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

NCT04620954 | Unknown Phase 1

• 1 other identifier: NCC OV-03
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief 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 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).

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Number of incidences of adverse events (AE)

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

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

  Objective response rate

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

Secondary Outcomes (3)

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

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

• Progression free survival

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

• Overall survival

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

Study Arms (1)

Intervention

EXPERIMENTAL

Drug: Oregovomab; Drug: Nivolumab; Drug: Chemotherapy

Interventions

Oregovomab DRUG

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

Intervention

Nivolumab DRUG

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

Intervention

Chemotherapy DRUG

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.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.)
• 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
• 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

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• CanariaBio Inc.: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (2)

National University Hospital

Singapore, 119074, Singapore

NOT YET RECRUITING

National Cancer Center Singapore

Singapore, 169690, Singapore

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

oregovomab; Nivolumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Jack Chan, MD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Chan, MD

CONTACT

6436 8000; jack.chan.j.j@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: October 7, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 1, 2021

Record last verified: 2020-12

Locations

SG (2)