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Ovarian Neoplasm EpithelialPhase 2NCT05605535

Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer

A Phase 2 study testing Oregovomab, Paclitaxel and Carboplatin in people with Ovarian Neoplasm Epithelial and Ovarian Cancer, run by CanariaBio Inc. at 14 sites in India.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A clinical study to compare the efficacy and safety of five administrations of oregovomab versus placebo, infused in schedule dependent sequence with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of patients with newly diagnosed advanced ovarian cancer who… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Oregovomab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
14 sitesIndia
Study dates
7 Feb 2023to 15 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult females 18 years old or older.
  • 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.
  • 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.).
  • Suitable venous access for the study-required procedures.
  • Serum CA125 levels ≥ 50 U/mL prior to Cycle 1 of NACT chemotherapy + oregovomab or placebo.
  • Adequate bone marrow function:
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  • Absolute neutrophil count (ANC) ≥ 1,500/μL.
  • Platelets ≥100,000/μL.
  • Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before the first dose of study treatment).
  • Adequate liver function:
  • Bilirubin < 1.5 times upper limit normal (ULN).
  • SGOT/AST and SGPT/ALT < 2.5 times ULN.
  • Adequate renal function:
  • Creatinine ≤ 1.5 times ULN.
  • ECOG Performance Status of 0, 1 or 2.
  • 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.
  • Signed written informed consent form and authorization permitting release of personal health information. Ability to comply with treatment and follow up

Who cannot join

  • 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).
  • FIGO Stage IV patients:
  • FIGO stage IV patients suspected or diagnosed with bone or brain metastasis are excluded.
  • FIGO stage IV patients diagnosed with lung and/or liver metastasis with tumour size more than 2 cm are excluded.
  • 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.
  • Patients must not have received any prior chemotherapy, immunotherapy, targeted or hormonal therapy.
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  • Patients who are lactating and breastfeeding or have a positive serum pregnancy test within 14 days prior to the first dose of study treatment.
  • 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.
  • Active autoimmune disease such as rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, or ankylosing spondylitis, requiring active disease modifying treatment.
  • Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
  • Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc.
  • 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.)
  • Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
  • Clinically significant active infection(s) at the time of screening.
  • Any of the following conditions (on-study testing is not required):
  • Known HIV-infected patients unless on effective anti-retroviral therapy with an undetectable viral load within 6 months prior to randomization, or
  • 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
  • Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load.
  • 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:
  • Acute myocardial infarction within 6 months before the first dose of study treatment.
  • Current history of New York Heart Association (NYHA) Class III or IV heart failure
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

India14 sites

  • KLES Dr. Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, Karnataka, 590010

  • Saveetha Medical College and Hospitals

    Chennai, Tamil Nadu, 602105

  • Sri Ramchandra Medical Centre

    Chennai, Tamil Nadu

  • MNJ Cancer Hospital

    Hyderabad, Telangana, 500004

  • Sri Ram Cancer Hospital

    Jaipur, Rajasthan, 302022

  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682041

  • King Georges Medical University

    Lucknow, Uttar Pradesh, 226003

  • JIPMER

    Puducherry, Puducherry, 605006

  • Regional Cancer Centre, Medical College

    Trivandrum, Kerala, 695011

  • Himalaya Cancer Hospital and Research Institute

    Vadodara, Gujarat

  • Kailash Cancer Hospital and Research Centre

    Vadodara, Gujarat

  • Institute of Medical Sciences, BHU

    Varanasi, Uttar Pradesh, 221005

  • Omega Hospitals

    Visakhapatnam, Andhra Pradesh, 530040

  • King George Hospital

    Visakhapatnam, Andhra Pradesh

Other trials in India

About this study

Official title: 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

A clinical study to compare the efficacy and safety of five administrations of oregovomab versus placebo, infused in schedule dependent sequence with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of patients with newly diagnosed advanced ovarian cancer who are planned to receive neoadjuvant treatment followed by interval debulking surgery (IDS) and adjuvant treatment.

Read the detailed description

Phase 2, double-blind, placebo-controlled, multi-center study to compare the efficacy and safety of five administrations of oregovomab 2 mg IV versus placebo, infused in a schedule dependent sequence with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of patients with newly diagnosed advanced ovarian cancer who are planned to receive neoadjuvant treatment. Patients will receive oregovomab or placebo at Cycles 1 and 3 in combination with paclitaxel and carboplatin prior to IDS, followed by oregovomab or placebo at Cycles 4 and 6 in combination with paclitaxel and carboplatin, and oregovomab or placebo monotherapy at Cycle 6 plus 12 weeks.

