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

NCT05605535 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: QPT-ORE-006
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 14

Brief 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 are planned to receive neoadjuvant treatment followed by interval debulking surgery (IDS) and adjuvant treatment.

Conditions

Ovarian Neoplasm Epithelial; Ovarian Cancer; Fallopian Tube Neoplasms; Peritoneal Carcinoma; Ovarian Serous Adenocarcinoma

Keywords

Ovarian cancer; Phase 2; Oregovomab; Chemoimmunotherapy

Outcome Measures

Primary Outcomes (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.

  At 12 months

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  At 3 months

• Disease Control Rate (DCR):

  At 3 months

• Response to Surgery

  At 4 months

• Progression Free Survival

  Approximately up to 4 years

• Overall Survival

  Approximately up to 8 years

Study Arms (2)

Combination of Oregovomab and chemotherapy

EXPERIMENTAL

Six (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).

Biological: Oregovomab; Drug: Paclitaxel; Drug: Carboplatin

Combination of Placebo and chemotherapy

PLACEBO COMPARATOR

Six (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).

Drug: Paclitaxel; Drug: Carboplatin; Biological: Placebo

Interventions

Oregovomab BIOLOGICAL

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

Also known as: MAb-B43.13

Combination of Oregovomab and chemotherapy

Paclitaxel DRUG

175 mg/m\^2, every 3 weeks

Also known as: Taxol

Combination of Oregovomab and chemotherapy; Combination of Placebo and chemotherapy

Carboplatin DRUG

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

Also known as: Paraplatin

Combination of Oregovomab and chemotherapy; Combination of Placebo and chemotherapy

Placebo BIOLOGICAL

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

Combination of Placebo and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women 18 years of age and older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:
• a. Creatinine ≤ 1.5 times ULN.
• ECOG Performance Status of 0, 1 or 2.

You may not qualify if:

• 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.
• 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):

Sponsors & Collaborators

• CanariaBio Inc.: lead
• Raptim Research: collaborator

Study Sites (14)

Omega Hospitals

Visakhapatnam, Andhra Pradesh, 530040, India

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Location

Himalaya Cancer Hospital and Research Institute

Vadodara, Gujarat, India

Location

Kailash Cancer Hospital and Research Centre

Vadodara, Gujarat, India

Location

KLES Dr. Prabhakar Kore Hospital and Medical Research Centre

Belagavi, Karnataka, 590010, India

Location

Amrita Institute of Medical Sciences

Kochi, Kerala, 682041, India

Location

Regional Cancer Centre, Medical College

Trivandrum, Kerala, 695011, India

Location

JIPMER

Puducherry, Puducherry, 605006, India

Location

Sri Ram Cancer Hospital

Jaipur, Rajasthan, 302022, India

Location

Saveetha Medical College and Hospitals

Chennai, Tamil Nadu, 602105, India

Location

Sri Ramchandra Medical Centre

Chennai, Tamil Nadu, India

Location

MNJ Cancer Hospital

Hyderabad, Telangana, 500004, India

Location

King Georges Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Institute of Medical Sciences, BHU

Varanasi, Uttar Pradesh, 221005, India

Location

Related Publications (3)

• 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.

  PMID: 31916979 BACKGROUND

• 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.

  PMID: 19307994 BACKGROUND

• 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.

  PMID: 19075271 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

oregovomab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Jada Srinivasa Rao, PhD

  CanariaBio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 4, 2022
• Study Start: February 7, 2023
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): September 15, 2027
• Last Updated: April 1, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (14)