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oregovomab

Phase 2

Ovarian Neoplasms | Monoclonal antibody | Oncology |Quest Diagnostics Inc.|Last Updated: Sep 14, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

Clinical trial landscape

oregovomab · 1 trial · 1 indication

Phase 2 1
NCT01616303A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian CancerOvarian Neoplasms
COMPLETED97 Analytics
PHASE2COMPLETED
A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer
Ovarian NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy
At Baseline (up to 4 weeks before Cycle 1), at Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1)

Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy

Secondary Endpoints

Time to clinical relapse
Up to three years after treatment in the study
Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity)
Up to three years after treatment in the study
Clinical response
Up to three years after treatment in the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
carboplatin & paclitaxelACTIVE_COMPARATORfirst-line chemotherapy for ovarian cancer
carboplatin & paclitaxel & oregovomabEXPERIMENTALfirst-line chemotherapy for ovarian cancer plus oregovomab

Interventions

NameTypeDescription
CarboplatinDRUGcarboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks \[21 days\])
PaclitaxelDRUGPaclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks \[21 days\])
oregovomabBIOLOGICALoregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
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Eligibility Criteria

Age Range18 Years to 75 Years
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage III/IV disease. * have preoperative CA125 levels \> 50 U/mL * have optimal cytoreduction (RT\<1) * be anticip...

Countries:United States
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Frequently asked questions about oregovomab

What is oregovomab used for?

Oregovomab is a monoclonal antibody being studied for the treatment of ovarian neoplasms, specifically advanced ovarian cancer. It is currently in Phase 2 clinical development and is intended for use in combination with chemotherapy for this patient population.

What does oregovomab target?

Oregovomab is a monoclonal antibody that targets CA-125, a tumor-associated antigen commonly expressed in ovarian cancer. By binding to CA-125, it is designed to elicit an immune response against cancer cells expressing this antigen.

Who is developing oregovomab?

Oregovomab is being developed by Quest Diagnostics Inc., a company publicly traded under the ticker symbol DGX. The company is conducting clinical trials to evaluate the drug's effectiveness in treating advanced ovarian cancer.

What phase is oregovomab in?

Oregovomab is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed to assess its efficacy in combination with chemotherapy for advanced ovarian cancer.

What clinical trials is oregovomab in?

Oregovomab has been studied in one clinical trial, NCT01616303, titled 'A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer.' This Phase 2 trial enrolled 97 female participants aged 18 years and older in the United States and has been completed.

Is oregovomab the same as any other drug?

Oregovomab is also known by its developmental code name. It is a monoclonal antibody that specifically targets CA-125, and it is being investigated as a potential treatment for ovarian cancer. No other alternative names have been reported for this drug.