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Combining oregovomab with chemotherapy for advanced ovarian cancer treatment

A Phase 2, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial Comparing Chemoimmunotherapy (Paclitaxel-Carboplatin-Oregovomab) Versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) as Neoadjuvant Therapy in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma

Phase 2 Interventional CanariaBio Inc. · NCT05605535

This study is testing if adding a new immunotherapy called oregovomab to standard chemotherapy can help people with newly diagnosed advanced ovarian cancer feel better and improve their treatment results.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment88 (estimated)
Ages18 Years and up
SexFemale
SponsorCanariaBio Inc. Industry-sponsored
Drugs / interventionsoregovomab, bevacizumab, chemotherapy, immunotherapy, prednisone
Locations16 sites (Visakhapatnam, Andhra Pradesh and 15 other locations)
Trial IDNCT05605535 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of oregovomab, an immunotherapy agent, in conjunction with standard chemotherapy (paclitaxel and carboplatin) for patients with newly diagnosed advanced epithelial ovarian cancer. The study is a Phase 2, double-blind, placebo-controlled, multi-center trial that involves administering oregovomab or placebo at specific cycles of chemotherapy prior to interval debulking surgery. Approximately 96 patients will be screened, with around 88 expected to be randomized into the treatment groups, allowing for a thorough assessment of the treatment's impact on disease progression and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18 and older with newly diagnosed FIGO Stage III or IV epithelial ovarian, fallopian tube, or peritoneal cancer.

Not a fit: Patients with non-epithelial ovarian cancers or those who do not meet the specified health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced ovarian cancer.

How similar studies have performed: While there have been studies exploring immunotherapy in ovarian cancer, the specific combination of oregovomab with chemotherapy in this neoadjuvant setting is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adult females 18 years old or older.
2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV patients whose disease is confirmed based on biopsy sample.
3. Eligible histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
4. Suitable venous access for the study-required procedures.
5. Serum CA125 levels ≥ 50 U/mL prior to Cycle 1 of NACT chemotherapy + oregovomab or placebo.
6. Adequate bone marrow function:

   1. Absolute neutrophil count (ANC) ≥ 1,500/μL.
   2. Platelets ≥100,000/μL.
   3. Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before the first dose of study treatment).
7. Adequate liver function:

   1. Bilirubin \< 1.5 times upper limit normal (ULN).
   2. SGOT/AST and SGPT/ALT \< 2.5 times ULN.
8. Adequate renal function:

   a. Creatinine ≤ 1.5 times ULN.
9. ECOG Performance Status of 0, 1 or 2.
10. Women of childbearing potential must be willing to avoid pregnancy by using a highly effective method of contraception from the first dose of study treatment to 6 months after last dose of study treatment.
11. Signed written informed consent form and authorization permitting release of personal health information. Ability to comply with treatment and follow up

Exclusion Criteria:

1. Patients with mucinous adenocarcinoma, carcinosarcoma, tumors with neuroendocrine features and low-grade adenocarcinoma (including low grade serous and FIGO grade 1 endometrioid adenocarcinomas of the ovary).
2. FIGO Stage IV patients:

   1. FIGO stage IV patients suspected or diagnosed with bone or brain metastasis are excluded.
   2. FIGO stage IV patients diagnosed with lung and/or liver metastasis with tumour size more than 2 cm are excluded.
   3. FIGO stage IV patients diagnosed with lung and/or liver metastasis and expected to administer with more than 3 cycles of chemotherapy and/or not suitable for interval debulking surgery are excluded.
3. Patients must not have received any prior chemotherapy, immunotherapy, targeted or hormonal therapy.
4. Patients who are lactating and breastfeeding or have a positive serum pregnancy test within 14 days prior to the first dose of study treatment.
5. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study treatment according to this protocol.
6. Active autoimmune disease such as rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, or ankylosing spondylitis, requiring active disease modifying treatment.
7. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
8. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc.
9. Chronic therapeutic corticosteroid use, defined as \> 5 days of prednisone or equivalent, except for inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.)
10. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
11. Clinically significant active infection(s) at the time of screening.
12. Any of the following conditions (on-study testing is not required):

    1. Known HIV-infected patients unless on effective anti-retroviral therapy with an undetectable viral load within 6 months prior to randomization, or
    2. Known or suspected hepatitis B if active infection (patients with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or
    3. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load.
13. Uncontrolled or life-threatening diseases compromising safety evaluation. Diagnosed or treated for another malignancy within 5 years before the first dose, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer, ductal carcinoma in-situ (DCIS) of the breast or cervix carcinoma in situ are not excluded if they have undergone complete resection. a. Synchronous endometrial cancer, but a prior diagnosis of endometrial cancer within 5 years is not excluded if all of the following conditions are met: Stage IA, superficial myometrial invasion, without lymphovascular invasion, and not poorly differentiated subtypes including papillary serous, clear cell or other FIGO Grade II and III lesions.

15. Contraindication to the use of pressor agents. 16. Undergone prior surgical debulking. 17. History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases. 18. Any of the following cardiovascular conditions:

1. Acute myocardial infarction within 6 months before the first dose of study treatment.
2. Current history of New York Heart Association (NYHA) Class III or IV heart failure
3. Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings. 19. Unable to read or understand or unable to sign the necessary written consent before starting treatment. 20. May not receive any live, attenuated vaccine administered within 28 days (or 4 weeks) prior to enrollment, during the study, and for at least 90 days after the last dose of study treatment. 21. Patients who will receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), any other anti-cancer medications, including bevacizumab, PARPi, or any other investigational agent(s) with 3 cycles of paclitaxel and carboplatin neo-adjuvant treatment will be excluded.

Where this trial is running

Visakhapatnam, Andhra Pradesh and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian Neoplasm EpithelialOvarian CancerFallopian Tube NeoplasmsPeritoneal CarcinomaOvarian Serous AdenocarcinomaOvarian cancerPhase 2Oregovomab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.