This study will screen approximately 96 patients to randomize approximately 88 patients. All eligible patients will be stratified by FIGO Stage (Stages IIIA, IIIB versus Stages IIIC, IV).

The study includes screening period, treatment period, post-treatment follow up, safety follow and long term follow up.

Being tested
Oregovomab, Paclitaxel, Carboplatin, Placebo
Keywords
Ovarian cancer, Phase 2, Oregovomab, Chemoimmunotherapy
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OregovomabBiological

    Also called MAb-B43.13

    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes

  • PaclitaxelDrug

    Also called Taxol

    175 mg/m^2, every 3 weeks

  • CarboplatinDrug

    Also called Paraplatin

    AUC 5 or 6 IV Day 1 x 6 cycles (every 21 days)

  • PlaceboBiological

    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes

Study groups in NCT05605535
Study groupRoleWhat they receive
Combination of Oregovomab and chemotherapyExperimentalSix (6) cycles of chemotherapy with oregovomab given only at specific cycles (Cycle 1, Cycle 3, Cycle 4, Cycle 6 and Cycle 6 plus 12 weeks).
Receives: Biological: Oregovomab; Drug: Paclitaxel; Drug: Carboplatin
Combination of Placebo and chemotherapyPlacebo comparatorSix (6) cycles of chemotherapy with placebo given only at specific cycles (Cycle 1, Cycle 3, Cycle 4, Cycle 6 and Cycle 6 plus 12 weeks).
Receives: Drug: Paclitaxel; Drug: Carboplatin; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) Rate at 12 months

    PFS, is assessed from date of randomization to the date of first documented progression as per RECIST v1.1 as determined by the investigator or death due to any cause.

    Measured: At 12 months

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    Overall response rate is defined according to RECIST v1.1 measured at end of first 3 cycles of study treatment and prior to debulking surgery treatment:

    • Complete response
    • Partial Response

    Measured: At 3 months

  2. Disease Control Rate (DCR):

    Disease control rate is defined according to RECIST v1.1 measured at end of first 3 cycles of treatment and prior to debulking surgery treatment:

    • Complete response
    • Partial Response
    • Stable Disease

    Measured: At 3 months

  3. Response to Surgery

    Upon completion of neo-adjuvant treatment and IDS, Response to surgery will be assessed on the size of residual disease - none (R0), < 1 cm (R1), ≥ 1 cm (R2)

    Measured: At 4 months

  4. Progression Free Survival

    Progression free survival is defined as date of randomization to date of first documented progression as per RECIST v1.1 as determined by the investigator or death due to any cause and OS defined as date of randomization to date of death due to any cause.

    Measured: Approximately up to 4 years

  5. Overall Survival

    Overall survival is defined as date of randomization to date of death due to any cause.

    Measured: Approximately up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start7 Feb 2023
  3. Primary completion15 May 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605535
Sponsor's protocol ID
QPT-ORE-006
Status last verified
Oct 2026
First submitted
25 Oct 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brewer M, Angioli R, Scambia G, Lorusso D, Terranova C, Panici PB, Raspagliesi F, Scollo P, Plotti F, Ferrandina G, Salutari V, Ricci C, Braly P, Holloway R, Method M, Madiyalakan M, Bayever E, Nicodemus C. Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study. Gynecol Oncol. 2020 Mar;156(3):523-529. doi: 10.1016/j.ygyno.2019.12.024. Epub 2020 Jan 6.

    PubMed 31916979

  • Braly P, Nicodemus CF, Chu C, Collins Y, Edwards R, Gordon A, McGuire W, Schoonmaker C, Whiteside T, Smith LM, Method M. The Immune adjuvant properties of front-line carboplatin-paclitaxel: a randomized phase 2 study of alternative schedules of intravenous oregovomab chemoimmunotherapy in advanced ovarian cancer. J Immunother. 2009 Jan;32(1):54-65. doi: 10.1097/CJI.0b013e31818b3dad.

    PubMed 19307994

  • Berek J, Taylor P, McGuire W, Smith LM, Schultes B, Nicodemus CF. Oregovomab maintenance monoimmunotherapy does not improve outcomes in advanced ovarian cancer. J Clin Oncol. 2009 Jan 20;27(3):418-25. doi: 10.1200/JCO.2008.17.8400. Epub 2008 Dec 15.

    PubMed 19075271

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oregovomab, Paclitaxel and Carboplatin in people with Ovarian Neoplasm Epithelial and Ovarian Cancer, run by CanariaBio Inc. at 14 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) Rate at 12 months (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605535, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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