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RecruitingNCT05407584Updated May 24, 2023

Oregovomab and PLD in PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

A Phase 2 interventional study of Orevogomab+PLD and Orevogomab+Paclitaxel in PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Yonsei University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
20 Years and older
Sex
Female
01

Study summary

This study is phase II, open label, clinical trial to determine the efficacy of Oregovomab and non-platinum chemotherapy in PARP inhibitor resistant ovarian, fallopian tube, or primary peritoneal cancer patients who were not suitable for platinum retreatment.

Patients who have received one to three prior lines of chemotherapy are to be assigned to Cohort 1 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + pegylated liposomal doxorubicin [PLD] 40 mg/m2 q4w, n=28), while patients who have received more than three prior lines of chemotherapy are to be assigned to Cohort 2 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + weekly paclitaxel 80 mg/m2 [D1,8,15 q4w], n=28). A total of 56 patients will be recruited and treated with oregovomab + PLD / weekly paclitaxel until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint is objective response rate by RECIST 1.1.

Read the detailed description

This study is a two-cohort, single arm phase II study in patients with PARP inhibitor-resistant ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of five administrations of Oregovomab 2mg IV in combination with non-platinum chemotherapy will be evaluated with recurrent ovarian cancer who have progressed with prior PARP inhibitor treatment.

Patients with disease under study will be screened for eligibility during the period 28 days immediately prior to starting study drug on Day 1. Laboratory and radiological assessments performed as part of standard of care before signing informed consent may be used if performed within the screening/baseline time window.

During this time, the inclusion and exclusion criteria will be assessed and all screening assessments, laboratory tests, and procedures will be performed.

Cohort 1(1-3 prior line of chemotherapy) PLD (40 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks (28 days) Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following PLD over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7

Cohort2 (>3prior line of chemotherapy) paclitaxel (80 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks on day 1, 8, 15

Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following paclitaxel over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7

02

Conditions studied

  • PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

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Keywords

  • PARP inhibitor Resistant
  • platinum resistant
03

In context

Peritoneal Neoplasms

361 studies on the registry are indexed under Peritoneal Neoplasms; 56 are open to participants now.

This study's planned enrollment of 56 is above the median of 45 across 288 interventional studies indexed under Peritoneal Neoplasms.

Browse Peritoneal Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults 20 years old or older.
  2. Subjects with histologically confirmed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.
  3. Eligible histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, , and low-grade adenocarcinoma, or adenocarcinoma not otherwise specified (N.O.S.).

    [only up to 5 patients with non-high grade serous carcinoma will be included]

  4. Prior PARP inhibitor exposure (progressed through a prior PARP inhibitor)
  5. CA-125 ≥ 50 U/ml
  6. Prior platinum-based chemotherapy.
  7. Cohort 1 : 1-3 prior lines of therapies / Cohort 2 : Previous treatments of the 4th line or more.
  8. Not eligible for platinum re-treatment (prior allergic reaction or residual toxicity, patients who are not able to receive (in the physician's opinion) or willing to receive platinum treatment and platinum resistant patients)
  9. Received prior bevacizumab or not eligible for bevacizumab due to medical.
  10. 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 first dose of study treatment).
  11. Adequate liver function:

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

    a. Creatinine ≤ 1.5 times ULN

  13. ECOG Performance Status of 0 or 1.
  14. For 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 60 days after last dose of study treatment.
  15. Sign informed consent and authorization permitting release of personal health information.

Exclusion criteria

Exclusion Criteria:

  1. Participant has mucinous, germ cell, or borderline tumor of the ovary.
  2. Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment.
  3. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  4. Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
  5. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab and PLD.
  6. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc.
  7. Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper.
  8. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
  9. Clinically significant active infection(s) at the time of screening.
  10. Any of the following conditions (on-study testing is not required):

    1. Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, 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).
  11. Uncontrolled or life-threatening diseases compromising safety evaluation.
  12. Participant has a known additional malignancy that is progressing or has required active treatment within the past 2 years.

    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, endometrial carcinoma) that have undergone potentially curative therapy are not excluded.

    Note: Participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than IA: no more than superficial myometrial invasion.

  13. Contraindications to the use of pressor agents
  14. History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases.
  15. 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 (see Appendix H).
    3. Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings.
  16. Unable to read or understand or unable to sign the necessary written consent before starting treatment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Cohort 1(1-3 prior line of chemotherapy)

    Oregovomab and PLD is synergistic in PARPi-resistant recurrent ovarian cancer.

    Drug: Orevogomab+PLD

  • Experimental
    Cohort2 (>3prior line of chemotherapy)

    Oregovomab and Paclitaxel show synergistic in PARPi-resistant recurrent ovarian cancer.

    Drug: Orevogomab+Paclitaxel

Interventions

  • DrugOrevogomab+PLD

    PLD (40 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks (28 days) Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following PLD over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7

  • DrugOrevogomab+Paclitaxel

    paclitaxel (80 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks on day 1, 8, 15 Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following paclitaxel over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7

06

What researchers measure

Primary outcomes

  1. Confirmed ORR

    based on radiographically confirmed response according to CR+PR rate based on RECIST v1.1 as determined by the investigator

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes

  1. progression-free survival

    PFS is calculated as the interval in months from the date of enrollment to the date of disease progression or the date of death, whichever comes first.

    Time frame: Up to 1 years

  2. Overall survival (OS)

    Overall survival (OS) will be calculated using the date of death OS is calculated as the interval in months from the date of enrollment to the date of death.

    Time frame: Up to 1 years

  3. Time to first Subsequent Therapy

    TFST, defined as time from the date of enrollment into the study to second anti-cancer therapy start date following study treatment completion, treatment exit \[EOT\] or death, will be determined.

    Time frame: The date of first documented first subsequent treatment or date of death, assessed up to 72 months

  4. Time to Second Subsequent Therapy

    TSST, defined as time from the date of enrollment into the study to third anti-cancer therapy start date following study treatment completion, treatment exit \[EOT\] or death, will be determined.

    Time frame: The date of first documented second subsequent treatment assessed up to 72 months

  5. Duration of response

    DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1

    Time frame: Up to 1 years

  6. second objective disease progression

    PFS2, defined as the time from enrollment into the study to the earlier date of progression on next-line therapy or death from any cause, will be determined.

    Time frame: Up to 1 years

07

Study locations

1 of 1 sites recruiting
  • Yonsei University Health System, Severance Hospital
    Seoul, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05407584
Lead sponsor
Yonsei University
Collaborators
CanariaBio Inc.
Responsible party
Sponsor
First posted
Jun 7, 2022
Start date
Jul 5, 2022
Primary completion
May 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
May 24, 2023

Study contacts

Jung-Yun Lee
Contact
jungyunlee@yuhs.ac
82-2-2228-2237
Jung-Yun Lee
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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