Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05605535
Other study ID # QPT-ORE-006
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 7, 2023
Est. completion date May 15, 2026

Study information

Verified date August 2023
Source CanariaBio Inc.
Contact Clinical Operations
Phone 1-780-448-1400
Email ClinicalTrialDisclosures@oncoquestinc.com
Is FDA regulated No
Health authority
Study type Interventional

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date May 15, 2026
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Biological:
Oregovomab
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
Drug:
Paclitaxel
175 mg/m^2, every 3 weeks
Carboplatin
AUC 5 or 6 IV Day 1 x 6 cycles (every 21 days)
Biological:
Placebo
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

Locations

Country Name City State
India KLES Dr. Prabhakar Kore Hospital and Medical Research Centre Belgaum Karnataka
India Saveetha Medical College and Hospitals Chennai Tamilnadu
India Sri Ramchandra Medical Centre Chennai Tamilnadu
India MNJ Cancer Hospital Hyderabad Telangana
India Sri Ram Cancer Hospital Jaipur Rajasthan
India Amrita Institute of Medical Sciences Kochi Kerala
India N.R.S. Medical College And Hospital Kolkata West Bengal
India King Georges Medical University Lucknow Uttar Pradesh
India JIPMER Pondicherry
India Regional Cancer Centre, Medical College Trivandrum Kerala
India Himalaya Cancer Hospital and Research Institute Vadodara Gujarat
India Kailash Cancer Hospital and Research Centre Vadodara Gujarat
India Institute of Medical Sciences, BHU Varanasi Uttar Pradesh
India King George Hospital Visakhapatnam Andhra Pradesh
India Omega Hospitals Visakhapatnam Andhra Pradesh
India Acharya Vinoba Bhave Rural Hospital Wardha Wardha Maharashtra

Sponsors (2)

Lead Sponsor Collaborator
CanariaBio Inc. Raptim Research Pvt. Ltd

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
At 3 months
Secondary 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
At 3 months
Secondary 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) At 4 months
Secondary 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. Approximately up to 4 years
Secondary Overall Survival Overall survival is defined as date of randomization to date of death due to any cause. Approximately up to 8 years
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2