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Epithelial Ovarian CancerPhase 1/2ORION-02NCT04620954

Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

A Phase 1/2 study testing Oregovomab, Nivolumab and Chemotherapy in people with Epithelial Ovarian Cancer, run by National Cancer Centre, Singapore at 2 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, single-arm, phase I/II, single-center study with dose finding and dose expansion parts. This study hypothesizes that the combination of platinum-based chemotherapy, Oregovomab and Nivolumab will improve intracellular CA 125 antigen processing and elicit a stronger systemic CA 125-specific T cell… Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Oregovomab, Nivolumab and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesSingapore
Study dates
7 Oct 2020to Jul 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Written Informed Consent
  • Able to understand and voluntarily sign the Informed Consent Form (ICF). Written informed consent must be obtained before any study specific procedures that are not part of standard of care.
  • Willing and able to comply with scheduled visits, treatment schedule, laboratory test, and other protocol requirements
  • Age ≥ 21 years old
  • Age and Target Population
  • Histologically and/or cytologically confirmed diagnosis of epithelial ovarian, fallopian tube and primary peritoneal carcinoma (including carcinosarcoma)
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  • Serum CA 125 level at enrollment must be at least 5 times the upper limit of normal (ULN) using local laboratory ranges
  • Objective evidence of disease progression after 2 to 3 prior lines of cytotoxic chemotherapy including (neo)adjuvant platinum-based regimen for advanced stage disease. Patients may have received prior treatment with Bevacizumab and/or poly ADP ribose polymerase (PARP) inhibitor in any line, including as maintenance therapy.
  • Disease progression occurring at least 6 months after the last dose of platinum therapy was given following the penultimate line of chemotherapy before enrollment
  • Presence of:
  • measurable disease as defined by RECIST v1.1 AND a pre-treatment serum CA 125 level ≥ 5 times ULN on 1 occasion, OR
  • non-measurable but evaluable disease such as ascites and pleural effusions attributable to disease or radiologic abnormalities that do not meet RECIST v1.1 criteria AND a pre-treatment serum CA 125 level ≥ 5 times ULN on 2 occasions at least 1 week apart, OR
  • non-evaluable, non-measurable disease as defined by RECIST v1.1 AND pre- treatment CA 125 level ≥ 5 times ULN on 2 occasions at least 1 week apart
  • Estimated life expectancy greater than 3 months
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Adequate hematologic and end organ function, defined by the following local laboratory results obtained within 14 days before study entry:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
  • White Blood Cell (WBC) count ≥ 2.0 × 109/L
  • Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine clearance (CrCl) ≥ 30 ml/min according to Cockcroft-Gault formula
  • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN (or ≤ 5 x ULN in patients with liver metastases)
  • Serum bilirubin ≤ 1.5 x ULN (except patients with known Gilbert's disease who have serum bilirubin level ≤ 3 x ULN)
  • Normal Thyroid Stimulating Hormone (TSH) and free Thyroxine (fT4) levels
  • Recovery of acute AEs of prior anticancer therapies, including surgery and radiotherapy, to baseline or CTCAE grade ≤ 1 before study entry
  • Reproductive Status
  • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) within 24 hours before study entry
  • No breastfeeding
  • WOCBP must agree to observe abstinence from heterosexual sexual intercourse, or use contraceptive methods that results in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of Nivolumab.

