Trial Title:
Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer
NCT ID:
NCT05605535
Condition:
Ovarian Neoplasm Epithelial
Ovarian Cancer
Fallopian Tube Neoplasms
Peritoneal Carcinoma
Ovarian Serous Adenocarcinoma
Conditions: Official terms:
Carcinoma
Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cystadenocarcinoma, Serous
Fallopian Tube Neoplasms
Paclitaxel
Carboplatin
Oregovomab
Conditions: Keywords:
Ovarian cancer
Phase 2
Oregovomab
Chemoimmunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
Oregovomab
Description:
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
Arm group label:
Combination of Oregovomab and chemotherapy
Other name:
MAb-B43.13
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
175 mg/m^2, every 3 weeks
Arm group label:
Combination of Oregovomab and chemotherapy
Arm group label:
Combination of Placebo and chemotherapy
Other name:
Taxol
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC 5 or 6 IV Day 1 x 6 cycles (every 21 days)
Arm group label:
Combination of Oregovomab and chemotherapy
Arm group label:
Combination of Placebo and chemotherapy
Other name:
Paraplatin
Intervention type:
Biological
Intervention name:
Placebo
Description:
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
Arm group label:
Combination of Placebo and chemotherapy
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.
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.
Criteria for eligibility:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Women 18 years of age and older
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
King George Hospital
Address:
City:
Visakhapatnam
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Shilpa Kandipalli, MD
Phone:
9440731463
Email:
ShilpaKandipalli@gmail.com
Contact backup:
Last name:
Srikanth
Phone:
7893044572
Email:
srikanthgalaxycrservices@gmail.com
Facility:
Name:
Omega Hospitals
Address:
City:
Visakhapatnam
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Ravishankar Bellala, MD
Phone:
9849123256
Email:
dr.bellalaravishankar@gmail.com
Contact backup:
Last name:
Navya Jyothi B
Phone:
8919032324
Email:
navyajyothigalaxycrservices@gmail.com
Facility:
Name:
Himalaya Cancer Hospital and Research Institute
Address:
City:
Vadodara
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Kartikeya Jain, MD
Phone:
9427432642
Email:
Dr.kartikeyresearch@gmail.com
Contact backup:
Last name:
Dr Abhilasha Jha
Phone:
9611725715
Email:
Clinical.himalaya@gmail.com
Facility:
Name:
Kailash Cancer Hospital and Research Centre
Address:
City:
Vadodara
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Neeraj Bhat, MD
Phone:
9925581480
Email:
Niraj.bhatt@greenashram.org
Contact backup:
Last name:
Nidhi
Phone:
9426558547
Facility:
Name:
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Address:
City:
Belgaum
Zip:
590010
Country:
India
Status:
Recruiting
Contact:
Last name:
Mahesh kumar Kalloli, Dr
Phone:
+91 9945014996
Email:
Mahesh.kalloli@gmail.com
Contact backup:
Last name:
Abdul Rehman Malik
Phone:
8951359555
Email:
Malikabd.cr@gmail.com
Facility:
Name:
Amrita Institute of Medical Sciences
Address:
City:
Kochi
Zip:
682041
Country:
India
Status:
Recruiting
Contact:
Last name:
k. Pavitran, Dr
Phone:
+91 9895367090
Email:
pavithrank@aims.amrita.edu
Contact backup:
Last name:
Bhajanlal K
Phone:
9946041789
Email:
bhajanlalk@aims.amrita.edu
Facility:
Name:
Regional Cancer Centre, Medical College
Address:
City:
Trivandrum
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Ashwin Kumar, MD
Phone:
9847061548
Email:
Ashwinrad1@gmail.com
Contact backup:
Last name:
Salini George
Email:
Saline.rccresearch@gmail.com
Facility:
Name:
Acharya Vinoba Bhave Rural Hospital Wardha
Address:
City:
Wardha
Zip:
442004
Country:
India
Status:
Withdrawn
Facility:
Name:
Sri Ram Cancer Hospital
Address:
City:
Jaipur
Zip:
302022
Country:
India
Status:
Recruiting
Contact:
Last name:
Hemant Malhotra, Dr
Phone:
9829962040
Email:
drmalhotrahemant@gmail.com
Contact backup:
Last name:
Ms. Raunak Vaishnav
Phone:
+91 8005698092
Email:
raunak.vaishnav@mgumst.org
Facility:
Name:
Saveetha Medical College and Hospitals
Address:
City:
Chennai
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Anita Ramesh, MD
Phone:
9840758567
Email:
dranitaramesh.crf@gmail.com
Contact backup:
Last name:
Supriya Mohan
Email:
Clinicaltrials.smc@saveetha.com
Facility:
Name:
Sri Ramchandra Medical Centre
Address:
City:
Chennai
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Ganesan TS, MD
Phone:
8754555099
Email:
tsganesan@gmail.com
Contact backup:
Last name:
Om Sibby Chakravarthy
Phone:
7200188619
Email:
srmconco@gmail.com
Facility:
Name:
MNJ Cancer Hospital
Address:
City:
Hyderabad
Zip:
500004
Country:
India
Status:
Recruiting
Contact:
Last name:
Krishna Kadarla, Dr
Phone:
6281626162
Email:
mnjiorcckrishnakadarla@gmail.com
Contact backup:
Last name:
Sasivardhana Raju
Phone:
9828343913
Email:
sasirajum@gmail.com
Facility:
Name:
King Georges Medical University
Address:
City:
Lucknow
Zip:
226003
Country:
India
Status:
Recruiting
Contact:
Last name:
Vijay Kumar, Dr
Phone:
993538366
Email:
dr.vkumar2007@gmail.com
Contact backup:
Last name:
Mohit Kuma Singh
Phone:
6393157866
Email:
Singh.mohit99@gmail.com
Facility:
Name:
Institute of Medical Sciences, BHU
Address:
City:
Varanasi
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Tarun Kumar, MD
Phone:
9969522761
Email:
batra_tarun@hotmail.com
Contact backup:
Last name:
Ramanand
Phone:
9670025320
Email:
rnyadav953@gmail.com
Facility:
Name:
N.R.S. Medical College And Hospital
Address:
City:
Kolkata
Zip:
700014
Country:
India
Status:
Withdrawn
Facility:
Name:
JIPMER
Address:
City:
Pondicherry
Zip:
605006
Country:
India
Status:
Recruiting
Contact:
Last name:
Prashant Ganeshan, Dr
Phone:
9940339189
Email:
pg1980@gmail.com
Contact backup:
Last name:
N.Ratheesh
Phone:
9743449459
Email:
nratheesh86@gmail.com
Start date:
February 7, 2023
Completion date:
May 15, 2026
Lead sponsor:
Agency:
CanariaBio Inc.
Agency class:
Industry
Collaborator:
Agency:
Raptim Research Pvt. Ltd
Agency class:
Other
Source:
CanariaBio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05605535
