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

NCT05407584 | Unknown Phase 2

• 1 other identifier: 4-2022-0430
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

PARP inhibitor Resistant; platinum resistant

Outcome Measures

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

  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 (6)

• progression-free survival

  Up to 1 years

• Overall survival (OS)

  Up to 1 years

• Time to first Subsequent Therapy

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

• Time to Second Subsequent Therapy

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

• Duration of response

  Up to 1 years

Study Arms (2)

Cohort 1(1-3 prior line of chemotherapy)

EXPERIMENTAL

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

Drug: Orevogomab+PLD

Cohort2 (>3prior line of chemotherapy)

EXPERIMENTAL

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

Drug: Orevogomab+Paclitaxel

Interventions

Orevogomab+PLD DRUG

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

Cohort 1(1-3 prior line of chemotherapy)

Orevogomab+Paclitaxel DRUG

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

Cohort2 (>3prior line of chemotherapy)

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 20 years old or older.
• Subjects with histologically confirmed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.
• 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.).
• \[only up to 5 patients with non-high grade serous carcinoma will be included\]
• Prior PARP inhibitor exposure (progressed through a prior PARP inhibitor)
• CA-125 ≥ 50 U/ml
• Prior platinum-based chemotherapy.
• Cohort 1 : 1-3 prior lines of therapies / Cohort 2 : Previous treatments of the 4th line or more.
• 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)
• Received prior bevacizumab or not eligible for bevacizumab due to medical.
• 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 first dose of study treatment).
• Adequate liver function:

You may not qualify if:

• Participant has mucinous, germ cell, or borderline tumor of the ovary.
• 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.
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• 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.
• Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab and PLD.
• Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc.
• 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.
• 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 subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, 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.
• 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.

Sponsors & Collaborators

• Yonsei University: lead
• CanariaBio Inc.: collaborator

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Park J, Cho HW, Lim MC, Choi CH, Lee JY. OPERA: a phase II trial of oregovomab plus non-platinum chemotherapy in PARP inhibitor/platinum-resistant ovarian cancer. Future Oncol. 2024;20(26):1893-1899. doi: 10.1080/14796694.2024.2357533. Epub 2024 Jun 28.

  PMID: 38940373 DERIVED

Study Officials

• Jung-Yun Lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Yun Lee

CONTACT

82-2-2228-2237; jungyunlee@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: July 5, 2022
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)