Who cannot join

  • Cancer-specific Exclusions
  • Non-epithelial ovarian tumors or ovarian tumors with low malignant potential (i.e., borderline tumors). Note: ovarian carcinosarcomas are eligible.
  • Active symptomatic central nervous system (CNS) metastases. Patients with previous CNS metastases are eligible provided that they underwent CNS irradiation, are asymptomatic, do not require treatment with radiation therapy or anticonvulsants, and have stable disease at the screening tumor assessment. In addition, these patients must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisolone (or equivalent).
  • Spinal cord compression not definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated spinal cord compression are eligible provided that they have stable disease at the screening tumor assessment. In addition, these patients must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisolone (or equivalent).
  • Leptomeningeal carcinomatosis
  • Uncontrolled pleural effusion(s), pericardial effusion or ascites requiring recurrent drainage procedures (Patients with functioning pleural and/or peritoneal drainage catheters/devices in situ at time of study entry may be eligible.)
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  • Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years before study entry AND no additional therapy is required, or anticipated to be required, during the study period
  • General Medical Exclusions
  • Pregnant or lactating women
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months before study entry, unstable arrhythmias/heart block, or unstable angina
  • Severe infections within 4 weeks before study entry including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • History of abdominal fistula, history of gastrointestinal perforation, and signs or symptoms of bowel obstruction
  • Symptoms or radiological evidence of active bowel obstruction
  • Non-healing wound or ulcer, or bone fracture within 3 months before study entry.
  • Concurrent anticancer treatment within 28 days before study entry, e.g. cytotoxic chemotherapy, radiotherapy (except for palliative bone-directed radiotherapy), immunotherapy, cytokine therapy (except for erythropoietin); major surgery within 28 days before study entry (excluding diagnostic biopsy); use of hormonal agents within 7 days before study entry; or use of any investigational drug within 28 days before study entry. Patients receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before study entry.
  • Seizure disorder requiring anti-epileptic medication
  • Renal failure requiring hemo- or peritoneal dialysis
  • Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or administration of Investigational Products (IPs), or interfere with the interpretation of safety results
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Exclusions Related to Investigational Products
  • Other concurrent/ongoing systemic investigational agents
  • Previous assignment to treatment during this study. Subjects permanently withdrawn from study treatment participation will not be allowed to re-enter the study.
  • History of severe allergic, anaphylactic or other hypersensitivity reactions attributed to murine or humanized antibodies or fusion protein, biopharmaceuticals produced in Chinese hamster ovary cell products, or compounds of similar chemical or biologic composition to platinum(s), PLD, Oregovomab or Nivolumab
  • Prior treatment with anti-CA 125 cancer vaccine, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA 4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Active, known or suspected autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Subjects with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded.
  • Active use of systemic corticosteroids (≥ 10mg/day prednisolone or equivalent) or other systemic immunosuppressive agents (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF) agents) within 7 days before study entry, or anticipated requirement for systemic immunosuppressive medications during the study, with the following exceptions:
  • Systemic corticosteroids at physiologic doses to treat adrenocortical insufficiency not to exceed 10 mg/day of prednisolone or equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g. premedication for Carboplatin, PLD or CT contrast medium)
  • Intranasal, inhaled, ophthalmic topical glucocorticoids, local (e.g. intra-articular) steroid injections, and systemic mineralocorticoids (e.g. fludrocortisone)
  • History of solid organ allograft or allogeneic hematopoietic stem cell transplantation
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
  • Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive antibody to hepatitis B core antigen (anti-HBc) antibody test) are eligible. Patients with hepatitis B (HBV) infection (defined as having a positive HBsAg test) AND undetectable HBV DNA titer are also eligible.
  • Active tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks before study entry, or anticipation that such a live attenuated vaccine will be required during the study
  • Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
  • Other Exclusions Criteria
  • Inability to attend or comply with treatment of follow-up scheduling

Trial locations and contacts

2 sites in 1 country.

Jack Chan, MD contact

6436 8000

jack.chan.j.j@singhealth.com.sg

Singapore2 sites, 2 recruiting

  • National University Hospital

    Singapore, 119074

    David Tan, MD, 67795555, david_sp_tan@nuhs.edu.sg

    Not yet recruiting

  • National Cancer Center Singapore

    Singapore, 169690

    Jack Chan, MD, 64368000, jack.chan.j.j@singhealth.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: A Phase I/II Clinical Trial to Evaluate Platinum-based Chemotherapy, Oregovomab and Nivolumab in Patients With Platinum Sensitive Recurrent Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

This is an open-label, single-arm, phase I/II, single-center study with dose finding and dose expansion parts.

This study hypothesizes that the combination of platinum-based chemotherapy, Oregovomab and Nivolumab will improve intracellular CA 125 antigen processing and elicit a stronger systemic CA 125-specific T cell response and that it will be in a manner that is synergistic, safe and clinical efficacious in patients with relapsed platinum sensitive epithelial ovarian carcinoma (EOC).

Being tested
Oregovomab, Nivolumab, Chemotherapy
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OregovomabDrug

    2mg of Oregovomab is administered through IV on Weeks 1, 5, 9, 17.

  • NivolumabDrug

    480mg of Nivolumab is administered through IV every 4 weeks (Weeks 9, 13, 17, 21).

  • ChemotherapyDrug

    Pegylated liposomal doxorubicin (PLD) and carboplatin are administered every 4 weeks through IV. The starting dose of PLD and carboplatin are 30mg/m^2 and 5 AUC (Area Under the Curve) respectively.

Study groups in NCT04620954
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Drug: Oregovomab; Drug: Nivolumab; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of incidences of adverse events (AE)

    Measured: From time of start of treatment to the date of disease progression or death due to any cause, up to 2 years

  2. Proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR)

    Objective response rate

    Measured: From time of start of treatment to CR or PR, up to 2 years

Secondary outcomes (3)

  1. Proportion of patients with best overall response of CR, PR, or Stable Disease (SD)

    Disease control rate

    Measured: From time of start of treatment to CR, PR or SD, up to 2 years

  2. Progression free survival

    Measured: From time of start of treatment to first documented progression or death due to any cause, up to 2 years

  3. Overall survival

    Measured: From time of start of treatment to time of death due to any cause, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start7 Oct 2020
  3. Primary completionJul 2022 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04620954
Sponsor's protocol ID
NCC OV-03
Acronym
ORION-02
Status last verified
Dec 2020
First submitted
3 Nov 2020
Last updated
1 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oregovomab, Nivolumab and Chemotherapy in people with Epithelial Ovarian Cancer, run by National Cancer Centre, Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jack Chan, MD (6436 8000, jack.chan.j.j@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of incidences of adverse events (AE) (time frame: From time of start of treatment to the date of disease progression or death due to any cause, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04620954.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.

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