Taiwan, Mexico, Argentina, and Chile. 179 patients were enrolled at time of submission.
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Journal: Oregovomab: an investigational agent for the treatment of advanced ovarian cancer. (Pubmed Central) - Feb 18, 2021 Since oral treatments as PARP-inhibitors have recently been approved in the OC first-line setting, the possible role of oregovomab needs still to be defined, also considering the intravenous route of administration. The easy to manage toxicity profile makes oregovomab an ideal candidate for association strategies.
- |||||||||| Opdivo (nivolumab) / BMS, OvaRex (oregovomab) / CanariaBio
Enrollment change, Trial completion date, Trial termination: ORION-01: Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin (clinicaltrials.gov) - Nov 12, 2020 P1/2, N=13, Terminated, Trial completion date: Sep 2021 --> Nov 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2021 --> Nov 2020; Sponsor Decision to discontinue long-term follow-up N=32 --> 13 | Trial completion date: Dec 2019 --> Apr 2020 | Recruiting --> Terminated; The study had poor efficacy.
- |||||||||| Viracept (nelfinavir) / ViiV Healthcare, Roche, OvaRex (oregovomab) / CanariaBio
Trial completion, Trial completion date, Metastases: Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer (clinicaltrials.gov) - Nov 15, 2019 P2, N=11, Completed, Re-evaluation with modern systemic paradigms is recommended. Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Dec 2018
- |||||||||| Viracept (nelfinavir) / ViiV Healthcare, Roche, OvaRex (oregovomab) / CanariaBio
Enrollment closed, Enrollment change, Trial primary completion date, Metastases: Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer (clinicaltrials.gov) - Apr 26, 2018 P2, N=12, Active, not recruiting, Trial primary completion date: Aug 2018 --> Sep 2021 Recruiting --> Active, not recruiting | N=66 --> 12 | Trial primary completion date: Dec 2018 --> Dec 2019
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