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Ovarian NeoplasmsPhase 2NCT01616303

A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

A Phase 2 study testing Carboplatin, Paclitaxel and oregovomab in people with Ovarian Neoplasms, run by Quest PharmaTech Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
Carboplatin, Paclitaxel and oregovomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
2 sitesUnited States
Study dates
15 Jun 2012to 12 Oct 2018
Phase
Phase 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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage III/IV disease.
  • have preoperative CA125 levels > 50 U/mL
  • have optimal cytoreduction (RT<1)
  • be anticipated to have first-line chemotherapy infusion within 6 weeks after surgery
  • be available to complete the protocol for the duration of the study
  • have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/µL, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1. Platelets greater than or equal to 100,000/µL; hemoglobin greater than or equal to 8.0 g/dL
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  • have adequate Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1
  • have adequate Hepatic function: bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
  • able to sign informed consent and provide authorization permitting release of personal health information
  • have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Who cannot join

  • have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis)
  • have a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or cannot tolerate cyclophosphamide
  • are being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids.
  • have a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia
  • have an acquired, hereditary, or congenital immunodeficiency
  • have uncontrolled diseases other than cancer
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  • have contraindications to the use of pressor agents
  • have undergone more than one surgical debulking
  • have hepatic dysfunction, eg, bilirubin more than 1.5 times higher than normal levels, lactate dehydrogenase (LDH), serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) doubled compared to normal or albumin <3.5 g/dL
  • have severe renal insufficiency with serum creatinine >1.6 mg/dL
  • have concomitant diseases or treatments that may confound the results of the study, which may preclude the completion of the protocol or may mask adverse reactions
  • are to be tested with other medications during treatment
  • are unable to read or understand or unable to sign the necessary written consent before starting treatment

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

Other trials in United States

About this study

Official title: Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma

This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.

Read the detailed description

Oregovomab is an investigational drug previously used in clinical trials as an immunotherapeutic treatment of ovarian cancer patients whose tumor cells express the tumor associated antigen, CA125. The active component of oregovomab is the activated murine monoclonal antibody B43.13, an immunoglobulin G1k (IgG1k) subclass immunoglobulin that binds with high affinity (1.16E10/M) to CA125.

CA125 is a surface glycoprotein antigen that is expressed on more than 80% of all non-mucinous epithelial ovarian carcinomas where it occurs at elevated levels in the serum of patients with ovarian cancer. Little is known about its biological function. CA125 is associated with a large molecular weight mucin-like glycoprotein complex of 200-250 kilodaltons (kDa) and its genetic structure has recently been elucidated. There is good evidence to suggest that CA125 is a relevant target antigen for antigen-mediated immunotherapy of ovarian cancer.

The study will compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.

Being tested
Carboplatin, Paclitaxel, oregovomab
Keywords
ovarian, cancer, neoplasm, adenocarcinoma, CA125
Medical subject headings
Ovarian Neoplasms, Neoplasms, Adenocarcinoma

What participants receive

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

  • CarboplatinDrug

    carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days])

  • PaclitaxelDrug

    Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days])

  • oregovomabBiological

    Also called OvaRex

    oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).

Study groups in NCT01616303
Study groupRoleWhat they receive
carboplatin & paclitaxelActive comparatorfirst-line chemotherapy for ovarian cancer
Receives: Drug: Carboplatin; Drug: Paclitaxel
carboplatin & paclitaxel & oregovomabExperimentalfirst-line chemotherapy for ovarian cancer plus oregovomab
Receives: Drug: Carboplatin; Drug: Paclitaxel; Biological: oregovomab

What is being measured

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

  1. CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy

    Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy

    Measured: At Baseline (up to 4 weeks before Cycle 1), at Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1)

Secondary outcomes (4)

  1. Time to clinical relapse

    The time period from the date of randomization to the date of confirmed relapse as defined by clinical, radiologic, and/or pathologic evaluations.

    Measured: Up to three years after treatment in the study

  2. Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity)

    Laboratory test for human anti-mouse antibody (HAMA) present in patients' sera. DTH (delayed type hypersensitivity) is an on-site test conducted by the investigator by injecting a small amount of the Oregovomab product and three other antigens (mumps, tetanus, and Candida) into the skin of the patient and observing the effects.

    Measured: Up to three years after treatment in the study

  3. Clinical response

    Patients will be categorized into one of the following: increasing disease, stable disease, or progression [measurable disease studies]

    Measured: Up to three years after treatment in the study

  4. Overall Survival

    The observed length of life from entry into the study to death or the date of last contact

    Measured: Up to three years after treatment in the study

Timeline

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

  1. First posted11 Jun 2012 (estimated)
  2. Study start15 Jun 2012
  3. Primary completion15 Jun 2015
  4. Study completion12 Oct 2018

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01616303
Sponsor's protocol ID
QPT-ORE-002
Other IDs
2010-024305-13
Status last verified
Sep 2020
First submitted
30 May 2012
Last updated
14 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brewer M, Angioli R, Scambia G, Lorusso D, Terranova C, Panici PB, Raspagliesi F, Scollo P, Plotti F, Ferrandina G, Salutari V, Ricci C, Braly P, Holloway R, Method M, Madiyalakan M, Bayever E, Nicodemus C. Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study. Gynecol Oncol. 2020 Mar;156(3):523-529. doi: 10.1016/j.ygyno.2019.12.024. Epub 2020 Jan 6.

    PubMed 31916979

  • Battaglia A, Buzzonetti A, Fossati M, Scambia G, Fattorossi A, Madiyalakan MR, Mahnke YD, Nicodemus C. Translational immune correlates of indirect antibody immunization in a randomized phase II study using scheduled combination therapy with carboplatin/paclitaxel plus oregovomab in ovarian cancer patients. Cancer Immunol Immunother. 2020 Mar;69(3):383-397. doi: 10.1007/s00262-019-02456-z. Epub 2020 Jan 3.

    PubMed 31897661

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and oregovomab in people with Ovarian Neoplasms, run by Quest PharmaTech Inc. at 2 sites in United States.

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 10 inclusion and 13 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: finished, as of the sponsor's last update on 14 Sep 2020. 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 United States. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy (time frame: At Baseline (up to 4 weeks before Cycle 1), at Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1)). 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 NCT01616303, which also lists 2 linked publications.

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 14 Sep 2020.

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